Production and Process Controls

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
Production and Process Controls:

Why Are They Important?

Manufacture products that meet

pre-determined specifications

2
Learning Objectives

1. Explain how Production and Process Controls relate to the 

overall Quality System

2. Describe the general aspects of Production and Process 

Controls

3. Describe the aspects of inspection, measuring, and testing 

equipment

4. Define the concept of Process Validation

3
The 7 Subsystems of a Quality System 

Design 

Controls

Material

Controls

Records,

Documents, &

Change Controls

Equipment & 

Facility 

Controls

Production & 

Process 

Controls

Corrective &

Preventive

Actions

Management

4
Production and Process Controls:

Titles and Regulation Number

5

Subpart Title Regulation Number 

(21 CFR)

Production and Process 

Controls

Production and Process Controls 820.70

Inspection, Measuring and Test 

Equipment

820.72

Process Validation 820.75
6

Subpart Title Regulation Number 

(21 CFR)

Production and Process 

Controls

Production and Process Controls 820.70

Inspection, Measuring and Test 

Equipment

820.72

Process Validation 820.75
General Process Controls

21 CFR 820.70(a)

• Develop, conduct, control and monitor 

production processes

• To ensure that a device conforms to its 

specifications

7
General Process Controls:

Example

To ensure proper sealing

• Develop a package sealing process

• Account for temperature, pressure, and time

• Monitor the process over time

8
General Process Controls

21 CFR 820.70(a)(1) - (5)

• If deviations to specifications could occur as a 

result of manufacturing

9
General Process Controls

21 CFR 820.70(a)(1) - (5)

Include

1. Documented instruction, standard operating procedures (SOPs), and 

methods

2. Monitoring and control of process parameters

3. Compliance to reference standards

4. Approval of process and equipment

5. Criteria for workmanship

10
Product and Process Changes

21 CFR 820.70(b)

• Establish and maintain procedures for changes

– to specification, method, process or procedure

• Verify or validate (where appropriate) changes before 

implementation (per 21 CFR 820.75)

• Approve changes (per 21 CFR 820.40)

11
Environmental Control

21 CFR 820.70(c)

• If environment conditions could adversely effect 

product quality

• Establish and maintain procedures to adequately 

control them

12
Environmental Control

Examples

• Particles

• Humidity

• Air pressure, flow, filtration, ionization

• Temperature

• Lighting

• Sound

• Vibration

13
Environmental Control

Example

Rinsing Process

• Understand water source used for rinsing to prevent 

residue

14
Environmental Control

21 CFR 820.70(c)

• Periodically inspect environmental control 

system(s)

– to verify that system is adequate and functioning 

properly

• Document and review environmental control 

activities

15
Environmental Control

Examples

• Review humidity chart to ensure humidity levels 

are within operating window

• Check for electrostatic discharge station grounding

16
Personnel

21 CFR 820.70(d)

• Establish, maintain requirements for personnel:

– health

– cleanliness

– personnel practices

– clothing

• If contact between personnel and product may 

have adverse effect on product quality

17
Personnel

Examples

• Clothing restrictions or required uniforms

– for cleanrooms or electronic products

– examples: hair nets or smocks

• Personal hygiene

• Food and drink restricted areas

• Addressing illnesses at work

– respiratory, skin conditions

18
Preamble to Quality System 

Regulation: Importance

• Public Comments received to draft regulation

• FDA response to comments

• FDA clarification of intent of regulation

19
20

Preamble: Personnel

“... a manufacturer’s requirements must not permit unclean or inappropriately 

clothed employees, or employees with medical conditions, to work with 

devices where such conditions could reasonably be expected to have an 

adverse effect on product quality. The procedures must also address 

acceptable clothing, hygiene, and personal practices, if contact between 

personnel and product or environment could reasonably be expected to have 

an adverse effect on product quality.”

Preamble, Comment 129
Personnel

21 CFR 820.70(d)

• For maintenance and other personnel required to work 

temporarily under special environmental conditions

• Ensure appropriate training or supervision by trained 

individuals

21
Personnel: Example

• Janitorial staff or technicians who come to work on 

machines and need to enter a cleanroom

 They need to be trained, or supervised by a trained 

individual, when entering the cleanroom

22
Contamination Control

21 CFR 820.70(e)

• Establish, maintain procedures

• To prevent contamination of equipment/product

• By substances that could reasonably be expected to 

have an adverse effect on product quality

23
Contamination Control

Example

Cardboard Boxes

• If particulate from cardboard boxes may contaminate 

your product

• Do not store cardboard boxes in clean room

24
25

Preamble: Contamination Control

“Contamination control must include establishing and maintaining 

adequate cleaning procedures and schedules, if such control is necessary to 

meet manufacturing process specifications. In addition, Sec. 820.25 

Personnel, requires that employees have a thorough understanding of their 

job functions, which would include a requirement that the appropriate 

employees comprehend the cleanliness and sanitation procedures.”

Preamble, Comment 128
Buildings

21 CFR 820.70(f)

Buildings

• shall be of suitable design and contain sufficient space

– perform necessary operations

– prevent mix ups

– assure orderly handling

26
Equipment

21 CFR 820.70(g)

Ensure that all equipment used in manufacturing process:

• Meets specified requirements

• Is appropriately designed, constructed, placed, and 

installed

To facilitate maintenance, adjustment, cleaning and use

27
Equipment Maintenance Schedule

21 CFR 820.70(g)(1)

Establish, maintain schedules

• to adjust, clean and otherwise maintain equipment

• to ensure manufacturing specifications are met

Document maintenance activities

• include date and individual(s) performing maintenance activities

28
Equipment Inspection

21 CFR 820.70(g)(2)

Conduct periodic inspections per established procedures

• to ensure adherence to applicable equipment maintenance 

schedules

Document inspections

• including date and individual(s) conducting inspections

29
Equipment Adjustment

21 CFR 820.70(g)(3)

• Post any inherent limitations or allowable tolerances

– visibly or near equipment requiring periodic adjustments

• Or make information readily available to persons 

performing adjustments

30
Manufacturing Material:

Definition

Any material or substance used in or used to facilitate the 

manufacturing process, a concomitant constituent, or a byproduct 

constituent produced during the manufacturing process, which is 

present in or on the finished device as a residue or impurity not by 

design or intent of the manufacturer

21 CFR 820.3(p)

31
32

Preamble: Manufacturing Material

“FDA amended the definition of manufacturing material to help 

clarify this definition. Concomitant material refer to those 

material or substances that naturally occur as part of the material 

or during the manufacturing process which are intended to be 

removed or reduced in the finished device...”

Preamble, Comment 26
Manufacturing Material

21 CFR 820.70(h)

• Establish, maintain procedures for use and removal of 

manufacturing material where it could reasonably be 

expected to have an adverse effect on product quality

33
Manufacturing Material

Example

• Concomitant constituents 

– The allergenic or adverse proteins that occur 

naturally in the natural rubber latex components

34
Manufacturing Material

Example

• Use and removal may be part of another procedure

• Procedures should have an associated data form for 

recording values

• SOPs, data forms, and purchasing requirements are 

part of the Device Master Record

35
Automated Processes

21 CFR 820.70(i)

• Validate computer software used as part of production or 

Quality System for its intended use

• Validate according to established protocol

• Validate all software changes before approval and issuance

• Document validation activities and results

36
Automated Processes

Examples

• Injection molding process

• Statistical process control software

• Complaint tracking software

• Inventory tracking

• Document control

37
38

Subpart Title Regulation Number 

(21 CFR)

Production and Process 

Controls

Production and Process Controls 820.70

Inspection, Measuring and Test 

Equipment

820.72

Process Validation 820.75
Control of Inspection,

Measuring and Test Equipment

21 CFR 820.72(a)

• Ensure that all inspection, measuring, and test 

equipment is suitable for intended purposes and 

capable of producing valid results

39
Why Control Equipment?

• Used to evaluate whether product does or does not 

conform design, process validation and routinely in 

production

• Must provide valid results for evaluation to be 

meaningful

40
Control of Inspection,

Measuring and Test Equipment

21 CFR 820.72(a)

• Establish procedures to ensure equipment is routinely 

inspected, checked, maintained and calibrated

– Address equipment handling, preservation, storage

• Document activities

41
Calibration

21 CFR 820.72(b)

• Establish procedures

– including specific directions/limits for accuracy and precision

• For valid results, equipment should be:

– Accurate

• how close the measured value is to actual value

– Precise

• proximity of multiple measurements to each other (that is, how close 

they are to each other)

42
Calibration

21 CFR 820.72(b)

• Include provisions for remedial action to

– reestablish limits

– evaluate for adverse effect on device quality

• Consider all usage since last known good condition

• Include “as found condition to recognize the need for 

remedial action”

43
Calibration Standards

21 CFR 820.72(b)(1)

Calibration standards must be traceable to:

• National standards

• International standards

• Independent reproducible standards

44
Calibration Records

21 CFR 820.72(b)(2)

• Must include:

– equipment identification

– calibration dates

– individual performing each calibration

– next calibration date

• Readily available and posted on/near equipment

45
46

Subpart Title Regulation Number 

(21 CFR)

Production and Process 

Controls

Production and Process Controls 820.70

Inspection, Measuring and Test 

Equipment

820.72

Process Validation 820.75
Process Validation:

Definition

• Establishing by objective evidence that a process 

consistently produces a result or product meeting its 

predetermined specifications

21 CFR 820.3(z)(1)

47
Process Validation:

For More Information

CDRH Learn Module: Process Validation

fda.yorkcast.com/webcast/Play/090c4052bc2b4f90ba94245204e745061d 

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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/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulati

ons/ucm230127.htm

• Inspection Guide 

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

• Guide to Inspections of Quality Systems [Quality System 

Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm

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Summary

1. We showed how Production and Process Controls relate to 

the overall Quality System

2. We discussed the general aspects of Production and Process 

Controls

3. We described the aspects of inspection, measuring, and 

testing equipment

4. We introduced the concept of Process Validation

50
Your Call to Action

Establish your Production and Process Controls, 

so you manufacture products that meet your 

specifications

51
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 52
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