PML, Inc.
Quality Assurance Manual
General Information and Approvals
SCOPE:
PML, Inc. is committed to customer satisfaction, excellence of our products and services, andcontinual improvement. To realize these objectives, we have implemented and will maintain aquality system that meets the requirements of ISO 9001:2015 and IATF16949:2016.
Our scope of registration is:
The manufacturer of injection molded and extruded rubber components.
Exclusion: PML, Inc does not perform product design and/or embedded software. This
responsibility is outsourced to Marugo Rubber Industries.
PML receives all specifications from customers for product design.
PML, Inc. does not produce or process materials, from external providers, containing
embedded software.

RESPONSIBILITIES:The IATF16949 Management Representative maintains the Quality System Manual. The process
for updating the Quality System Manual and methods for determining the revision history aredetailed in the Log of Revisions of the Quality Manual.

DISTRIBUTION:
PML, Inc. electronically accesses the Quality System Manual. Printed copies are for reference
only. The methods for control and distribution are explained in the Log of Revisions in the
Quality Manual.

APPROVAL:
PML, Inc. records the revision level, issue date and authorized functions in the Quality System
Manual. The Quality Manager approves policy changes to the Quality System Manual. The
Registrar is informed in writing of significant changes to the Quality System.

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Quality Assurance Manual
TABLE OF CONTENTS
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General Information and Approvals
Table of Contents
Log of Revisions
Presentation of the Company
Organization of the Company
Terms and Definitions
Context of PML, Inc.
P-D-C-A Model
Processes
Customer / Support Process Table
Process Interaction Matrix
Leadership and Commitment
Planning
SupportOperations
Performance Evaluation
Improvement
Level II Procedures

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LOG OF REVISIONSThe IATF16949 Management Representative will process all authorized changes, issue copies
for distribution, where appropriate, and ensure any obsolete copies are destroyed. The MasterCopy of this quality manual, kept in the custody of the IATF Management Representative, shallbe the final authority as to revision status for all sections in the manual.
Date

07-28-04
01-04-06
09-04-08
8-18-09
05-11-10
04-19-11
10-19-11
10-11-12
07-06-15
07-27-16
07-19-18
08-9-18

Rev.
Level

A
B
C
D
E
F
G
H
I
J
K
L

SectionOriginal Issue
See DCR #06-0003
See DCR #08-0029
See DCR #09-0023
See DCR #10-0026
See DCR #11-0010
See DCR #11-0057
See DCR #12-0037
See DCR #15-0020
See DCR #16-0015
See DCR #18-0022
See DCR #18-0029

Details

Prep By:

Checked By:

Approved By:

Ira Greer

Pat Barrow

Kristen Carper

See DCR #20-0013

Kristen Carper

Pat Barrow
MaeganStubblefield
Lisa
ShawhanIra Greer

5-19-20

M

All
6.2.2.4
Page 4
Page 4
5.0 & Scope
2
9
Appendix
All
All
All
6.2 & 6.3
Scope &
Process Matrix

5-25-21N

Page 5

See DCR #21-0010

Kristen Carper

5/25/23

O

Page 43

See DCR #23-0007

Kristen Carper

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Ira Greer3

PML, Inc.
Quality Assurance Manual
Section I: Presentation of the Company
PML, Inc.
75 County Home Road
Paris, Tennessee
PML, Inc. is a privately held subsidiary of Marugo Rubber Industries of Japan and is amanufacturer of extruded hose and tubing, injection molded rubber components, and rubber tometal vibration isolation products.
Manufacturing excellence and continuous improvement are the top operating priorities at PML,
Inc. The quality system is designed to ensure that quality is built into the product by utilizing
advanced product planning and manufacturing stability and control.
PML, Inc. will maintain and continually improve the Quality System to ensure that ourcustomers’ expectations are met or exceeded.

Section II: Organization of the Company
Responsibility for quality rests with every associate at PML, Inc. PML, Inc. defines anddocuments descriptions for personnel who manage, perform and verify work affecting quality ina job description format. The interrelation of personnel affecting quality is represented on the
PML, Inc. organization chart. PML, Inc. designates key responsibilities as follows:
Executive Management – President, Vice Presidents and Directors have the responsibility andauthority to set the business objectives, quality goals, operational goals and other required goals
for the organization.
Quality Improvement Committee – President, Vice Presidents, Directors and/or otherdesignated representatives have the responsibility and authority for guiding and assisting
departments in the implementation of the quality goals and compliance to IATF16949.
Quality Manager – has the responsibility to maintain the quality management system and theauthority to institute corrective and preventive action and procedures consistent with the quality
goals. Serves the company as the IATF16949 management representative and as the customer
representative.
Vice-President of Sales/Purchasing, Engineering Manager, Quality Manager and the
Senior Material Engineer – have the responsibility to review contracts and confirm
specifications, including special characteristics, with the customer.
Vice-President of Sales/Purchasing – is responsible for purchasing materials that meet therequirements established by the quality system and tracking the performance of suppliers. This
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individual or their designate is also responsible for customer portals and receipt of customerscorecards.
Vice-President of Manufacturing/Engineering – is responsible for producing products ontime, to customer specifications and related capacity analysis. Manufacturing is responsible for
reducing variation and has the authority to initiate corrective and preventive action that will
result in the elimination of non-conforming product.
Maintenance Manager – is responsible for machine/equipment maintenance and the total
preventive maintenance system to ensure equipment functions and minimal down times.
Director of Human Resource – is responsible for the training activities, employee
communications, associate safety and resources to meet the quality system requirements.
Vice-President of Sales/Purchasing and the Logistics Manager – are responsible for all
logistic services to customers and from suppliers.
Vice-President of Manufacturing/Engineering, Engineering Manager, Quality Manager,
Material Manager, Director of H.R., Manufacturing Managers and the MaintenanceManager - are responsible for process design, including process safety, and related training
requirements.
Top Management, Managers, Supervisors, QC Technicians – are authorized to stop
shipments.
In the event of absence or abnormal conditions, an appointed designee will maintain andoversee the process and responsibilities of the assigned process owner.

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Section III: Terms and Definitions
8D – Multiple step Problem Solving System
5S – Simplify, Systemize, Sanitize, Standardize, Support
AIAG – Automotive Industry Action Group
APQP – Advanced Product Quality Planning
CPK – Measure of Process Capability
CMM – Coordinate Measuring Machine
EDI – Electronic Data Interchange
EMS – Environmental System Management
FIFO – First In First Out
FMEA – Failure Mode and Effect Analysis
R & R – Repeatability & Reproducibility
ISO – International Standards Organization
MSA – Measurement Systems Analysis
MRO – Maintenance, Repair and Operations
PPAP – Production Part Approval Process
PPM – Parts per Million Defects
QMS – Quality Management System
RFQ – Request for Quote
SDS – Safety Data Sheet
SPC – Statistical Process Control

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Section IV: The Context of PML, Inc.
4.1

Understanding PML, Inc. and its context.

PML, Inc. determines the external and internal issues that are relevant to its purpose, strategic
direction and that affects its ability to achieve the intended results of its QMS. PML, Inc. willcontinue to monitor and update these issues as required. Current issues identified include, but are
not limited to, the following:a) Competitors;b) Customers;c) Evolving automotive requirements involving rubber hoses, bushings, anti-vibration
products, etc.;d) Governmental requirements including, but not limited to, personnel safety
requirements, product requirements, local government requirements, etc.;e) Evolving manufacturing technologies, andf) Other issues as determined relevant by PML, Inc.
Process owners will analyze external and internal issues and update them accordingly. Theseissues will be reviewed during management review activities and the semi-annual executive
meetings and appropriate actions will be taken to address them as required.

4.2

Understanding the Needs and Expectations ofInterested Parties.

When the relevant parties are identified, PML, Inc. determines what products, services,
information and or data needs to be provided to them or provided to PML, Inc. by them. These
relevant interested parties and their expectations are reviewed as necessary by process owners
and reported in the management review sessions and semi-annual executive meetings.

4.3

Determining the Scope of the Quality Management System.

PML, Inc. determines and reviews the scope of the QMS by reviewing and analyzing the
products and services provided to our customers, the external and internal issues that affect ourability to meet the intended results of the QMS, needs and expectations of all identified
interested parties and remote support required by PML, Inc. Based on these results, PML, Inc.
determines the required scope of the QMS.
PML, Inc. has established and will maintain this quality manual, including reference to the
documented procedures established for the QMS. The controlled copy is maintained by the
IATF16949 Management Representative and all other copies are uncontrolled and are forreference only.

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PML, Inc.
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Determining the Scope of the Quality Management
System - Supplemental.

The scope of the QMS covers all relevant processes and activities to manufacture injection
molded and extruded rubber components while maintaining compliance with IATF16949:2016,
ISO9001:2015 and other relevant compliance standards.
The only exclusions to this manual are in relation to product design and embedded software.
PML, Inc. is not product design responsible nor does PML, Inc. supply any products withembedded software requirements.

4.3.2

Customer-Specific Requirements

Specific customer requirements are determined through APQP activities, contract review,
customer quality manuals, etc. These requirements are identified in the Specific Customer
Requirement Matrix.
MODEL OF THE PLAN-DO-CHECK-ACT BASED QUALITY MANAGEMENTSYSTEM USED BY PML, Inc.

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Listed below are the processes identified by PML, Inc.

Customer Oriented Processes
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Market Analysis
Bid/Quote
Production
Shipping / Receiving
Delivery
Post Sales/Customer Feedback

Support Processes
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•
•
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APQP / Program Management – Error prevention
Document Control
Purchasing / Supplier Management
Customer Approval Process (PPAP)
Human Resource – Training, Safety, Competence
Maintenance of Equipment, Preventative MaintenanceEngineering – Tooling, Engineering Specifications, Process Design
Control of Monitoring & Measuring Devices
QC – Identification, Traceability, Control of Reworked, Repaired andNon-Conforming Products
Information System
Control of Reworked, Repaired and Non-Conforming ProductsManagement Oriented Processes
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Management Review
Internal Audit Program
Monitoring, Measuring & Analysis
Continuous Improvement (Kaizen)
Corrective & Preventive Action
Customer Satisfaction
Problem Solving

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The table below shows the interactions between PML, Inc.’s
Customer processes and support processes
Producti on Producti on Producti on Producti on Producti on

MarketBid/Quote
Regular
THV
Analysis
MixingExtrusion Extrusion
APQP/
Program Mgt

RubberAll
to Metal Rubber
Molding Molding

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Maintenance/ Preventive
Maintenance

X

X

X

X

X

Tooling Engineering

X

X

X

X

X

Control of
Monitoring &Measuring
Devices

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Document
Control

X

Purchasing/
Supplier Mgt.

X

QC
Information
Systems

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X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

CustomerApproval(PPAP)
Human
Resources

Post Sales
Shipping //DeliveryReceiving
CustomerFeedback

X

X

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Process Interaction Matrix

Sales / Customer
Service

Purchasing

Information
Technology

Program (APQP)

PPAP

Quality Control /Customer Satisfaction

Engineering

Maintenance

Production Control

Regular Extrusion

THV Extrusion

MixingRubber to Metal
Bonding Molding

All Rubber Molding

Shipping / Receiving

S

S

S

S

S

S

S

S

S

S

S

S

S

S

S

S

4.2 Needs andexpectations ofinterested parties

Top Management

P

S

S

S

S

S

S

S

S

S

S

S

S

S

S

S

S

4.3 Determining
the scope of the
QMS

Top Management

P

4.4 Quality
management
system and its
processes

Top Management

P

S

S

S

S

S

S

S

S

S

S

S

S

S

S

S

4.4.1.2 - Product
Safety.

Assist. QC
Manager

S

S

S

S

S

S

P

S

S

S

S

S

S

S

S

S

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P

Top Management /Management Review

Top Management

Exclusion

4.1 Understanding
the organizationand its context

SectionTitle / Responsible
Number Party(s)Procedure

Human Resources

Corrective / Preventive
ActionProcesses Audited

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5.1.1 Leadership General

Top Management

P

5.2 Policy

Top Management

PS

5.3 Organizationalroles,
responsibilities andauthorities

Top Management

P

S

S

6.1 Actions toaddress risks andopportunities

Top Management

P

S

S

S

6.1.2.2 Preventive Action

Assist. QC
ManagerSS

6.1.2.3 Contingency plan

Top Management

P

S

S

6.2 Quality
objectives andplanning

Top Management

PS

6.3 Planning ofchanges

ProgramManagementS

7.1.1 Resources General

Top Management

P

S

S

P

7.1.2 People

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Quality Assurance Manual
7.1.3 Infrastructure

Top Management

P

7.1.4 Environment
for the operation ofprocesses

Top Management

P

7.1.5.1 Monitoring and
Measuring
Resources General

Top Management

P

7.1.5.2 Measurement
Traceability

Assist. QC
Manager

7.1.5.2.1 Calibration /Verification
Records

Assist. QC
ManagerX

7.1.5.3 Laboratory
Requirements

Assist. QC
ManagerX

7.1.6
Organizational
knowledge

Top Management

7.2 Competence

Human Resource
DirectorX

7.2.3 - Internal
AuditorCompetency

Assist. QC
ManagerX

7.3 Awareness

Top Management

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7.4
Communication

Top Management

7.5 Documented
information

Assist. QC
ManagerXS

7.5.1.1 - Quality
Management
SystemDocumentation

Assist. QC
ManagerXS

7.5.3.2.2 Engineering
Specifications

Engineering
ManagerX

8.1 Operational
planning andcontrol

Top Management

P

S

S

S

S

S

8.2 Requirementsfor products andservices

ProgramManagement

S

S

S

S

S

P

8.2.1 Customer
communication

VP Sales &Purchasing

SS

8.2.2 Determining
product/service
requirements

VP Sales &Purchasing

X

S

P

S

S

S

VP Sales &Purchasing

X

S

P

S

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P

S

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S

8.2.3 Review ofrequirements
related to products
and services
8.2.4 Changes torequirements for
products andservices
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P

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8.3.2.2 - Productdesign skills

X

8.3.2.3 Development of
Products with
Embedded
SoftwareX

8.3.3.1 - Product
Design Input

X

8.3.3.2 Manufacturing
Process Design
Input

Engineering
ManagerX

8.3.5 - Design andDevelopment
Outputs
8.3.5.2 Manufacturing
process design
output
8.4 Control ofexternally provided
processes,
products/services

P

S

S

S

S

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S

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S

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Engineering
ManagerXS

VP Sales &Purchasing

XS

8.5.1 Control ofproduction andservice provision

Top Management

8.5.1.5 - Total
Productive
Maintenance

MaintenanceManagerX

8.5.1.6 Management of
Production
Tooling,Engineering
Manager

X

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Manufacturing,
Test, Inspection
Tooling andEquipment
8.5.2 Identificationand traceability

Assist. QC
Manager

8.5.3 Property
belonging tocustomers or
external providers

VP Sales &Purchasing

8.5.4 Preservation

Assist. QC
Manager

8.5.5 Post-delivery
activities

VP Sales &Purchasing

8.5.6 Control ofchanges including
design 8.3.6

Engineering
Manager

8.6 Release of
products andservices

Assist. QC
Manager

8.7 - Control ofnonconforming
outputs

Assist. QC
ManagerXS

8.7.1.2 - Control of
Non-Conforming
Outputs

Assist. QC
ManagerX

8.7.1.4 - Control ofReworkAssist. QC
Manager

X

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9.1.1 Monitoringand measurement- General

Assist. QC
ManagerS

9.1.2 Customer
satisfaction

VP Sales &PurchasingS

9.1.3 Analysis andevaluation

Top ManagementP

9.2 Internal audit

Assist. QC
ManagerXS

9.3 Management
review

Top Management

XP

10.1 Improvement- General

Top Management

10.2
Nonconformity andcorrective action

Assist. QC
ManagerX

10.2.4 - Error
Proofing

Engineering
ManagerX

10.3 Continual
improvement

Engineering
Manager

X

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S

S

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P - Primary
Responsibility
S - Secondary
Responsibility
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4.4

Quality Management System and Its Processes

4.4.1

General Requirements

PML, Inc. shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance withthe requirements of this International Standard. The organization shall determine the processes
required, their application throughout the organization and shall:a. Determine the inputs required and the outputs expected from these processes;
b. Determine the sequence and interaction of these processes;
c. Determine and apply the criteria and methods (including monitoring, measurements andrelated performance indicators) needed to ensure the effective operation and control ofthese processes;
d. Determine the resources needed for these processes and ensure their availability;e. Assign the responsibilities and authorities for these processes;
f. Address risks and opportunities as determined in accordance with the requirements ofSection 6.1, andg. Evaluate the processes and implement any changes needed to ensure these processes
achieve their intended results and are continually improved.

4.4.1.1

Conformance of Products and Processes.

It is the responsibility of each PML, Inc. associate to ensure that all products and services
conform to the specified customer requirements, including service parts and those that areoutsourced, and to ensure that all statutory and regulatory requirements are adhered to.

4.4.1.2

Product Safety

PML, Inc. has documented processes for the management of product-safety related products andmanufacturing processes. These processes are identified in the Product Safety Management
Level II Procedure.

4.4.2

General Requirements

The quality system manual, referenced procedures, work instructions and records of evidencecomprise PML, Inc.’s quality system. The quality system manual covers the requirements of theInternational standards; ISO9001:2015 and IATF16949:2016. The structure of the quality system
is as follows:• Level 1 - Quality Systems Manual• Level 2 - Procedures• Level 3 - Work Instructions and Process Instructions• Level 4 – Records (Reports, Tags, Miscellaneous Documents)

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Section V: Leadership and Commitment
5.0

Leadership5.1

Leadership and Commitment

5.1.1

GeneralPML, Inc.’s top management shall provide evidence of its commitment and accountability to thedevelopment and implementation of the quality management system and continually improving
its effectiveness and efficiency by:a.
Ensuring the context and strategic direction of PML, Inc. is determined andcommunicated to the relevant interested parties;b.
Communicating to all associates the importance of meeting customer and legal
requirements;c.
Establishing and communicating the quality policy and quality objectives;d.
Conducting management reviews;
e.
Ensuring the availability of resources through the business planning process;f.
Promote the use of process approach and risk-based thinking, andg.
Supporting relevant management roles to demonstrate and reinforce their leadership as
it applies to their areas of responsibility.

5.1.1.1

Corporate Responsibility

PML, Inc. realizes that to be a successful company, all associates must be forthright, honest andfair in their dealings with all interested parties whether customers, suppliers, workforce, local
community, etc. To ensure such conduct it will:a. Communicate that bribery, of any type or amount, is strictly forbidden;b. Provide a PML associate handbook to all associates that communicates all rules andpolicies of PML, Inc. The handbook is available via the PML, Inc. website and by hard
copy, if desired;c. Communicate to all associates the method for communicating a violation of any code of
conduct and that there will be no disciplinary action taken for communicating a goodfaith belief that a violation has occurred;d. PML, Inc. will always make our associates safety our number one priority in any and allactivities that are pursued, ande. PML, Inc. will always treat our associates with respect and dignity.

5.1.1.2

Process Effectiveness and Efficiency

Top management will the key process indicators of all product realization processes and support
processes to ensure their effectiveness and efficiency.

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Process Owners

Top management shall identify process owners, whether product realization or support, andcommunicate responsibilities and goals targeted for each process. To ensure this is effectively
accomplished, PML, Inc. will do the following:a. The management structure shall be documented and communicated by use of anorganizational chart;b. Ensure responsibilities are communicated through job descriptions, andc. Ensuring competency by determining and documenting the successful completion of therequired education, experience and or training.

5.1.2

Customer Focus

Top management will ensure that customer and legal requirements are determined and achieved
with the aim of enhancing customer satisfaction. These requirements are communicated by the
PML, Inc. sales department throughout the organization. Multidisciplinary teams meet regularly
to review customer requirements, determine risks and opportunities and ensure customer
satisfaction is enhanced.

5.2

Quality Policy

5.2.1

Establishing the Quality Policy

Through quarterly plant meetings, as well as scheduled management review meetings, PML,
Inc.’s top management will ensure that the quality policy:
a. Is appropriate to the purpose of PML, Inc.;
b. Includes a commitment to comply with requirements and continually improve theeffectiveness of the quality management system;c. Provides a framework for establishing and reviewing quality objectives;
d. Is communicated and understood within PML, Inc., ande. Is reviewed for continuing suitability.

5.2.2

Communicating the Quality Policy

To ensure proper communication is achieved, PML, Inc will:a. Inform associates of the quality policy during their orientation with the human resource
department;b. Post signs throughout the facility stating the quality policy, andc. Ensure communication of the quality policy to all relevant interested parties.

PML Inc.’s quality policy is to provide our customers defect-free
products, on time, at a competitive price with a commitment tocontinuous quality improvement.
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Organization Roles, Responsibilities and Authorities

Top management has defined responsibilities and authorities. These are communicated throughorganizational charts, Section II of the quality manual, and through job descriptions for each job
function. Each process owner will report the results and opportunities of their specific areas
during quarterly management reviews, daily QCD meetings, etc. to top management. PML, Inc.
will ensure the integrity of the QMS is maintained when changes are planned and implemented.

5.3.1

Organization Roles, Responsibilities and Authorities –Supplemental

Top management has designated the Quality Manager and the responsible process owner as theindividuals with the responsibility and authority to ensure that customer requirements are
addressed. This includes selection of special characteristics, setting quality objectives, related
training, corrective and preventive actions, product development, capacity analysis, logistics
information, customer scorecards, customer portals and process design and development.

5.3.2

Responsibility and Authority for ProductRequirements and Corrective Actions.

Managers with responsibility and authority for corrective action will be promptly informed ofproducts or processes which do not conform to requirements. All associates are responsible for
product quality and have the authority to stop production to correct quality problems.
Production operations across all shifts are staffed with personnel in charge of, or delegatedresponsibility for, ensuring product quality and stopping shipment, if required. See Corrective
Action Level II Procedure.

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Section VI: Planning
6.1

Actions to Address Risk and Opportunities

6.1.1 & 6.1.2 General Information
Planning for the quality management system and business plans are carried out by the following
steps:
a. Consideration is given to the external and internal issues identified in 4.1 and the needs
and expectations of the interested parties identified in 4.2;
b. Analysis of competitive products and benchmarking inside and outside the rubber
industry is conducted, when possible;
c. All managers contribute experience, information and suggestions to the development of
the business plan and improving the quality management system;d. Customer performance is analyzed based on trends in current sales, future forecasts,
potential opportunities for new business; quality performance, delivery performance andother critical KPI’s;e. Determine the required actions to ensure the successful completion of the required quality
management system outputs;
f. Opportunities and risks are identified to enhance the performance of the quality
management system. Resources are determined and allocated based on the potential
impact of the identified risks and opportunities. These data also drive preventive action
activities. (Refer to Preventive Action Level II Procedure)g. Actions are determined to reduce defect, waste and other undesirable outcomes;
h. Effectiveness and efficiency are monitored on a regular basis and actions taken based onthese results, andi. A strategic business plan is developed that includes 1- year and 3 - year projections.

6.1.2.1

Risk Analysis

PML, Inc. will document evidence of risk analysis for lessons learned from:a. Product recalls;b. Product audits;c. Field returns and repairs;d. Interested party complaints;
e. Excessive overtime;f. Turnover;g. Premium freight;
h. Accidents;
i. Scrap,
j. Rework, andk. Other information as required.

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Preventive Action

PML, Inc. will determine action to eliminate the causes of potential nonconformities in order toprevent their occurrence. Preventive actions are appropriate for the effects of the potential
problems.
PML, Inc. has a documented procedure titled Preventive Action Level II Procedure, which
defines the requirements for:a. Determining potential nonconformities and their causes;
b. Evaluating the need for action to prevent occurrence of nonconformities;
c. Determining and implementing action(s) needed;
d. Records of actions taken and results;
e. Reviewing the effectiveness of the preventive action taken, andf. Utilizing lessons learned to prevent similar non-conformances in other processes.

6.1.2.3

Contingency Plans

PML, Inc. reviews reasonably foreseeable internal and external risks to all manufacturing
processes and infrastructure equipment that are essential to maintain production outputs and meetcustomer requirements. Contingency plans are documented and reviewed, at a minimum,
annually to protect and ensure the supply of product to the customer in the, at a minimum,
following events:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.

Interruption from externally provided products, processes and services;
Key equipment failures;
Reoccurring natural disasters;
Fire;
Utility interruptions;
Labor shortages;
Chemical spills;
Hazardous releases;
Infrastructure disruptions, andInformation technology equipment failures.

A notification process is in place to inform all relevant interested parties as to the extent andduration of the situation impacting customer operations. Periodic tests are conducted to test theeffectiveness of the contingency plans. If changes are made, a description of the change, why thechange occurred and the person authorizing the change shall be documented.
In the event of an unplanned stoppage of production, after re-start is accomplished, product will
be validated to ensure it meets customer requirements. This will be accomplished through the 1stpiece inspection process.

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Contingency Planning Acronym

E – List the events that could potentially interfere and or disrupt the ability to supply

products in the desired quantity or that could prevent the conformance with required
specifications whether internal, customer or governmental. Evaluate the impact of eachand assign resources based on the evaluation.

R – Focus on those events that could reasonably occur. For example, Paris, TN willprobably not suffer a volcanic eruption, however, the potential for tornadoes is high.

A – Develop a contingency action plan for the likely events. Determine what actions will be

Required, first, to ensure our associates are protected and then how PML, Inc. willcontinue to provide our customers defect free products on time. Remember, customer
communication is critical. They must be communicated with to ensure their understandingof the situation.

S – The plans will be simulated to test the effectiveness of the action plan.
E – Was the plan effective? Were the planned results achieved? If so, good. If not, go back andreformulate your action plan. Focus on those areas that fell short of the initial plan.
Prioritize and allocate the resources as efficiently as possible.

P–D–C–A

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6.2

Quality Objectives & Planning to Achieve Them

6.2.1

General Information

PML will make quality objectives at relevant functions, levels and processes needed for quality
management system. The quality objectives shall:a. Be consistent with the quality policy;b. Be measurable;c. Consider applicable requirements;
d. Be relevant to conformity of products and services and to the enhancement of customer
satisfaction;e. Be monitored;
f. Be communicated;
g. Be updated as appropriate.
The organization shall maintain documented information on the quality objectives.

6.2.2

General Information

When PML is planning how to achieve its quality objectives it shall determine:a. What will be done;b. What resources will be required;c. Who will be responsible;
d. When it will be completed;e. How the results will be evaluated

6.2.2.1

Quality Objectives & Planning to Achieve
Them - Supplemental

PML’s top management shall ensure that quality objectives to meet customer requirements aredefined, established, and maintained for relevant functions, processes, and levels throughout theorganization.
The results of PML’s review regarding interested parties and the relevant requirements shall beconsidered when it establishes its annual quality objectives and related performance targets.

6.3

Planning of Changes

Required changes will be controlled, planned and PML shall consider:a. The purpose of the changes and potential consequences;b. The integrity of the quality management system;c. The availability of resources;
d. The allocation or re-allocation of responsibilities and authorities.
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Section VII - Support
7.1

Resources

7.1.1

GeneralWhen determining the required resources to implement, maintain and continually improve thequality management system, PML, Inc. will analyze the following:a. The capabilities and constraints of internal resources, andb. The resources required from external providers.
Successful completion of the above will strengthen PML, Inc.’s ability to enhance customer
satisfaction.

7.1.2

PeoplePML, Inc. shall determine and provide the necessary people to ensure the effective
implementation of the quality management system and for the operation and control of its
processes.

7.1.3

Infrastructure

PML, Inc. determines, provides and maintains the infrastructure needed to achieve conformity to
product requirements. Infrastructure includes buildings, workspace, associated utilities, processequipment, hardware, software, transportation resources, information and communication
technology and supporting services.

7.1.3.1 Plant, Facility and Equipment Planning
PML, Inc. uses a multi-disciplinary team to develop facilities, processes, and equipment inconjunction with the advanced quality planning process. Consideration is given to risk
identification and mitigation methods including, but not limited to, the use of PFMEA’s. This
allows PML, Inc. to:a. Improve associate safety;
b. Optimize and synchronize material flow;c. Improve material handling;d. Increase the value-added use of existing floor space, ande. Improve control of non-conforming products.
When launching new products and processes, PML, Inc. shall, using advanced quality planningand lean manufacturing techniques, evaluate, develop and implement manufacturing feasibility
studies, including capacity planning. These methods shall also be used for evaluating changes
proposed to existing operations.
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PML, Inc. shall maintain process effectiveness, including periodic re-evaluation relative to risk,
to incorporate any changes made during process approval, control plan maintenance andverification of job set-ups. Assessments of manufacturing feasibility and evaluation of capacity
planning shall be inputs to management review.
The above methods shall apply to any on-site supplier of products and services.

7.1.4

Environment for the Operation of Processes

PML, Inc. recognizes the importance of a suitable environment for our associates. Consideration
will be given to:a. Ensuring a safe work environment for all associates;b. Ensuring discrimination does not occur;c. Promoting a non-confrontational work environment;
d. Reducing stress to the extent possible;
e. Burn out prevention;
f. Maintaining clean work areas;g. Reducing noise to the extent possible;
h. Ensuring light is available to the necessary levels, andi. Maintaining reasonable temperature control for all associates.

7.1.4.1

Environment for the Operation of Processes –Supplemental

PML, Inc. promotes an environment that is clean and in a state of order that is consistent with its
products and processes. It is the responsibility of each associate to maintain a clean and orderly
work area. By maintaining a clean and orderly environment we not only improve control of the
products and processes, but also more importantly increase the level of associate safety.

7.1.5

Monitoring and Measuring Resources

7.1.5.1

GeneralProper measuring resources are critical to ensure accurate product and process validation. To
ensure reliable results when measurements are taken, PML, Inc. shall:
a.
b.
c.
d.

Provide the proper resources including equipment and training;
Ensure suitability of the specific type of monitoring and measurement activities;
Promote the proper maintenance activities for continuing fitness, andRetain appropriate documentation as evidence of the fitness for the intended purpose.

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7.1.5.1.1 Measurement System Analysis

Appropriate statistical studies are conducted to analyze the variation present in the different
types of measurement systems used for monitoring special characteristics referenced in thecontrol plans. The analytical methods and acceptance criteria conform to the Measurement
Systems Analysis reference manual. Other methods and acceptance criteria may be used, if
approved by the customer, and additional documentation shall be maintained as evidence of theresults of the analysis and acceptance by the customer.

7.1.5.2

Measurement Traceability

When measurement traceability is a customer requirement or is considered by PML, Inc. to be an
essential part of providing confidence in the validity of measurement results, measuring
equipment shall be:a. Calibrated, verified or both;b. At specified intervals or prior to use against measurement system standards traceable
to international or national measurement standards;c. When no international or national standards exist, the basis used for calibration orverification shall be retained as documented information;
d. Identified to determine their status, ande. Safeguarded against adjustments, damage or deterioration that would invalidate thecalibration status and subsequent measurement results.
When measuring equipment is found to be unfit for its intended purpose and the validity ofprevious measurement results have been affected, PML, Inc. shall take the appropriate action
necessary.

7.1.5.2.1 Calibration/Verification Records
PML, Inc.’s calibration system is governed by the Calibration System Level II Procedure.
Records of calibration / verification activities for all gauges, measuring and test equipment,
including employee, customer and on-site supplier owned equipment are used to provide
evidence of conformity to internal requirements, legislative and regulatory requirements andcustomer defined requirements.
PML, Inc. shall ensure the activities and records include the following details:
a. Revisions following engineering changes that affect measurement systems;b. Any out of spec readings as received for calibration / verification;c. An assessment of risk of the intended use of the product caused by the out-specification
condition;d. When a piece of inspection measurement and test equipment is found to be out ofcalibration or defective during its planned verification or calibration or during its use,
documented information on the validity of previous measurement results obtained withthis piece of inspection measurement and test equipment shall be retained, including theassociated standard's last calibration date and the next due date on the calibration report;
e. Customer notification if suspect product or material has been shipped;
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g. Verification that the software version used for product and process control is as specified;h. Records of the calibration and maintenance activities for all gauging (including
employee-owned equipment, customer-owned equipment, or on-site supplier-owned
equipment);
i. Production-related software verification used for product and process control (including
software installed on employee-owned equipment, customer-owned equipment, or on-site
supplier-owned equipment).
j. Work instructions detail the process for the verification of measuring equipment.
Calibration records list the equipment description, unique identification, location,
frequency of checks, check method, acceptance criteria and standards used. The
Calibration System Level II Procedure explains the actions to be taken when results areunsatisfactory.

7.1.5.3

Laboratory Requirements

7.1.5.3.1 Internal Laboratory
PML, Inc.’s laboratory has a laboratory scope containing the following: (Reference Laboratory
Requirements Level II Procedure)a. The specific tests, evaluations and calibrations PML, Inc. has the ability andcompetency to perform.
b. A list of the equipment which it uses to perform the above.
c. A list of the testing methods and standards to which it performs the above.
Additionally, the laboratory documents all its policies, systems, programs, procedures,instructions and findings which enable the laboratory to assure the quality of the tests orcalibration results it generates within the scope, including those required by the customer.
Laboratory personnel making professional judgments with reference to testing and/or calibration
have appropriate background and experience.
PML, Inc.’s laboratory has documented procedures for the receipt, identification, handling,protection and retention or disposal of test samples and/or calibration equipment items, including
all provisions necessary to protect the integrity of the items. Items are retained until final data iscomplete throughout the life of the item in the laboratory.
PML, Inc.’s laboratory monitors, controls and records environmental conditions when requiredby relevant specifications or where they influence the quality of results. Requirements are
established and maintained as appropriate to the technical activities concerned.
PML, Inc.’s laboratory uses test and /or calibration methods, including those for sampling, whichmeet the needs of the customer and are appropriate for the tests and/or calibrations it undertakes,
and they are traceable to the relevant process standard. Before carrying out any such work, thelaboratory verifies its capability to perform to the standard specifications. When it is necessary toemploy methods not covered by standard specifications, the customer is notified.
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Statistical techniques are applied to verification activities whose deliverables are data. Records
are reviewed as required.

7.1.5.3.2 External Laboratory
External/commercial/independent laboratory facilities used for inspection, test or calibration
services by PML, Inc. will have a defined laboratory scope that includes the capability toperform the required inspection, test or calibration. There will be evidence that the external
laboratory is acceptable to PML, Inc. and its customer or the laboratory will be accredited to
ISO/IEC 17025 or national equivalent.

7.1.6

Organizational Knowledge

PML, Inc. determines and documents the knowledge necessary for the operation and control of
its process to ensure product and service conformity by:a. Addressing changing knowledge needs and trends;
b. Comparing current knowledge base to future knowledge requirements;c. Updating knowledge through OJT;
d. Utilizing seminars, periodicals, scholastic and other external training resources;e. Promoting open communication between all associates to share information, andf. Promoting involvement in meetings, for example QCD, Quarterly Management meetings,
associate meetings, etc., so information can be shared.

7.2

Competence

PML, Inc. will:a. Determine the necessary competence for personnel performing work affecting productquality;b. Provide training or take other actions to satisfy these needs;c. Evaluate the effectiveness of the actions taken, andd. Maintain appropriate records of education, training, skills and experience.

7.2.1

Competence – Supplemental

PML, Inc. has established and maintains a documented procedure identifying training needs andachieving competence of all personnel performing activities affecting product quality.
Associates performing specific assigned tasks are qualified, as required, with attention to thesatisfaction of customer requirements.

7.2.2

Competence – On-The-Job-Training

PML, Inc. provides on the job training for associates in any new or modified job, customer
required training, internal required training or legislative requirements affecting product quality,
including contract or agency personnel. Associates whose work can affect quality are informed
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about the consequences to the customer of nonconformity to quality requirements. The level ofdetail of on-the-job-training shall be commensurate based on the level of education the personnel
possess and the complexity of the task required to be performed. (Refer to Training Level II
Procedure)

7.2.3

Internal Auditor Competency

PML, Inc. has a documented process to verify that internal auditors are competent including any
customer specific requirements. The organization shall maintain a list of qualified internal
auditors. (Refer to Internal & Second Party Auditor Competency Level II Procedure)
Quality management system, manufacturing process and product auditors shall be able todemonstrate the competence in:a. The automotive process approach for auditing, including risk-based thinking;b. Applicable customer-specific requirements;c. ISO9001:2015, IATF16949:2016 and other required requirements related to the scope of
the audit;
d. Applicable core tool requirements related to the scope of the audit;e. How to plan, conduct, report, and close out audit findings;
f. The technical understanding of the relevant manufacturing process(es) to be audited,
including process risk analysis (such as PFMEA) and control plan methodology, andg. Product requirements and use of relevant measuring and test equipment to verify productconformity.
Where training is provided, documented information shall be retained. Maintenance of andimprovement in internal auditor competence shall be demonstrated through:a. Executing a minimum of 5 audits per year; andb. Maintaining knowledge of relevant requirements based on internal and externalrequirements.

7.2.4

Second-Party Auditor Competency

PML, Inc. shall determine the competence of the auditors undertaking the second-party audits.
Second-party auditors shall meet customer specific requirements for auditor qualification anddemonstrate the following core competencies, including understanding of:a. The automotive process approach to auditing, including risk-based thinking;b. Applicable customer and organization specific requirements;c. Applicable ISO9001:2015 and IATF16949:2016 requirements related to the scope of theaudit;
d. Applicable manufacturing process(es) to be audited, including PFMEA and control plan;e. Applicable core tool requirements related to the scope of the audit,f. How to plan, conduct, prepare audit reports, and close out audit findings.

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Awareness

PML, Inc. shall ensure that persons doing work under its control are aware of the following
points:a. Required safe work procedures and personal protective equipment;b. The quality policy;c. Relevant quality objectives;d. Their contribution to the effectiveness of the quality management system, including thebenefits of improved performance, ande. The implications of not conforming with the quality management system requirements.

7.3.1

Awareness – Supplemental

PML, Inc. maintains documented training information demonstrating that all employees areaware of their impact on product quality and the importance of their activities in achieving,
maintaining, and improving quality, including customer requirements and the risks involved for
PML, Inc. and the customer with nonconforming product(s).

7.3.2

Employee Motivation and Empowerment

PML, Inc. has a process to motivate its associates to achieve quality objectives, make continual
improvements and create an innovative environment. The process promotes quality andtechnological awareness throughout the whole company. Some of the motivational techniques
used are as follows:
a. QCDS Performance Vacation Day;b. Monthly treat/recognition if PML, Inc.’s number of quality claims and PPM targets aremet for that particular month;c. Safety incentive days;
d. Safety Lotto;e. Perfect Attendance – awarded quarterly;
f. QCDS Performance Bonus – Quarterly;g. OEE performance results, andh. IATF16949 / ISO9001 / ISO14001 Audit Performance Luncheons.

7.4

Communication

Top management ensures that appropriate communication processes are established within PML,
Inc. and that communication takes place regarding the effectiveness of the quality management
system. Internal communication includes, but is not limited to, the following activities:
a. Quarterly management meetings – process owners report on key performance indicators.
b. Quarterly associate meetings – updates by top management may include performanceindicators, customer updates, policy changes / reinforcement, etc.
c. PML, Inc. newsletter – documented information that focuses on select areas. Generally
written by department managers.
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etc.

7.5

Documented Information

7.5.1

GeneralThe quality system manual, referenced procedures, work instructions and records of evidencecomprise PML, Inc.’s quality system. The quality system manual encompasses the requirementsof ISO9001:2015 and IATF16949:2016. The structure of the quality system is outlined below:
a. Level 1 - Quality Systems Manualb. Level 2 - Proceduresc. Level 3 - Work Instructions and Process Instructions
d. Level 4 – Records (Reports, Tags, Miscellaneous Documents)

7.5.1.1

Quality Management System Documentation

Documented procedures covering the requirements of IATF16949:2016, PML, Inc.’s quality
policy and procedures and customer standards define the quality system. A controlled numberingsystem governs all documentation.
The procedures and instructions effectively implement the quality system policies. Work
instructions explain how to perform an operation and support system procedures that document
the activity, including responsibilities and timing.

7.5.2

Creating and Updating

When documentation is created or updated, PML, Inc. shall ensure:a. Proper identification and description, including title, date, author, reference number, etc.;b. Proper format and media, andc. Review and approval for suitability and adequacy.

7.5.3

Control of Documented Information

7.5.3.1

General Requirements

PML, Inc. maintains documented procedures for the identification, distribution, retrieval, access,storage, maintenance and disposition of records. This is summarized in the
Quality/Environmental Record Retention Level II Procedure.
Quality records are maintained to demonstrate conformance to specified requirements and theeffective operation of the quality system. Pertinent subcontractor quality records are included in
the retention and maintenance.
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The records are legible, stored in a suitable environment to prevent damage or deterioration andare readily retrievable. Electronic data is backed-up and stored. Quality records are madeavailable to the customer or the customer’s representative when agreed to contractually.

7.5.3.2

General Requirements – Continued

PML, Inc. has established procedures to control documents required by the quality management
system. Customer drawings, standards, documents and data supporting the quality system arereviewed and approved by authorized personnel before issue. Master lists identifying the current
revision status of all procedures, work and process instructions, and customer drawings aremaintained.
Obsolete documents are promptly removed from all points of issue including operating locations.
Obsolete documents are destroyed or identified as “Obsolete” if retained for reference, to assure
against unintended use. Where appropriate, electronic media is immediately replaced with
updates upon reissue.
Reference the following procedures: System Documentation and Drawing and Standard
Control Level II Procedures.
These documents will ensure the following:a. Approved for adequacy prior to use;b. Accessed, used and retrieved properly;c. Reviewed and updated as necessary and re-approved;d. Revision status of documents are identified;e. Relevant versions of applicable documents are available at points of use;
f. Documents remain legible and readily identifiable;
g. Required documents of external origin are identified and their distribution controlled,andh. The unintended use of obsolete documents is prevented.

7.5.3.2.1 Record Retention
Reference the System Documentation Level II Procedure for retention times by record type.
Customer specific retention periods are adhered to as contractually required, if not specified bycustomer the minimum retention time will be the length of time the part is active for production
and service requirements plus one calendar year. Documents from superseded parts required for
new part qualification are retained in the new part file. The control of records shall satisfy all
customer, organizational, statutory and regulatory requirements.

7.5.3.2.2 Engineering Specifications
Customer engineering standards, specifications and changes that affect the product or process arereviewed per the Drawing and Standard Control Level II Procedure to assure the review,
distribution and implementation within ten business days. Implementation includes updates to all
appropriate documents.
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Section VIII - Operations
8.0

Operation

8.1

Operational Planning and Control

PML, Inc. plans and develops the processes needed for product realization. Planning of productrealization is consistent with the requirements of the other processes of the quality management
system. In planning product realization, PML, Inc. determines the following:a. Quality objectives and requirements for the product;b. The need to establish processes, documents, controls and provide resources specific to
the product;c. Required verification, validation, monitoring, inspection and test activities specific to
the product and the criteria for product acceptance;d. Records needed to provide evidence that the realization processes and resulting productmeet requirements;
e. Ensure planning outputs suitable for operations;f. Proper control of planned changes;
g. Proper review and mitigation of consequences of unintended changes, andh. Proper control of outsourced processes.

8.1.1

Operational Planning and Control - Supplemental

PML, Inc. shall use the APQP process for product realization project planning. At a minimum,
the following points will be covered:a. Customer products and technical specifications;b. Logistics requirements;c. Manufacturing feasibility;d. Process design, including lean manufacturing techniques;e. Acceptance criteria, andf. Project planning.

8.1.2

Confidentiality

PML, Inc. will ensure confidentiality of customer-contracted products and projects underdevelopment, and related product information.

8.2

Requirements for Products and Services

8.2.1

Customer Communication

PML, Inc. utilizes several methods of communicating with the customer. These include, but are
not limited to, APQP, PPAP, purchase orders, request for quote, 8-D reports, phone calls, email,
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faxes, letters, and face-to-face meetings. These methods will be used to effectively communicate
with our customers in relation to:a. Product information;b. Inquiries, contracts or order handling, including amendments;
c. Customer feedback, including customer complaints;
d. Handling or controlling customer property, ande. Establishing specific requirements for contingency requirements, when relevant.
The Vice-President of Sales/Purchasing has the final responsibility for resolving differences
between PML, INC. and the customer.

8.2.1.1

Customer Communication – Supplemental

PML, Inc. can communicate necessary information, including data, in a customer-specified
language and format. Examples include, but are not limited to: computer-aided design data
(Catia), electronic data exchange, email, internet, etc.

8.2.2

Determining Requirements for Products and Services

PML, Inc. is responsible for determining the following items related to the product:a. Requirements specified by the customer, including the requirements for delivery andpost-delivery activities
b. Requirements not stated by the customer, but necessary for specified or intended use,
where known;c. Statutory and regulatory requirements related to the product, andd. Any additional requirements determined by PML, Inc.
This will be accomplished through effective communications with the customer.

8.2.2.1

Determining Requirements for Products and Services– Supplemental

These requirements shall include recycling, environmental impact, and characteristics identified
as a result of the organization's knowledge of the product and manufacturing processes. These
shall include but not be limited to the following:a. All applicable government, safety, and environmental regulations related to acquisition,
storage, handling, recycling, elimination, or disposal of material.

8.2.3

Review of the Requirements for Products and Services

8.2.3.1

GeneralPML, Inc. sales department initiates a feasibility study for proposed products prior to contracting
to produce them. This review is documented using the Feasibility Review Form and is inaccordance with the Customer Quote Review Level II Procedure.
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The review shall ensure that:a. Product requirements are defined;b. Contract or order requirements different from those previously expressed are resolved;c. That PML, Inc. has the ability to meet the defined requirements, andd. All Statutory or regulatory requirements applicable to the products and services.
The review will be recorded utilizing the feasibility form. This completed form, with all
appropriate signatures, is kept in the part file. Where the customer provides no documented
statement of requirement, the customer requirements are confirmed by the sales department priorto acceptance.
When product requirements are changed, PML, Inc. will ensure that relevant documents areamended and that relevant personnel are made aware of the changed requirements. PML, Inc.
requires customer authorization to process a contract amendment. Sales/Customer Service is thecustomer liaison. They institute the amendment process, depending on the extent of theamendment, per the Order Review Level II Procedure.
The Sales/Customer Service function maintains records of quotation and purchase order reviews
for their respective departments per System Documentation Level II Procedure.

8.2.3.1.1 Review of the Requirements for Products andServices – Supplemental
Waiver of the review mandated in 8.2.3.1 requires a documented customer authorization.

8.2.3.1.2 Customer-Designated Special Characteristics
Special characteristics are those characteristics identified on inspection standards, set-up
manuals, etc. These characteristics have been identified by PML, Inc. to be the key
characteristics in controlling product conformity. In the event a special characteristic is identified
by the customer, PML, Inc. will conform to the requirements for designation, approval
documentation and control as set forth by the customer. Special characteristics are identified
during part feasibility analysis and APQP activities.

8.2.3.1.3 Organization Manufacturing Feasibility
PML, Inc. investigates, confirms and documents the manufacturing feasibility of the proposed
products in the contract review process, including risk analysis. This is documented on the PML,
Inc. feasibility review form, FSE-001.
The sales department manages the feasibility review form which requires input frommanufacturing, quality assurance, engineering, sales, and material engineering to assess thefeasibility of a part to fit within PML, Inc.’s production capabilities.
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PML, Inc. will validate utilizing production runs, benchmarking studies or other appropriate
methods to ensure its ability to make product to the required specifications and at the requiredrate.

8.2.3.2 Organization Manufacturing Feasibility –Supplemental
PML, Inc. shall retain documented evidence reflecting the results of the review and on any new
requirements for products and services.

8.2.4

Changes to Requirements for Products and Services

When product requirements are changed, PML, Inc. will ensure relevant documents are amended
and relevant personnel are made aware of the changed requirements. PML, Inc. requires
customer authorization to process a contract amendment. Sales/Customer Service is the customer
liaison. They will institute the amendment process, depending on the extent of the amendment,
per the Order Review Level II Procedure.

8.3

Design and Development of Products and Services

8.3.1

GeneralPML, Inc. shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services. PML, Inc. is not productdesign responsible, but is responsible for process design.

8.3.1.1

Design and Development of Products and Services –Supplemental

PML, Inc. does not design products. The material engineering group, supported by Marugo
Rubber Industries, assists in the development of compounds to meet customer specifications.
PML, Inc. will plan and control its processes to meet customer-designed product requirements.
The APQP and PPAP processes are used to meet the standards required and emphasis shall beplaced on error prevention. The design and development process is documented.
(Refer Manufacturing Process Design Level II Procedure)

8.3.2

Design and Development Planning

PML, Inc. uses a multidisciplinary approach to prepare for product realization. The APQP
program consists of an internal cross-functional team that defines and documents how the quality
requirements will be met and prepares the production of new or changed products. The APQPteam uses appropriate techniques identified in the Advanced Product Quality Planning and PPAP
reference manuals.
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The activities include as appropriate:a. Development/finalization and monitoring of special characteristics;
b. Development and review of FMEA’s, including actions to reduce potential risks;c. Development and review of control plans;d. The nature, duration and complexity of the design and development activities;e. The required process stages, including applicable design and development reviews;
f. The required design and development verification and validation activities;
g. The responsibilities and authorities involved in the design and development process;h. The internal and external resource needs for the design and development of products andservices;i. The need to control interfaces between persons involved in the design and development
process;
j. The need for involvement of customers and users in the design and development process;k. The requirements for subsequent provision of products and services;l. The level of control expected for the design and development process by customers and otherrelevant interested parties, andm. The documented information needed to demonstrate the design and development
requirements have been met.

8.3.2.1

Design and Development Planning – Supplemental

PML, Inc. shall plan APQP activities to include all interested parties, within the organization,and the supply chain, when applicable. PFMEA’s, control plans, work instructions, etc. shall becreated and reviewed during the design and development of manufacturing processes.

8.3.2.2

Product Design Skills

PML, Inc. is not responsible for product design, therefore there are no personnel with productdesign responsibility.

8.3.2.3

Development of Products with Embedded Software

PML, Inc. does not produce products or provide services with embedded software requirements.

8.3.3

Design and Development Inputs

Where appropriate, PML, Inc. will record:a. Functional and performance requirements;
b. Applicable statutory and regulatory requirements;c. Where applicable, information derived from previous similar designs and development
activities;
d. Standard or codes of practice that PML, Inc. has committed to implement;e. Potential consequences of failure due to the nature of the products and services;
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8.3.3.1

Product Design Input

Not applicable to PML, Inc.

8.3.3.2

Manufacturing Process Design Input

PML, Inc. will identify, document and review the manufacturing process design input
requirements, including:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.

Product design output data, including special characteristics;
Targets for productivity, process capability, timing and cost;
Alternative processes are not available in PML, Inc.;
Customer requirements, if any;
Experience from previous developments;
New materials;
Product material handling;
Safety points including, but limited to, PPE, ergonomics, etc.;
Design manufacturing and assembly, andError proofing appropriate for the potential risk and process requirements.
(Refer Manufacturing Process Design Level II Procedure)

8.3.3

Special Characteristics

Special characteristics are those characteristics identified on inspection standards, set-up
manuals, etc. These characteristics have been identified by PML, Inc., using multi-disciplinary
teams and risk analysis, to be the key characteristics in controlling product conformity. In theevent a special characteristic is identified by the customer, PML, Inc. will conform to therequirements for designation, approval documentation and control as set forth by the customer. A
matrix is used to denote the customers’ special characteristic symbol and the corresponding
PML, Inc. symbol. Special characteristic key:a.

Regarding safety:b.

Regarding Regulation:c.

Special characteristics other than a and b:

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8.3.4

Design and Development Controls

PML, Inc. shall apply controls to the design and development process, through the use of multidisciplinary teams, APQP and PPAP, to ensure:a. Process and product targets are defined;b. Periodic reviews are conducted to evaluate the ability of the results development to meetrequirements;c. Activities are verified to ensure that the design and development outputs meet the input
requirements;d. Activities are verified to ensure that the design and development outputs meet the input
requirements;
e. Validation is conducted to ensure that the resulting products and services meet therequirements for the specified application or intended use;
f. Necessary actions are taken on problems determined during the reviews, or verificationand validation activities, andg. Documented information of these activities is retained in the customer PPAP packages
and APQP records.

8.3.4.1

Monitoring

Measurements at specified stages of design and development are defined and analyzed during
APQP activities. Summary results are discussed during management review meetings. Whenappropriate, these measurements may include quality risks, cost, lead times, critical paths andother measurements.

8.3.4.2

Design and Development Validation

Design and development validation will be performed in accordance with:a. Customer requirements including program timing, andb. Applicable governmental regulatory and industry standards.

8.3.4.3

Prototype Program

When required by the customer, PML, Inc. will have a prototype program and control plan. We
will, whenever possible, use the same suppliers, tooling and manufacturing processes as will be
used in production.
All performance-testing activities shall be monitored for timely completion and conformity torequirements. When services are outsourced, the organization shall include the type and extent ofcontrol in the scope of its quality management system to ensure that outsourced services conformto requirements.

8.3.4.4
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PML, Inc. has a product approval process (PPAP) recognized by our customers. Productapproval is subsequent to the verification of the manufacturing process. The product andmanufacturing process approval procedure is also applied to suppliers, where appropriate.
PML, Inc. shall approve externally provided products and services, per ISO9001:2015 Section
8.4.3, prior to submission of part approval to customer. If required by the customer, PML, Inc.
will obtain documented product approval prior to shipment. Records of such approval shall be
required and properly retained.

8.3.5

Design and Development Outputs

The outputs of process design and development will be provided in a form that enables
verification against the process design and development inputs and will be approved prior torelease. These outputs will:a. Meet the input requirements for process design and development;b. Provide appropriate information for purchasing, production and for service provision;c. Contain or reference product acceptance criteria;d. Include monitoring and measurement requirements;e. Specify the characteristics of the product that are essential for its safe and proper use, andf. Retain documented information on design and development outputs.

8.3.5.1

Design and Development Outputs – Supplemental

PML, Inc. is not design responsible. This section is non-applicable.

8.3.5.2

Manufacturing Process Design Output

The manufacturing process design outputs will be expressed in terms that can be verified against
manufacturing process design input requirements and validated. The manufacturing process
design output shall include:a. Specifications and drawings;
b. Special characteristics for product and manufacturing processes;c. Identification of input variables that impact characteristics;
d. Tooling and equipment for production and control, including capability studies ofequipment and processes;
e. Manufacturing process flow charts / layouts, including linkage of product, process andtooling;
f. Capacity analysis;g. Process FMEA’s;h. Maintenance plans and instructions;i. Control plans;j. Standard work and work instructions;k. Process approval acceptance criteria;
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m. Results of error-proofing validation and identification activities, as appropriate, andn. Methods of rapid detection, feedback and correction of product/manufacturing process
nonconformities.

8.3.6

Design and Development Changes

Design and development changes shall be:a. Identified and records maintained;
b. Reviewed, verified and validated;c. Approved before implementation, if required, andd. Evaluated for the effects of the changes on constituent parts and product alreadydelivered, if required.
Records retained include:a. Design and development changes;
b. Results of reviews;
c. Authorization of the changes, andd. Actions taken to prevent adverse impacts.
(Refer to Control of Changes Level II Procedures)

8.3.6.1

Design and Development Changes – Supplemental

PML, Inc. has measures in place to control and react to changes impacting the productrealization process. The effects of any change, including those changes caused by suppliers, areassessed, verified and validated. The activities shall be defined to ensure compliance withcustomer requirements. Changes are validated prior to implementation through the use ofstatistical techniques, where applicable.
For proprietary designs, impact on form, fit and function are reviewed with the customer so that
all effects can be properly evaluated.
When required by the customer, additional verification/validation requirements, such as thoserequired for new product introduction, will be performed. Any product realization change
affecting customer requirements requires customer notification and approval. These requirements
apply to product and manufacturing process changes. Customer approvals via the PPAP process
are required.

8.4

Control of Externally Provided Processes, Products
and Services

8.4.1

General

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PML, Inc. shall ensure that externally provided processes, products and services conform to its
and the customer requirements. PML, Inc. shall determine the controls to be applied to externallyprovided processes, products and services when:a. Products and services from external providers are intended for incorporation into theorganization's own products and services;b. Products and services are provided directly to the customer(s) by external providers onbehalf of the organization, andc. A process, or part of a process, is provided by an external provider as a result of adecision by the organization.
The organization shall determine and apply the required criteria for the evaluation, selection,
monitoring of performance, and re-evaluation of external providers, based on their ability toprovide processes or products and services in accordance with requirements. The organization
shall retain documented information of these activities and any necessary actions arising fromthe evaluations.

8.4.1.1 General - Supplemental
PML, Inc. shall include all products and services that affect customer requirements such as
subassembly, sequencing, sorting, rework, and calibration services in the scope of their definitionof externally provided products, processes, and services.

8.4.1.2 Supplier Selection Process
PML, Inc. has a documented supplier selection process. The process includes:a. An assessment of the selected supplier's risk to product conformity and uninterrupted
supply of the organization's product to their customers;b. Quality performance;c. Delivery performance;d. An evaluation of the supplier's quality management system;e. Multidisciplinary decision making; andf. An assessment of software development capabilities, if applicable.
Other criteria, depending on supplier and or products provided, may include:a. Volume of automotive business (absolute and as a percentage of total business);b. Financial stability;c. Purchased product, material, or service complexity;
d. Required technology (product or process);
e. Adequacy of available resources (e.g., people, infrastructure);f. Design and development capabilities (including project management);
g. Manufacturing capability;h. Change management process;i. Business continuity planning (e.g., disaster preparedness, contingency planning);
j. Logistics process, andk. Customer service.
(Refer to Purchasing Level II Procedure)
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8.4.1.3 Customer-Directed Sources (Directed-Buy)
When required by the customer, PML, Inc. shall purchase products, materials, or services from
customer-directed sources. All requirements of IATF16949:2016 Section 8.4, except for 8.4.1.2,
are applicable to the control of customer-directed sources, unless specific agreements areotherwise contractually defined between PML, Inc. and the customer.

8.4.2

Type and Extent of Control

PML, Inc. shall ensure that externally provided processes, products and services do not adversely
affect the organization's ability to consistently deliver conforming products and services to its
customers.
PML, Inc. shall:a. Ensure externally provided processes remain within the control of its quality management
system, andb. Define the controls that it intends to apply to an external provider and those it intends toapply to the resulting output.
Consideration will be given to:a. The potential impact of the externally provided processes, products and services on theorganization's ability to consistently meet customer and applicable statutory andregulatory requirements;b. The effectiveness of the controls applied by the external provider, andc. Determine the verification, or other activities, necessary to ensure that the externallyprovided processes, products and services meet requirements.

8.4.2.1 Type and Extent of Control – Supplemental
PML, Inc. has a documented process to identify outsourced processes and to select the types andextent of controls used to verify conformity of externally provided products, processes, andservices to internal and external customer requirements.
The process includes criteria and actions for escalation or reduction of the types and extent ofcontrols and development activities based on supplier performance and assessment of product,
material, or service risks.

8.4.2.2 Statutory or Regulatory Requirements
All materials used in the manufacturing of products will be reviewed by either purchasing ormaterial engineering to ensure they satisfy current governmental and safety constraints on
restricted, toxic and hazardous materials. This includes environmental, electrical andelectromagnetic considerations applicable to the country of manufacture, the country of receipt,
the country of shipment, and the customer-identified country of destination, if provided. If thecustomer defines special controls for certain products with statutory and regulatory requirements,
the organization shall ensure they are implemented and maintained as defined, including at the
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purchase orders.

8.4.2.3 Supplier Quality Management System Development
PML, Inc. requires suppliers of automotive products and services to develop, implement, andimprove a quality management system certified to ISO9001:2015, unless otherwise authorized
by the customer, with the ultimate objective of becoming certified to IATF16949:2016. Unlessotherwise specified by the customer, the following sequence should be applied to achieve thisrequirement:a. Compliance to ISO9001:2015 through second-party audits;
b. Certification to ISO9001:2015 through third-party audits; unless otherwise specified by
the customer, suppliers to the organization shall demonstrate conformity to
ISO9001:2015 by maintaining a third-party certification issued by a certification body
bearing the accreditation mark of a recognized IAF MLA (International Accreditation
Forum Multilateral Recognition Arrangement) member and where the accreditation
body's main scope includes management system certification to ISO/IEC 17021;
c. Certification to ISO9001:2015 with compliance to other customer-defined QMS
requirements (such as Minimum Automotive Quality Management System Requirements
for Sub-Tier Suppliers [MAQMSR] or equivalent) through second-party audits;
d. Certification to ISO9001:2015 with compliance to IATF16949:2016 through secondparty audits;
e. Certification to IATF16949:2016 through third-party audits (valid third-party
certification of the supplier to IATF16949:2016 by an IATF-recognized certificationbody).

8.4.2.3.1 Automotive Product-Related Software or
Automotive Products with Embedded Software
Not applicable.

8.4.2.4

Supplier Monitoring

Supplier performance will be monitored and documented. The following indicators will bemonitored.
a. Delivered product quality;
b. Customer disruptions including field returns;
c. Delivery schedule performance (including incidents of premium freight);
d. Special status customer notifications related to quality or delivery issues, ande. Dealer returns, warranty, field actions and recalls.
(Refer to the Purchasing Level II Procedure)

8.4.2.4.1 Second-Party Audits
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PML, Inc. includes a second-party audit process in their supplier management approach. Secondparty audits may be used for the following:a. Supplier risk assessment;b. Supplier monitoring;c. Supplier QMS development;
d. Product audits, ande. Process audits.
Based on risk analysis, including product safety/regulatory requirements, performance of the
supplier, and QMS certification level, at a minimum, the organization shall document the criteria
for determining the need, type, frequency, and scope of second-party audits.
Records and reports of second-party audits are retained. If the scope of the second-party audit is
to assess the supplier's quality management system, then the approach shall be consistent withthe automotive process approach.

8.4.2.5

Supplier Development

The organization shall determine the priority, type, extent, and timing of required supplierdevelopment actions for its active suppliers.
Determination inputs shall include but are not limited to the following:a. Performance issues identified through supplier monitoring. (Section 8.4.2.4);
b. Second-party audit findings (Section 8.4.2.4.1);
c. Third-party quality management system certification status, andd. Risk analysis.
Actions necessary to resolve open (unsatisfactory) performance issues will be implemented andPML, Inc. will pursue opportunities for continual improvement.

8.4.3

Information for External Providers

PML, Inc. shall ensure the adequacy of requirements prior to their communication to the external
provider.
Requirements for the following will be supplied to the provider:a. The processes, products and services to be provided;b. The approval of products and services, methods, processes and equipment and the releaseof products and services;c. Competence, including any required qualification of persons;d. The external providers' interactions with the organization;e. Control and monitoring of the external providers' performance to be applied by theorganization, andf. Verification or validation activities that the organization, or its customer, intends toperform at the external providers' premises.

8.4.3.1 Information for External Providers – Supplemental
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PML, Inc.’s Purchasing department communicates all applicable statutory and regulatory
requirements and special product and process characteristics to their suppliers and requires the
suppliers to cascade all applicable requirements down the supply chain to the point of
manufacture.

8.5

Production and Service Provision

8.5.1

Control of Production and Service Provision

PML, Inc. will plan and carry out production and service provision under controlled conditions.
Controlled conditions include, as applicable:
a. The availability of information that describes the characteristics of the product and theresults achieved;b. The availability of work instructions, as necessary;c. The use of suitable equipment;
d. The use of suitable infrastructure and environment for the operation of processes;e. The appointment of competent persons, including any required qualifications;f. The availability and use of monitoring and measuring devices;g. The validation, and periodic re-evaluation, of the ability to achieve planned results of theprocesses for production and service prevision, where the resulting output cannot be
verified by subsequent, monitoring and measurement;h. Human error-proofing;i. The implementation of monitoring and measurement, andj. The implementation of release, delivery and post-delivery activities.

8.5.1.1

Control Plan

PML, Inc. develops control plans at all levels appropriate for the product supplied. PML shallhave a control plan for pre-launch and production that shows linkage and incorporates
information form the design risk analysis (if provided by the customer), process flow diagram,and manufacturing process risk analysis outputs (such as FMEA). The control plans aredeveloped using a multi-disciplinary approach. The control plans will include:a. The controls used for the manufacturing process control;b. First-off/last-off part validation;c. Methods for monitoring of control exercised over special characteristics defined by boththe customer and the organization;d. Customer-required information, if any, ande. The specified reaction plan when the process becomes unstable or not statisticallycapable.
The quality department is responsible for ensuring that control plans are reviewed and updated at
a set frequency based on risk analysis or when any change occurs affecting product,
manufacturing process, measurement, logistics, supply sources, production volume changes,
customer complaints, after corrective actions, or FMEA’s. If required by the customer, PML willobtain customer approval after review or revision of the control plan.
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8.5.1.2

Standardize Work-Operator Instructions and VisualStandards

PML, Inc. shall ensure that standardized work instructions are:a. Communicated and understood by the associates who are responsible for
performing the work;b. Legible;
c. Include rules for operator safety;d. Presented in the language(s) understood by the personnel responsible to follow them, ande. Accessible for use at the designated work area(s).

8.5.1.3

Verification of Job Set-Ups

PML, Inc. shall:a. Verify job set-ups when performed, such as an initial run of a job, materialchangeover, or job change that requires a new set-up;
b. Maintain documented information for set-up personnel;c.

Use statistical methods of verification, where applicable;

Perform first-off/last-off part validation, as applicable, first-off parts should be
retained for comparison with the last-off parts. Where appropriate, last-off-parts
should be retained for comparison with first-off parts in subsequent runs, ande. Retain records of process and product approval following set-up and firstoff/last-off part validations.
d.

8.5.1.4 Verification after Shutdown
PML, Inc. shall define and implement the necessary actions to ensure product compliance withrequirements after planned or unplanned production shutdown period.

8.5.1.5 Total Productive Maintenance
PML, Inc. shall develop, implement, and maintain a documented total productive maintenancesystem.
At a minimum, the system shall include the following:a. Identification of process equipment necessary to produce conforming
product at the required volume;
b. Availability of replacement parts for the equipment identified in item a);c. Provision of resource for machine, equipment, and facility maintenance;d. Packaging and preservation of equipment, tooling, and gauging;
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f. Documented maintenance objectives

g. Regular review of maintenance plan and objectives and a documented
action plan to address corrective actions where objectives are not achieved;h. Use of preventive maintenance methods;
i. Use of predictive maintenance methods, as applicable, andj. Periodic overhaul.
(Refer to Maintenance Management Level II Procedure)

8.5.1.6 Management of Production Tooling andManufacturing, Test, Inspection Tooling andEquipment
PML, Inc. shall provide resources for tool and gauge design, fabrication, and verification
activities for production and service materials and for bulk materials, as applicable.
PML, Inc. shall establish and implement a system for production tooling management, whether
owned by the organization or the customer, including:a. Maintenance and repair facilities and personnel;b. Storage and recovery;c. Set-up;
d. Tool-change programs for perishable tools;e. Tool design modification documentation, including engineering change level of the
product;
f. Tool modification and revision to documentation;
g. Tool identification, such as serial or asset number;h. The status, such as production, repair or disposal;
i. Ownership, andj. Location.
PML, Inc. shall verify that customer-owned tools, manufacturing equipment, and test/inspection
equipment are permanently marked in a visible location so that the ownership and application ofeach item can be determined.
PML, Inc. shall implement a system to monitor these activities if any work is outsourced.
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8.5.1.7

Production Scheduling

Production is scheduled in order to meet customer requirements, such as Just-In-Time (JIT) andis supported by an AS400 information system that permits access to production information at
key stages of the process and is order driven. PML, Inc. shall include relevant planning
information during production scheduling, e.g., customer orders, supplier-on-time delivery
performance, capacity, shared loading (multi-part station), lead time, inventory level,
preventative maintenance, and calibration.

8.5.2

Identification and Traceability

PML, Inc. identifies the product by suitable means throughout the product realization process.
The traceability program maintains identification of raw material from receipt, during all stagesof production, through to our customers. Product Identification and Traceability Level II
Procedure defines the traceability program activities.
PML, Inc. applies specific identification on the product or product container as required by thecustomer and shall retain documented information necessary to ensure traceability.

8.5.2.1 Identification and Traceability – Supplemental
PML, Inc. shall conduct an analysis on internal, customer and regulatory traceability
requirements for all automotive products, including developing and documenting traceability
plans, based on the levels of risk or failure severity for employees, customers, and consumers.
These plans shall define the appropriate traceability systems, processes, and methods by product,
process, and manufacturing location that:a. Enable the organization to identify nonconforming and/or suspect product;b. Enable the organization to segregate nonconforming and/or suspect product;c. Ensure the ability to meet the customer and/or regulatory response timerequirements;
d. Ensure documented information is retained in the format (electronic, hardcopy,archive) that enables the organization to meet the response time requirements;
e. Ensure serialized identification of individual products, if specified by the customer or
regulatory standards, andf. Ensure the identification and traceability requirements are extended to externallyprovided products with safety/regulatory characteristics.

8.5.3

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Providers

PML, Inc. verifies customer supplied material, tooling and packaging meet agreed upon
specifications. Safe storage and maintenance are provided for items supplied by the customer.
Any product that is lost, damaged or is otherwise unsuitable for use is recorded and reported tothe customer and other required interested parties. The customer has the responsibility toprovide PML, Inc. acceptable product that meets agreed upon specifications.

8.5.4

Preservation

PML, Inc. shall preserve the outputs during production and service provision, to the extent
necessary to ensure conformity to requirements. Preservation can include identification,
handling, contamination control, packaging, storage, transmission or transportation, andprotection.

8.5.4.1

Preservation – Supplemental

Preservation shall include identification, handling, contamination control, packaging, storage,transmission or transportation, and protection. Preservation shall apply to materials andcomponents from external and/or internal providers from receipt through processing, including
shipment and until delivery to/acceptance by the customer.
To detect deterioration, the organization shall assess at appropriate planned intervals thecondition of product in stock, the place/type of storage container, and the storage environment.
The organization shall use the FIFO inventory management system to optimize inventory turns
over time and ensure stock rotation.
Obsolete product is controlled in the same manner as that of nonconforming product.
Customer requirements for preservation, packaging, shipping, and labeling requirements shall becomplied with.

8.5.5

Post-Delivery Activities

PML, Inc. will meet requirements for post-delivery activities associated with the products andservices. We will determine the extent of post-delivery activities that are required and shallconsider the following:a. Statutory and regulatory requirements;b. Potential undesired consequences associated with our products and services;c. The nature, use and intended lifetime of our products and services;
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e. Customer feedback.

Post-delivery activities can include actions under warranty provisions, contractual obligations
such as maintenance services, and supplementary services such as recycling or final disposition.

8.5.5.1 Feedback of Information from Service
PML, Inc. shall ensure that a process for communication of information on service concerns to
manufacturing, material handling, logistics, engineering, and design activities is established,
implemented, and maintained.
PML, Inc. will be aware of non-conforming products and materials that may be identified at thecustomer or in the field.
"Service concerns" shall include the results of field failure test analysis.

8.5.5.2 Service Agreement with Customer
Not applicable to PML, Inc.

8.5.6

Control of Changes

PML, Inc. shall review and control changes for production or service provision, to ensure
continuing conformity with requirements. It will retain documented information describing theresults of the review of changes, the person authorizing the change, and any necessary actions
arising from the review.

8.5.6.1 Control of Changes – Supplemental
PML, Inc. shall have a documented process to control and react to changes that impact productrealization. The effect of all changes will be accessed by the following:a. Define verification and validation activities to ensure compliance with customer
requirements;b. Validated changes before implementation;c. Document evidence of related risk analysis, andd. Retain records of verification and validation.
All changes made will require a production trial run for verification of changes to validate theimpact of these changes on the manufacturing process. If required by the customer, PML, Inc.
will:
a. Notify the customer of any planned customer changes after the most recent productapproval;b. Obtain documented approval prior to implementation of the change, andc. Complete additional verification or identification requirements, such as production trial
run and new production validation.
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PML, Inc.
Quality Assurance Manual(Refer to Control of Changes Level II Procedure)

8.5.6.1.1 Temporary Change of Process Controls
If required, PML, Inc. will identify, document, and maintain a list of the process controls,
including inspection, measuring, tests, and error-proofing devices, that includes the primaryprocess control and the approved back-up or alternative methods. PML, Inc. will document theprocess that manages the use of alternative use methods. We will include in this process, basedon risk-analysis, severity and the internal approvals to be obtained prior to production
implementation of the alternate control method.
If required, we will obtain approval from our customer prior to shipping the product.
Work instructions shall be available for each alternative process control method. PML, Inc. will
review the operation of alternate process controls on a daily basis to verify standard work with agoal to return to the standard process as defined by the control plan as soon as possible.
PML, Inc. shall implement traceability of all product produced with any alternate process control
devices or processes.
Restart verification is documented for a defined period based on severity and confirmation that
all features of the error-proofing device or process are effectively reinstated. The 1st piece / lastpiece procedure will be followed.

8.6

Release of Products and Services

PML, Inc. shall implement planned arrangements, at appropriate stages to verify that the productand service requirements have been met. PML, Inc. shall retain documented information on therelease of products and services. The information shall include:a. Evidence of conformity, andb. Traceability to the person who authorized the release.
The release of products and services to the customer shall not proceed until the plannedarrangements have been satisfactorily completed, unless otherwise approved by a relevant
authority and, as applicable, by the customer.

8.6.1

Release of Products and Services – Supplemental

PML, Inc. has measures in place to control and react to changes impacting product realization.
The change effects, including those changes caused by suppliers, are assessed, verified andvalidated. Activities shall be defined to ensure compliance with customer requirements. Changes
are validated prior to implementation. This will be done through statistical techniques, whereapplicable.
For proprietary designs, impact on form, fit and function will be reviewed with the customer sothat all effects can be properly evaluated. When required by the customer, additional
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Quality Assurance Manualverification/identification requirements, such as those required for new product introduction, aremet. Any product realization change affecting customer requirements requires customer
notification and approval.

8.6.2 Layout Inspection and Functional Testing
A layout inspection and functional verification to applicable customer engineering, material andperformance standards will be performed for each product as specified in the control plans.
Results will be available for customer review.
••

Layout inspection is a complete measurement of all product dimensions shown on the design record.
The frequency of layout inspection is determined by the customer.

8.6.3 Appearance Items“Appearance Items” are not designated by the customers at this time. If appearance items aredesignated by the customer PML, Inc. will do the following:a.
Provide appropriate resources including lighting for evaluation;b. Provide masters for color, grain, gloss, metallic brilliance, texture, distinctness ofimage, and haptic technology as appropriate;c.
Maintenance and control of appearance masters and evaluation equipment, andd.
Verification that associates are trained to make appearance evaluations in a competentmanner.

8.6.4 Verification and Acceptance of Conformity ofExternally Provided Products and Services
PML, Inc.’s incoming quality system uses one or more of the following methods, as specified on
the receiving inspection instructions, to assure conformance of externally provided products andservices:
a. Receipt of statistical data and evaluation;
b. Receiving inspection or testing (sampling based on performance);c. Second or third-party assessments or audits of the subcontractor locations;d. Evaluations by accredited contractors or test laboratory, ande. Another method agreed with the customer.
The controlling procedures for receiving inspection and test are Incoming Material
Control/Accelerated, Incoming Material Control/Master Batches, and Receiving Inspection ofNon- Rubber Materials Level II Procedures.

8.6.5

Statutory and Regulatory Conformity

Prior to release of externally provided products into its production flow, the organization shallconfirm and be able to provide evidence that externally provided processes, products, andservices conform to the latest applicable statutory, regulatory, and other requirements in the
countries where they are manufactured and the customer-identified countries of destination, if
provided.
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Acceptance Criteria

PML, Inc. has defined acceptance criteria and, where required, the customer has approved them.
For attribute data sampling, the acceptance level is zero defects. (refer to 9.1.1.1)

8.7

Control of Non-Conforming Outputs

8.7.1

GeneralPML, Inc. will ensure outputs not conforming to requirements are identified and controlled toprevent their unintended use or delivery. It will deal with non-conforming outputs in one or moreof the following ways:
a. Correction
b. Segregation, containment, return or suspension of provision of products and services;c. Informing the customer, and or
d. Obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when non-conforming outputs are corrected.

8.7.1.1 Customer Authorization for Concession
PML, Inc. will obtain a customer concession or deviation permit prior to further processing
whenever the product or manufacturing process is different from that which is currently
approved.
PML, shall obtain customer authorization prior to further processing for “use as is” and rework
dispositions of non-conforming products. If sub-components are re-used in the manufacturing
process, it will be clearly communicated to the customer in the concession of deviation permit.
PML, Inc. will maintain a record of the expiration date or quantity authorized. It will ensurecompliance with the original or superseding specifications and requirements when theauthorization expires. Material shipped on an authorization will be properly identified on eachshipping container.
This applies equally to purchased product. PML, Inc. will agree with any requests fromsuppliers before submission to the customer.

8.7.1.2 Control of Nonconforming Product – CustomerSpecified Process
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PML, Inc. shall comply with applicable customer-specified controls for nonconforming products.

8.7.1.3 Control of Suspect Product
PML, Inc. shall ensure that all product with unidentified or suspect status is controlled as
nonconforming product. It will ensure all associates receive training for containment of suspect
and nonconforming product.

8.7.1.4 Control of Rework ProductProduct may be reprocessed per standard process procedures and work instructions. Rework
instructions are utilized by the appropriate personnel and are accessible at their workstations.
Reference the Rework, Sort, Reject Level II Procedure.
Repaired or reworked product is re-inspected according to the inspection or laboratory
instructions and/or control plan.
PML, Inc. shall utilize risk analysis such as FMEA to assess risks in the rework process prior to
reworking the product. Customer approval will be obtained, if required, prior to reworking
products. PML, Inc. will retain documented information on the disposition of reworked productincluding quantity, disposition, disposition date, and applicable traceability information.

8.7.1.5 Control of Repaired ProductCurrently PML, Inc. does not repair product. If in the future we must repair product, we will:a. Assess risks in the repair process;b. Obtain approval from the customer before beginning the repair
make a documented process for repair in accordance to the control planor other documented information;c. Make work instructions for disassembly or repair, including re-inspection
and traceability requirements;
d. Obtain a documented customer authorization for concession for the
product to be repaired, ande. Retain documented information on the disposition of repaired productincluding quantity, disposition, disposition date, and applicabletraceability information.

8.7.1.6

Customer Notification

PML, Inc. shall immediately notify the customer in the event that non-conforming product has
been shipped. Initial communication will be followed with detailed documentation of the event.

8.7.1.7
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PML, Inc. shall have a documented process for disposition of nonconforming product that is not
subject to rework. PML, Inc. will not divert nonconforming product to service or other use
without prior customer approval. All nonconforming product is placed in a red reject bucket. The
red reject buckets are emptied into the trash containers and the trash containers are emptied in to
the trash trailer. When full, this trailer is taken to the landfill for disposal by means ofincineration or burial.

8.7.2

GeneralPML, Inc. will retain documented information that:a. Describes the nonconformity;b. Describes the actions taken;c. Describes any concessions obtained, andd. Identifies the authority deciding the action is respect of the nonconformity.

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Section IX – Performance Evaluation
9.0

Performance Evaluation

9.1

Monitoring, Measurement, Analysis and Evaluation

9.1.1

GeneralPML, Inc. plans and implements the monitoring, measurement, analysis and improvement
processes needed:a. To demonstrate conformity to product requirements;
b. To ensure conformity of the quality management system;c. To continually improve the effectiveness of the quality management system.
d. To verify that the process flow diagram PFEMA and control plan are implemented, ande. To ensure adherence to measurement techniques, sampling plans, acceptance criteria,
proper measurement data records, and reaction plans and the escalation process, whencriteria are not met.
PML, Inc. controls the application of statistical techniques and the implementation of corrective
action indicated by the techniques. Proper documentation shall be retained.

9.1.1.1 Monitoring and Measurement of Manufacturing
Processes
PML, Inc. shall perform process studies on all new manufacturing processes to verify processcapability and to provide additional input for process control, including those for special
characteristics.
PML, Inc. will maintain manufacturing process capability or performance results as specified by
the customer's part approval process requirements. The organization shall verify that the process
flow diagram, PFMEA, and control plan are implemented, including adherence to the following:a. Measurement techniques;b. Sampling plans;c. Acceptance criteria;
d. Records of actual measurement values and/or test results for variable data;
e. Reaction plans and escalation process when acceptance criteria are not met.
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Quality Assurance ManualSignificant process events, such as tool change or machine repair, shall be recorded and retained
as documented information.
PML, Inc. shall initiate a reaction plan indicated on the control plan and evaluated for impact oncompliance to specifications for characteristics that are either not statistically capable or are
unstable. 100% inspection will be required when processes are not stable.
A corrective action plan shall be developed and implemented by the organization indicating
specific actions, timing, and assigned responsibilities to ensure that the process becomes stable
and statistically capable. The plans are reviewed with and approved by the customer, whenrequired. The organization shall maintain records of effective dates of process changes.

9.1.1.2

Identification of Statistical Tools

Appropriate statistical tools for each process are determined during the APQP process andincluded in the control plan and PFMEA, when applicable.

9.1.1.3

Application of Statistical Concepts

Basic statistical concepts, such as variation, control (stability), process capability and overadjustment are understood and utilized throughout the organization.

9.1.2

Customer Satisfaction

PML, Inc. receives reports from many customers showing our performance on areas such as
quality rating, cost, and delivery. Additionally, our sales department measures customer
satisfaction and perception by noting the level of satisfaction the customer communicated during
the sales visit on their sales report. This report is copied to various departments within PML toensure the customer’s views are understood.

9.1.2.1

Customer Satisfaction – Supplemental

Customer satisfaction is monitored by continual performance evaluation of the productrealization process. Performance indicators are based on objective data and include, but are notlimited to:a. Delivered part quality performance;
b. Customer disruptions including field returns;
c. Field returns, recalls, and warranty data;
d. Delivery schedule performance (including incidents of premium freight), ande. Customer notifications related to quality or delivery issues.
PML, Inc. monitors the performance of manufacturing processes to demonstrate compliance withcustomer requirements for product quality and efficiency of the process.

9.1.3
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PML, Inc. will determine, collect and analyze appropriate data demonstrating the suitability andeffectiveness of the quality management system and evaluate where continual improvement of
the effectiveness of the quality management system can be made. This will include data
generated by monitoring and measurement from other relevant sources.
The analysis of data shall provide information relating to:
a.
b.
c.
d.
e.
f.
g.

Customer satisfaction;
Evaluate the performance and effectiveness of the quality management system;
To determine if planning has been implemented effectively;
To determine the effectiveness of actions taken to reduce risks and opportunities;
To determine the need for improvements to the quality management system;
Conformity to product requirements;
Characteristics and trends of processes and products including opportunities forpreventive action, andh. Supplier performance.
(Refer to Continuous Improvement Level II Procedure)

9.1.3.1 Prioritization
Trends in quality and operational performance will be compared with progress toward objectives
and lead to action to support the following:
a.
b.
c.

Development of priorities for prompt solutions to customer-related problems;
Determination of key customer-related trends and correlation for status review,
decision-making and longer-term planning, andAn information system for the timely reporting of product information arising fromusage.

When available, data will be compared with those of competitors and/or an appropriate
benchmark.

9.2

Internal Audit

9.2.1 & 9.2.2 General Requirements
Internal quality audits verify whether quality activities comply with planned arrangements anddetermine the effectiveness of the quality system. PML, Inc. maintains documented proceduresfor planning and implementing internal quality audits. Reference the procedure, Quality System
Audit/Environmental System Audi Level II Procedure.
Internal audits are performed by team members who do not have direct responsibility for the area
being audited. Audits are scheduled based on status, importance of the activity and to comply
with the required frequencies mandated.

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Audit teams record and present audit results to personnel responsible for the area audited.
Management personnel for the audited area are required to determine the root cause, take timely
corrective action, and verify the implementation and effectiveness of actions taken on any
deficiencies found during the audit. Records are maintained from each audit. Auditors verify andrecord the implementation and effectiveness of the corrective actions taken.

9.2.2.1

Internal Audit Program

Internal auditing covers all shifts, processes and activities and is conducted according to an audit
schedule updated annually. When internal/external non-conformances, customer complaints,
process changes and other risks are identified, the priorities of the program will be adjusted.
Auditors will preserve adequate evidence to justify decisions concerning whether the process
audited is effective and efficient. Evidence will include, where applicable, control plans,
PFMEA’s, documents, quality objectives and performance to the quality objectives, specificcustomer requirements, etc.
The effectiveness and efficiency of the internal audit program will be reviewed in Management
Review.

9.2.2.2

Quality Management System Audit

PML, Inc. will audit its quality management system to verify compliance with the
IATF16949:2016 and any additional quality management system requirements, including
customer specific requirements. All management system processes will be audited, no less than,once every 3 years. When required, customer specific audit approaches will be used. will bereflected in the program.

9.2.2.3

Manufacturing Process Audit

PML, Inc. will audit each manufacturing process to determine its effectiveness and efficiency.
When required, PML, Inc. will use customer specific approaches for these audits. Each shift will
be audited where the process occurs, including shift change. Specific items to be audited include,
but are not limited to training, cleanliness and orderliness, documents, measurement systems,
PFMEA’s, control plans, and calibrations. Each process will be audited, at a minimum, once per
3 years. Control plans and PFMEA’s will be retained as evidence and a decision documented as
to whether they were or were not effectively implemented in the process.

9.2.2.4

Product Audit

PML, Inc. conducts audits of packaged final product to verify conformance to customer specified
requirements at an appropriate frequency. Depending on customer required PPM performance,
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will be used.

9.3

Management Review

9.3.1

GeneralManagement review meetings are conducted at defined intervals to determine adequacy,
effectiveness and continuing suitability of the quality system to satisfy the requirements of
IATF16949:2016, customer requirements and PML, Inc.’s stated quality policy and objectives.
This review includes the need for changes to the quality management system, including thequality policy and quality objectives.

9.3.1.1 Management Review – Supplemental
This review includes all requirements of the quality management system and its performancetrends as an essential part of the continual improvement process. Management reviews will beheld at a minimum, annually. When the performance of the QMS dictates reviews will be
increased.
Part of the management review will be the monitoring of the quality objectives, and the regular
reporting and evaluation of the cost of poor-quality. These results are recorded to provide, aT aminimum, evidence of the achievement of:a. The quality objectives specified in the business plan, andb. Customer satisfaction with product supplied

9.3.2 Management Review Inputs
The input to management reviews will include information on:
a. Results of audits;b. Customer feedback and satisfaction;c. Process performance and product conformity;d. Status of non-conformities and preventive and corrective actions;e. Follow-up actions from previous management reviews;
f. Changes, whether internal or external, that could affect the quality management system;
g. Recommendations for improvement;
h. The extent to which quality objectives have been met;
i. The performance of external providers;j. The adequacy of resources;
k. Monitoring and measuring results;
l. The effectiveness of actions taken to address risks and opportunities, andm. Opportunities for improvement

9.3.2.1
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Additional inputs are as follows:a. Cost of poor-quality;b. Measures of process effectiveness;c. Measures of process efficiency;d. Product conformance;e. Assessments of manufacturing feasibility made for changes to existing operations andfor new facilities or new products;
f. Customer satisfaction;
g. Review of performance against maintenance objectives;
h. Warranty performance;
i. Review of customer scorecards;
j. Identification of potential field failures identified through risk analysis, andk. Actual field failures and their impact on safety or the environment

9.3.3

Management Review Outputs

The output from the management review will be documented and include any decisions andactions related to:a. Improvement of the effectiveness of the quality management system and its processes;
b. Changes required for the QMS;
c. Improvement of product related to customer requirements, andd. Required resources.

9.3.3.1

Management Review Outputs – Supplemental

Action plans shall be developed and documented when customer performance targets are notmet.
(Refer Management Review Level II Procedure)

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Section X - Improvement
10.0

Improvement

10.1

GeneralPML, Inc. shall determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.
Consideration shall be given to:a. Associate safety;b. Defect reduction;c. Productivity increases;
d. VE/VA activities;
e. New technologies;
f. Corrective actions;g. Preventive actions,h. Other improvement activities.
PML, Inc. associates are encouraged to contribute ideas for continual improvement through thesuggestion box located in the manufacturing facility. Additionally, associates may be membersof kaizen teams offering continuous improvement ideas.

10.2

Nonconformity and Corrective Action

10.2.1 & 10.2.2 - General Information
Documented procedures prevent the unintentional use or shipment of product that does notconform to specified requirements. Questionable product is identified and segregated, whenpractical, in the nonconforming area. Product is evaluated, disposition made, and the findings
documented. Findings are presented to involved functions and management for assessment.
Reference Nonconforming Material Control Level II Procedure.
Documented procedures ensure that suspect as well as nonconforming material or product is notunintentionally used or shipped. If suspect and or non-conforming product is shipped to thecustomer, the customer will be informed, and a determination will be made of the actual impact
to the customer and actions taken to address the consequences.
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Nonconforming or suspect material or product and any quarantine areas are visually identified.
The Quality Manager is assigned the responsibilities for controlling nonconforming product.
Documented procedures define the inspection, testing and handling of suspect andnonconforming material and product.
PML, Inc. dispositions material or product as:a. Accepted, meets specified requirements;b. Reprocessed, to meet the specified requirements;c. Re-graded for alternate application, if the alternate application specified is met;d. Repaired with concession, customer authorization is required;e. Rejected or scrapped.
The need for action will be evaluated to eliminate causes of the non-conformances in order toprevent further occurrence. Actions will include:a. Reviewing nonconformities (including customer complaints);
b. Determining the causes of nonconformities;
c. Determining whether similar non-conformances exist or could potentially occur;d. Determining and implementing action needed;e. Records of the results of action taken;
f. Reviewing corrective action taken;
g. Update risks and opportunities determined during planning, if required, andh. Make required changes to the QMS, if required.
Corrective actions will be appropriate to the effects of the non-conformities encountered.
PML, Inc. effects action to eliminate the cause of nonconformities to prevent recurrence. Actions
and results will be documented. (refer to Corrective Action Level II Procedure)

10.2.3

Problem Solving

PML, Inc. has a documented process for problem solving that includes:a. Defined approaches for various types and scales of problems (e.g., new productdevelopment, current manufacturing issues, field failures, audit findings);
b. Containment, interim actions, and related activities necessary for control ofnonconforming outputs (see Section 8.7);
c. Root cause analysis, methodology used, analysis, and results;
d. Implementation of systemic corrective actions, including consideration of the impact onsimilar processes and products;
e. Verification of the effectiveness of implemented corrective actions;f. Reviewing and, where necessary, updating the appropriate documented information (e.g.,
PFMEA. control plan).
When required, PML, Inc. shall use customer specified techniques.

10.2.4 Error Proofing
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PML, Inc. has a documented process to determine the use of appropriate error-proofing
methodologies. Details of the method used shall be documented in the process risk analysis (suchas PFMEA) and test frequencies are documented in the control plan.
Challenge parts are used, where applicable, to test the function of the devices. Records of pass or
fail are maintained. Where possible, challenge parts, are identified, controlled, verified, andcalibrated. Reaction plans are in place in the event error-proofing devices are found tofunctioning improperly.
(Refer to Manufacturing Process Design Level II Procedure)

10.2.5 Warranty Management System

When PML, Inc. is required to provide warranty for their products, it shall implement a warranty
management process. There will be included a method for warranty part analysis, including NTF(no trouble found). When specified by the customer, PML, Inc. will implement the required
warranty management process.

10.2.6 Customer Complaints / Field Failure Test Analysis
PML, Inc. effectively analyzes product returned by the customer. Where appropriate, corrective
actions are initiated, and processes are changed to prevent recurrence. Findings from theanalysis, corrective actions and follow-up findings are recorded. The data is maintained and ismade available upon request.

10.3

Continuous Improvement

PML, Inc. will continually improve the effectiveness of the quality management system using
the quality policy, quality objectives, audit results, analysis of data, corrective and preventive
actions and management review.

10.3.1 Continual Improvement – Supplemental
PML, Inc has a documented process for continual improvement. The process includes:a. Identification of the methodology used, objectives, measurement, effectiveness, anddocumented information;
b. A manufacturing process improvement action plan with emphasis on the reduction ofprocess variation and waste; andc. Risk analysis (such as FMEA).
NOTE Continual improvement is implemented once manufacturing processes are statistically capable and stable
or when product characteristics are predictable and meet customer requirements.

(Refer to Continuous Improvement Level II Procedure)

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Level II Procedures:

HR.18.01 Training
ME.10.01 Incoming Material Control / Accelerated
ME.10.02 Incoming Material Control / Masterbatch
ME.10.06 Receiving Inspection of Non-Rubber Materials
ME.10.07 Laboratory Requirements
ME.10.08 IMDS Procedure
MG.01.02 Management Review
MG.02.01 Continuous Improvement
MT.09.02 Maintenance Management
PE.02.03 Tooling Management
PE.03.01 Control of Changes
PE.04.01 Manufacturing Process Design
PR.06.06 Purchasing Procedure
QC.05.05 System Documentation
QC.05.09 Drawing and Standard Control
QC.08.01 Product Identification and Traceability
QC.11.01 Calibration System
QC.13.01 Non-Conforming Material Control
QC.13.02 Rework, Sort, Reject Procedure
QC.14.01 Corrective Action
QC.14.02 Preventive Action
QC.17.01 Quality System Audit / Environmental System Audit
QC.21.01 Product Safety Management
QC.22.01 Internal and Second Party Auditor Competency
QC.23.01 Customer Supplier Manual Control
SL.03.01 Customer Quote Review
SL.03.02 Order Review Procedure

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