Production and Process Controls, Part 2: 

Acceptance Activities, Handling, Storage, 

Distribution, and Installation

Vidya Gopal

Consumer Safety Officer

Postmarket and Consumer Branch

Division of Industry and Consumer Education

Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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CDRH Learn: Production and Process Controls (Postmarket Activities)

fda.yorkcast.com/webcast/Play/c996037bfee443e4904ff2080833603a1d
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Learning Objectives

1. Review the purpose of the production and 

process controls subsystem

2. Describe the aspects of acceptance activities, 

handling, storage, distribution, and 

installation
Production and Process Controls:

Purpose

• Manufacture products that meet pre-determined specifications

– Develop, conduct, control and monitor production processes

– Validate or fully verify processes

– Ensure that a device conforms to its specifications

– Control the product and environment throughout handling, 

storage, distribution, and installation

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Regulatory Requirements

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Subpart Title Regulation Number 

(21 CFR)

Subpart H - Acceptance 

Activities

Receiving, in-process, and finished 

device acceptance

820.80

Acceptance Status 820.86

Subpart L – Handling, 

Storage, Distribution, and 

Installation

Handling 820.140

Storage 820.150

Distribution 820.160

Installation 820.170
Acceptance Activities

• Receiving, in-process, and finished device acceptance

– Establish and maintain procedures for acceptance activities 

including inspections, tests, or other verification activities

21 CFR 820.80(a)

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Acceptance Activities 

• Receiving acceptance activities 

– Establish and maintain procedures for acceptance of incoming product

• Inspect, test or otherwise verify that incoming product conforms to 

specified requirements

• Document acceptance or rejection

21 CFR 820.80(b)

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Acceptance Activities

• In-process acceptance activities

– Establish and maintain acceptance procedures, where appropriate, to ensure 

that in-process product:

• Meets specified requirements

• Is controlled:

o until required inspections, tests or other verification 

activities have been completed;

o until necessary approvals are received and documented

21 CFR 820. 80(c)

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Acceptance Activities

• Final acceptance activities 

– Establish and maintain procedures for finished device 

acceptance to ensure that each production run, lot or batch 

meets acceptance criteria

– Hold finished devices in quarantine or control them until 

released

21 CFR 820. 80(d)

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Acceptance Activities

• Final acceptance activities 

– Conduct the following activities before releasing finished devices for 

distribution:

• Complete all activities required in the Device Master Record (DMR) 

• Review associated data and documentation 

• Authorize release by signature and date of designated individual

21 CFR 820.80(d)

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Implementation

• Use of risk based approach for acceptance activities

o Frequency of testing may be different based on risk

o Low risk components may require less testing than a high risk 

component

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Implementation

• Types of systems used for implementation

– Kanban systems

– Electronic

o Bar-coded systems that can tell you status of each item – accepted, 

rejected, in process testing

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Acceptance Activities: Example

• Receiving inspection 

o Tubing strength testing

Balloon tubing versus packaging tubing

• In Process Inspection 

o Bond strength testing

• Final Acceptance testing

o Leak testing of catheter

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Acceptance Activities

• Acceptance records 

– Documentation of required acceptance activities include: 

• Acceptance activities performed 

• Dates performed

• Results obtained 

• Signature of individual(s) conducting activities 

• Equipment used (where appropriate)

– These records shall be part of the Device History Record (DHR)

21 CFR 820. 80(e)

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Preamble On Acceptance Records

......Where product fails to pass acceptance activities, the 

procedures for control of nonconforming product must be 

implemented to include investigations where defined. If the 

acceptance records are not clear about how the product failed, 

then the manufacturer may end up duplicating the acceptance 

activities in order to perform appropriate investigations.

Preamble Comment # 147, 2nd paragraph

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Acceptance Activities

• Acceptance Status 

– Identify acceptance status with acceptance criteria:

o conformance, or 

o nonconformance

– Maintain acceptance status identification:

o throughout manufacturing, packaging, labeling, installation, and servicing 

o to ensure only product which has passed required acceptance activities is 

distributed, used, or installed

21 CFR 820. 86

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Regulatory Requirements

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Subpart Title Regulation Number 

(21 CFR)

Subpart H - Acceptance 

Activities

Receiving, In-Process, and 

Finished device Acceptance

820.80

Acceptance Status 820.86

Subpart L – Handling, 

Storage, Distribution, and 

Installation

Handling 820.140

Storage 820.150

Distribution 820.160

Installation 820.170
Handling

• Handling

– Establish and maintain handling procedures to prevent:

o Mix-ups

o Damage

o Deterioration

o Contamination

o Other adverse effects to product

21 CFR 820.140

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Handling: Example

• Use of :

– Anti-static measures

– Gloves

– Holding fixtures

– Piping

– Conveyors

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Handling: Example

• To prevent mix ups -

o Use of bins/carts/trays to move product

• To prevent deterioration especially for electrostatic 

discharge (ESD) sensitive products

o Use of ESD protective containers/packages

o ESD hoods

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Reminder

• Use of “acceptance status” of parts is clearly notated 

when moving from: 

– station to station

– start to finish

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Storage

• Storage 

– Establish and maintain procedures for control of storage areas 

and stockrooms to prevent product:

o Mix-ups

o Damage

o Deterioration

o Contamination

o Other adverse effects

21 CFR 820.150 (a) 

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Storage

• Storage 

– Establish and maintain procedures to ensure that no 

product is used or distributed if:

o Obsolete,

o Rejected, or

o Deteriorated

– Store product to facilitate stock rotation if quality of 

product deteriorates over time

21 CFR 820.150(a)

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Storage

• Storage

– Establish and maintain procedures describing methods for 

authorizing receipt from and dispatch to storage areas and 

stock rooms

21 CFR 820.150(b)

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Implementation

• Storage area is contained

• Product is accounted for

• Acceptance status is notated

• Who can add or remove is designated and controlled

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Implementation

• Controls for storage areas that may be considered for 

implementation include:

– Security controls: limited access

– Environmental controls: temperature, humidity, UV light

– Contamination controls: dust free conditions

– Personnel controls: cleanliness conditions

– Packaging and handling controls: fragile products

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Storage: Example

• Use of:

– Cages

– Red tag/green tag designation

– Electronic system

– Segregation/clearly labeled process

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Distribution

• Distribution

– Establish and maintain procedures to ensure:

o Only devices approved for release are distributed

o Purchase orders are reviewed; ambiguities and errors are 

resolved before release for distribution 

o Expired or deteriorated devices are not distributed

21 CFR 820.160(a)

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Distribution

• Distribution

– Maintain distribution records which include or refer to the location of:

o Name and address of the initial consignee

o Identification and quantity of devices shipped

o Date shipped

o Any control number(s) used

21 CFR 820.160(b)

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A Common DICE Question

When is a device considered 

to be “in distribution”?

• All the forms are signed

• Leaves the building

• In a distribution warehouse 

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A Common DICE Question

When is a device considered 

to be “in distribution”?

• All the forms are signed

• Leaves the building

• In a distribution warehouse 

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Installation

• Installation

– Ensure proper installation, by establishing and maintaining 

adequate:

o Installation instructions; 

o Inspection instructions; and 

o Test procedures (where appropriate)

– Ensure instructions and procedures are available to 

person(s) installing device

21 CFR 820.170(a)

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Installation

• Installation

– The person installing the device shall:

o Ensure installation, inspection, and any required testing are 

performed in accordance with the instructions and procedures

o Document inspection and any test results

o Demonstrate proper installation

21 CFR 820.170(b)

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Installation: Example

• If installation is included as part of the design:

– installation instructions need to be provided

– training is performed by qualified individuals

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QS Regulation and Guidance

• Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-goodmanufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-finalrule-quality-system-regulation

• Compliance Program Guidance Manual: INSPECTION OF MEDICAL DEVICE 

MANUFACTURERS

www.fda.gov/media/80195/download

• Guide to Inspections of Quality Systems [Quality System Inspection 

Technique (QSIT)]

www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspectionguides/quality-systems

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Summary

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• The production and process controls subsystem 

ensures that manufactured products meet 

specifications

• This subsystem includes acceptance activities, 

handling, storage, distribution, and installation
Industry Education:

Three Resources for You

1. CDRH Learn: Multi-Media Industry Education

 over 125 modules

 videos, audio recordings, power point presentations, software-based “how to” modules

 mobile-friendly: access CDRH Learn on your portable devices

www.fda.gov/Training/CDRHLearn

2. Device Advice: Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics

www.fda.gov/MedicalDevices/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Contact DICE if you have a question

 Email: DICE@fda.hhs.gov

 Phone: 1(800) 638-2041 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)

 Web: www.fda.gov/DICE 37
Your Call to Action

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1. Make sure you document acceptance activities 

and the status of product

2. Ensure that product is controlled throughout 

handling, storage, distribution, and installation
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