Production and Service Controls Process, Part 1 

CAPT Kimberly Lewandowski - Walker 

Senior Regulatory Officer 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Course Prerequisites

• Successful completion of the following MDSAP training 

module is a prerequisite to this course: 

– Introduction to the MDSAP Program 

– Overview of the MDSSAP Audit Process 

– MDSAP: Management Process 

– MDSAP: Measurement, Analysis and Improvement Process 

– Design and Development Process
Learning Objectives

• Explain the Production and Service Controls process 

• Describe the purpose of auditing the Production and Service 

Controls process 

• Discuss the expected outcomes from audit of the Production 

and Service Controls process 

• Explain the audit tasks for Production and Service Controls 

process, Part 1 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Learning Objectives

• Explain the Production and Service Controls process 

• Describe the purpose of auditing the Production and Service 

Controls process 

• Discuss the expected outcomes from audit of the Production 

and Service Controls process 

• Explain the audit tasks for Production and Service Controls 

process, Part 1 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Production and Service Controls process 

• The Production and Service Controls process: 

– Manufactures products that meet specifications by: 

ØDeveloping processes that are adequate to produce 

devices that meet specifications 

ØValidating (or fully verifying the results of) those 

processes 

ØMonitoring and controlling those processes
Production and Service Controls process

• Organization must understand when deviations could 

occur to meet the requirements of:

– Medical devices – Quality management systems – 

Requirements for regulatory purposes (ISO 13485:2016) 

– Quality Management System requirements of the Conformity 

Assessment Procedures of the Australian Therapeutic Goods 

(Medical Devices) Regulations (TG(MD)R Sch3) 

– Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
Production and Service Controls process

• Organization must understand when deviations could 

occur to meet the requirements of:

– Japan Ordinance on Standards for Manufacturing Control and 

Quality Control of Medical Devices and In Vitro Diagnostic 

Reagents (MHLW Ministerial Ordinance No. 169), 

– Quality System Regulation (21 CFR Part 820) 

– and specific requirements of medical device regulatory 

authorities participating in the MDSAP program
Role of the management representative

• The management representative: 

– Ensures that the requirements of the quality management 

system have been effectively defined, documented, 

implemented, and maintained 

– Interviewed to obtain an overview of the process and a feel 

for management's knowledge and understanding of the 

process
Learning Objectives

• Explain the Production and Service Controls process 

• Describe the purpose of auditing the Production and Service 

Controls process 

• Discuss the expected outcomes from audit of the Production 

and Service Controls process 

• Explain the audit tasks for Production and Service Controls 

process, Part 1 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
MDSAP Audit Sequence
Purpose of Auditing

• The Production and Service Controls process is audited 

to: 

– Verify that the manufacturer’s processes are capable of 

ensuring that products will meet specifications 

Øincludes testing, infrastructure, facilities, equipment, and 

servicing
Learning Objectives

• Explain the Production and Service Controls process 

• Describe the purpose of auditing the Production and Service 

Controls process 

• Discuss the expected outcomes from audit of the Production 

and Service Controls process 

• Explain the audit tasks for Production and Service Controls 

process, Part 1 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Expected Outcomes

As a result of the audit of the Production and Service Controls 

process, objective evidence will show whether the 

organization has: 

A. Defined, documented and implemented procedures to ensure 

production and service processes are planned, developed, 

conducted, controlled, and monitored to ensure conformity to 

specified requirements 

B. Developed production and service process controls commensurate 

with the potential effect of the process on product risk 
Expected Outcomes

As a result of the audit of the Production and Service Controls 

process, objective evidence will show whether the 

organization has: 

C. Ensured that when the results of a process cannot be verified by 

subsequent monitoring or measurement, the process is validated 

with a high degree of assurance to ensure that the process will 

consistently achieve the planned result 

D. Implemented procedures for the validation of the application of 

computer software for production and service processes that 

affect the ability of the product to conform to specified 

requirements, including validation of computer software used in 

the quality management system 
Expected Outcomes

As a result of the audit of the Production and Service Controls 

process, objective evidence will show whether the 

organization has: 

E. Maintained records for each batch of medical devices that 

provides information for traceability and confirmation that the 

batch meets specified requirements 

F. Implemented controls to protect customer property, including 

intellectual property, confidential health information, and other 

forms of customer property that is used or incorporated into 

products
Learning Objectives

• Explain the Production and Service Controls process 

• Describe the purpose of auditing the Production and Service 

Controls process 

• Discuss the expected outcomes from audit of the Production 

and Service Controls process 

• Explain the audit tasks for Production and Service Controls 

process, Part 1 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Task 1

1. Verify that the product realization processes are planned, including any 

necessary controls, controlled conditions, and risk management activities 

required for the product to meet the specified or intended uses, the 

statutory and regulatory requirements related to the product, and ( when 

applicable) unique device identifier requirements. Confirm that the 

planning of product realization is consistent with the requirements of the 

other processes of the quality management system and performed in 

consideration of the quality objectives. 

Clause and Regulation: [ISO 13485:2003: 7.1, 7.2.1, 7.5.1.1; TG(MD)R 

Sch 1 P1 2, Sch3 P1 Cl1.4(4), Sch3 P1 Cl1.4(5)(d)&(e); RDC ANVISA 

16/2013: 2.2.1, 2.4, 4.1.2, 4.1.7, 5.1; 21 CFR 820.30(b), 820.20(a), 

820.30(h), 820.70(a)] 

MDSAP Audit Approach
Task 1

• Additional country - specific requirements: United States (FDA) 

• Assessing conformity: 

– Be mindful of requirements: 

ØFor the product that relate to statutory and regulatory requirements 

ØNecessary for the product to meet specified requirements and intended 

uses 

ØFor safe and efficacious use of the product 

– Confirm that the organization has defined quality objectives for the 

device 

Detailed information on country - specific requirements and how to 

assess conformity for this audit task can be found in the MDSAP Audit 

Approach, Chapter 6: Production and Service Controls, under task 1 
Task 1

• Links: 

– Management 

ØConfirm that the quality objectives related to 

the product were considered for inclusion in 

management review
Task 2

2. Review production processes considering the following 

criteria. Select one or more production processes to 

audit. 

Clause and Regulation: None

MDSAP Audit Approach
Task 2

• Priority criteria for selection:

– Corrective and preventive action indicators of process problems or

potential problems

– Use of production process for higher risk products

– Use of production processes that directly impact the ability of the

device to meet its essential design outputs

– New production processes or new technologies

– Use of the process in manufacturing multiple products

– Processes that operate over multiple shifts

– Processes not covered during previous audits
Task 2

• Additional country - specific requirements: None

• Assessing conformity:

Detailed information on how to assess conformity for this audit

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 2 
Task 3

3. For each selected process, determine if the production and service 

process is planned and conducted under controlled conditions that 

include the following: 

– the availability of information describing product characteristics 

– the availability of documented procedures, requirements, work 

instructions, and reference materials, reference measurements, 

and criteria for workmanship 

– the use of suitable equipment 

– the availability and use of monitoring and measuring devices 

– the implementation of monitoring and measurement of process 

parameters and product characteristics during production 

MDSAP Audit Approach
Task 3

3. For each selected process, determine if the production and service

process is planned and conducted under controlled conditions that 

include the following (continued): 

– the implementation of release, delivery and post delivery

activities 

– the implementation of defined operations for labeling and

packaging

– the establishment of documented requirements for changes to

methods and processes 

Clause and Regulation: [ISO 13485:2016: 7.5.1, 8.2.5, 8.2.6; TG(MD)R 

Sch3 P1 Cl1.4(5)(d)&(e); RDC ANVISA 16/2013: 3.1.3, 4.2, 5.1, 5.2, 5.3, 

5.4, 5.6; 5.6.1; 5.6.2; MHLW MO169: 40, 57, 58, 59; 21 CFR 820.70(a), 

820.70(b), 820.75, 820.120, 820.130] 

MDSAP Audit Approach
Task 3

• Additional country - specific requirements: None 

• Assessing conformity:

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 3 
Task 4

4. Determine if the organization has established documented 

requirements for product cleanliness including any cleaning 

prior to sterilization, cleanliness requirements if provided 

non - sterile, and assuring that process agents are removed 

from the product if required. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 4.2.3, 6.4.2, 

7.5.2; TG(MD)R Sch3 P1 Cl1.4(5)(d); RDC ANVISA 16/2013: 

5.1.3.1, 5.1.3.4, 5.1.5.3; MHLW MO169: 6, 7 - 2, 25 - 2, 41 (Old: 6, 

25, 41); 21 CFR 820.70(c), 820.70(d), 820.70(e), 820.70(h)] 

MDSAP Audit Approach
Task 4

• Additional country - specific requirements: Brazil (ANVISA) 

• Assessing conformity: 

– Confirm identification of cleanliness requirements for the 

finished device and proper controls 

– Confirm effective arrangements to control the manufacturing 

materials commensurate with risk were made 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 4
Task 5

5. Verify that the organization has determined and documented 

the infrastructure requirements to achieve product 

conformity, including buildings, workspace, process 

equipment, and supporting services. Confirm that buildings, 

workspaces, and supporting services allow product to meet 

requirements. Verify that there are documented and 

implemented requirements for maintenance of process 

equipment, where important for product quality, and that 

records of maintenance are maintained.

Clause and Regulation: [ISO 13485:2016: 4.2.1, 6.3, 7.5.1; RDC 

ANVISA 16/2013: 5.1.2, 5.1.5; CMDR 14; MHLW MO169: 6, 24, 

40; 21 CFR 820.70(g), 820.70(f)] 

MDSAP Audit Approach
Task 5

• Additional country - specific requirements: Brazil (ANVISA) 

• Assessing conformity:

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 5 
Task 6

6. Verify documented requirements have been established, 

implemented and maintained for: 

– health, cleanliness, and clothing of personnel that could have an 

adverse effect on product quality 

– monitoring and controlling work environment conditions that 

can have an adverse effect on product quality 

– training or supervision of personnel who are required to work 

under special environmental conditions 

– controlling contaminated or potentially contaminated product 

(including returned products) in order to prevent contamination 

of other product, the work environment, or personnel 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 6.4; TG(MD)R Sch1 

P2 7.2, 8; RDC ANVISA 16/2013: 5.1.3; MHLW MO169: 6, 25 - 1, 25 - 2 

(Old: 6, 25); 21 CFR 820.70(c), 820.70(d), 820.70(e)] 

MDSAP Audit Approach
Task 6 

• Additional country - specific requirements: Brazil (ANVISA) 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 6. 
Task 7

7. Determine if the selected process(es) and sub - process(es) 

have been reviewed, including any outsourced processes, to 

determine if validation of these processes is required. 

Clause and Regulation: [ISO 13485:2016:4.2.1, 4.1.6, 7.5.6; 

TG(MD)R Sch1 P2 8.2, 8.3; Sch3 P1 1.4(5)(d), RDC 

ANVISA16/2013: 5.5.2, 5.5.3; MHLW MO169: 6, 5 - 6, 45 (Old: 6, 

45); 21 CFR 820.75(a)] 

MDSAP Audit Approach
Task 7

• Additional country - specific requirements: Brazil (ANVISA); 

and the United States (FDA) 

• Assessing conformity: 

– Confirm that the organization has identified processes which 

require validation 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 7 
Task 7

• Links: 

– Purchasing 

Ø Review the controls the organization has 

instituted over suppliers that perform validated 

processes 

ØLinkage can be particularly important for higher 

risk validated processes performed by suppliers
Task 8

8. Verify that the selected process(es) has been validated if the result 

of the process cannot be fully verified or can be verified, but is not. 

Confirm that the validation demonstrates the ability of the 

process(es) to consistently achieve the planned result. In the event 

changes have occurred to a previously validated process, confirm 

that the processes were reviewed and evaluated, and re - validation 

was performed where appropriate. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.5.6; TG(MD)R Sch1 

P1 2(1), Sch3 P1 1.4(5)(d); RDC ANVISA 16/2013: 1.2.18, 5.5.1; MHLW 

MO169: 6, 45; 21 CFR 820.75(a), 820.75(c)] 

MDSAP Audit Approach
Task 8

• Additional country - specific requirements: Australia (TGA) 

• Assessing conformity: 

– Determine when applicable whether: 

Ø The instruments used to generate the data were properly calibrated and 

maintained’ 

Ø Predetermined product and process specifications were established 

Ø Sampling plans used to collect test samples are based on a statistically valid 

rationale 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 8 
Task 9

9. If product is supplied sterile: (See Annex 2). 

– Verify the sterilization process is validated, periodically revalidated, and records of the validation are available 

– Verify that devices sold in a sterile state are manufactured 

and sterilized under appropriately controlled conditions 

– Determine if the sterilization process and results are 

documented and traceable to each batch of product

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.5.5, 7.5.6, 

7.5.7; TG(MD)R Sch1 2(1) & 8.3, Sch3 P1 1.4(5)(d); RDC ANVISA 

16/2013: 5.1.6, 5.5; CMDR 17; MHLW MO169: 6, 44, 45, 46; 21 

CFR 820.75, 820.184(d)] 

MDSAP Audit Approach
Task 9

• Additional country - specific requirements: Australia (TGA) 

• Assessing conformity: 

– Ensure cleaning, packaging, and sterilization processes are validated 

– Ensure organization maintains appropriate controls over: 

Ø Routine monitoring and measurement of the cleaning, packaging and sterilization processes 

Ø Routine acceptance criteria of the cleaning, packaging and sterilization processes 

Ø Requalification, reverification, recalibration and maintenance of the cleaning, packaging and 

sterilization equipment 

Detailed information how to assess conformity for this audit task can be 

found in the MDSAP Audit Approach, Chapter 6: Production and Service 

Controls, under task 9 
Task 10

10. Verify that the system for monitoring and measuring of

product characteristics is capable of demonstrating the 

conformity of products to specified requirements. Confirm

that product risk is considered in the type and extent of

product monitoring activities.

Clause and Regulation: [ISO 13485:2016: 7.1, 7.5.1, 8.1, 8.2.6;

TG(MD)R Sch1 P1 2, Sch3 P11.4(5)(b)&(e); RDC ANVISA 

16/2013: 2.4, 5.1.1, 9.1; MHLW MO169: 26, 40, 54, 58, 59; 21

CFR 820.70(a), 820.250(a)]

MDSAP Audit Approach
Task 10

• Additional country - specific requirements: None 

• Assessing conformity: 

– Confirm that the control measures are suitable for detecting 

process or product nonconformities 

Detailed information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 6: Production 

and Service Controls, under task 10 
Summary

• The Production and Service Controls process is 

intended to manufacture products that meet 

specifications 

• The organization must understand when deviations 

from device specifications could occur as a result of the 

production process or environment
Conclusion

• This concludes part 1 of the training module for MDSAP process: Production and 

Service Controls 

• Please move to part 2 to continue the discussion of the audit tasks for the Production 

and Service Controls process, as well as the links to other MDSAP processes