Nonconforming Product

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
Nonconformances:

Why Are They Important?

Opportunity for Continuous improvement

• Learn from Mistakes

• Product longevity

• Increased market share

• Better, safer, more effective product

2 
Learning Objectives

1. Understand context of nonconformances within:

• Overall Quality System and

• Corrective and Preventive Action (CAPA) subsystem

2. Define nonconforming product

3. Explain the process flow

4. Learn how nonconforming product disposition contributes to quality and 

safety

3 
What is the CAPA Subsystem?

• One of the seven Quality System subsystems

• Corrective and Preventive Action (CAPA) Subsystem

4 

Parts of CAPA Subsystem Regulation Number

(21 CFR)

General Applicability

Nonconforming Product 820.90 Manufacturing

Corrective and Preventive 

Action

829.100 Manufacturing and 

After Distribution

Complaint Files 820.198 After Distribution
Definitions (21 CFR 820.3)

• Specification 

any requirement with which a product, process, service, or 

other activity must conform [21 CFR 820.3(y)] 

• Product

components, manufacturing materials, in-process devices, 

finished devices, and returned devices [21 CFR 820.3(r)]

• Nonconformity 

the nonfulfillment of a specified requirement [21 CFR 820.3(q)]

5 
Nonconformances

• Nonconforming Product is product that does not fulfill its 

specified requirements 

• Nonconformances can occur in both product and process

• Nonconforming processes can lead to nonconforming 

product. 

6 
Nonconforming Product - Regulation

21 CFR 820.90(a)

“Each manufacturer shall establish and maintain 

procedures to control product that does not 

conform to specified requirements....”

7 
Nonconforming Product - Regulation

21 CFR 820.90(a)

“....The procedures shall address the 

identification, documentation, evaluation, 

segregation, and disposition of nonconforming 

product.”

8 
Process Flow 

Identification

9 
Process Flow 

Documentation

Identification

10
Process Flow 

Documentation

Identification

Evaluation

11
Process Flow 

Documentation

Identification

Evaluation

Segregation

12
Process Flow 

Documentation

Identification

Evaluation

Segregation

Disposition

13
Process Flow

Identification

14
Sources of Nonconforming Product 

• Received components/material that fail incoming 

inspection

• Example

– Specification: 6 +/- 1 inch

– Inspection result: 8 inch

– This is nonconforming product

15
Sources of Nonconforming Product 

• Products/components that fail inspection or test during 

manufacturing

• Example

– Temperature range: 300 ± 10° F 

– Temperature set on bonding machine: 280° F 

– This is nonconforming process: 

• You need to evaluate the product to determine if it’s within specification.

16
Sources of Nonconforming Product 

• Product returned to manufacturer with defects

• Example

– If a catheter is supposed to fit inside a 6 French guide and 

during procedure it does not fit. 

– Handled within the complaint system*

 *not within the scope of this talk

17
Industry Practice: Example

• Nonconformances and Nonconforming reports (NCR) 

have to be evaluated. 

• One practice is through 

– Material Review Board (MRB) or

– Material Review Committee (MRC)

• Not ad hoc, but in an approved procedure 

18
Process Flow

Documentation

19
Documentation - Industry Practice 

Example

• Form that identifies the material, the problem, 

evaluation, segregation, the investigation (if 

any), disposition and signatures

• Standard operating procedure (SOP)

• Work Instruction (WI)

20
Process Flow

Evaluation

21
Evaluation of Nonconforming Product

21 CFR 820.90(a)

... The evaluation of nonconformance shall include a 

determination of the need for an investigation and 

notification of the persons or organizations responsible

for the nonconformance. The evaluation and any 

investigation shall be documented.

22
Evaluation of Nonconforming Product

21 CFR 820.90(a)

Investigations are Not Always required

– when an investigation has already been performed on 

a similar issue*

*Similar issue may not require investigation, but may 

require CAPA due to recurrence. 

23
Process Flow

Segregation

24
Segregation of Nonconforming Product

• You must segregate non-conforming product to 

ensure it is not released.

• Examples

– Locked Cages

– Digital Controls

– Separate Area

25
Process Flow

Disposition

26
Disposition

21 CFR 820.90(b)(1) 

Each manufacturer shall establish and maintain 

procedures that define the responsibility for review and 

the authority for the disposition of nonconforming 

product. The procedures shall set forth the review and 

disposition process. 

27
Typical Nonconforming Product 

Dispositions

• Scrap 

– where you decide not to use the 

product

– destroy 

28
Typical Nonconforming Product 

Dispositions

• Return to Supplier 

– When the reason for the nonconformance is 

the supplier

29
Typical Nonconforming Product 

Dispositions

• Downgrade

– Reverting back to a safe and effective older 

version when there is a problem with an 

upgrade

30
Typical Nonconforming Product 

Dispositions

• Use as Is

– Use the Nonconformance as is when it does not 

affect the safety and effectiveness of the final 

product 

– Example: Cosmetic defects that does not affect the 

performance of the product

31
Disposition

21 CFR 820.90(b)(1)

Disposition of nonconforming product shall be 

documented. Documentation shall include the 

justification for use of nonconforming product and the 

signature of the individual authorizing the use.

32
Typical Nonconforming Product 

Dispositions

“... FDA believes that the justification should be based on 

scientific evidence, which a manufacturer should be 

prepared to provide upon request. Concessions should be 

closely monitored and not become accepted practice” 

Per preamble comment #156

33
Typical Nonconforming Product 

Dispositions

• Use as Is

– Example

• Cosmetic defect: refer recurring defect to 

CAPA.

34
Typical Nonconforming Product 

Dispositions

• Rework

– Example

• Product with unsealed pouches at final acceptance 

testing 

• Open NCR

• Correction is Re-sterilize

• Retest

35
Rework

21 CFR 820.90(b)(2) 

Each manufacturer shall establish and maintain 

procedures for rework, to include retesting and 

reevaluation of the nonconforming product after rework, 

to ensure that the product meets its current approved 

specifications. 

36
Typical Nonconforming Product 

Dispositions

• Rework

– Example

– Balloon burst strength of re-sterilized product 

needs to meet the original specification

37
Rework

21 CFR 820.90(b)(2)

Rework and reevaluation activities, including a 

determination of any adverse effect from the rework 

upon the product, shall be documented in the DHR

[Device History Record].

38
When should a Nonconformance be:

1. handled under 21 CFR 820.90? or

2. referred to the CAPA System under 21 CFR 820.100?

39

When to Handle and When to Refer
Examples of Nonconformances Handled 

under 820.90

• Easy/specific correction

• Isolated

• Minor

• Not a Design issue

• Not a Manufacturing issue

40
Examples of Nonconformances Handled 

under CAPA

• No easy/specific correction

• Recurring (based on valid analytical method)

• Severe

• Design issue

• Manufacturing issue 41
Balance is Key

• Too many nonconformances handled under 21 CFR 

820.90 may fail to address systemic issues.

o Generally simple, specific, contained issues

• Too many nonconformances referred to CAPA will 

overwhelm the system.

o Generally more complex, ambiguous, systemic issues

42
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 – Nonconforming Product

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114934.htm

• Guide to Inspections of Quality Systems [Quality System 

Inspection Technique (QSIT)]

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

43
Call to Action

1. Use your nonconformance system to “Learn from mistakes”. They 

can impact:

o Quality

o Design

o Manufacturing

2. Nonconformances are a gateway mechanism for CAPA and 

Postmarket activities

3. A robust nonconformance system can improve Quality and Safety

44
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 45
46