FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 1 of 8

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................1

3. Responsibility............................................................................................................................2

4. Background...............................................................................................................................2

5. References ...............................................................................................................................3

6. Procedure .................................................................................................................................3

6.1. Review of Nonconformity ...............................................................................................3

6.2. Correction.......................................................................................................................3

6.3. Root Cause & Corrective Action ....................................................................................4

6.4. Monitoring for Effectiveness...........................................................................................4

6.5. Recording Correction(s) and Corrective Action(s) .........................................................5

1.1 Process Map ..................................................................................................................6

7. Glossary/Definitions..................................................................................................................7

8. Records ....................................................................................................................................7

9. Supporting Documents .............................................................................................................7

10. Document History .....................................................................................................................8

11. Change History.........................................................................................................................8

12. Attachments..............................................................................................................................8

1. Purpose 

To provide guidance in the process of identifying, evaluating, recording, 

investigating, correcting the causes of, and determining the disposition of 

nonconforming processes, services, and work products (hereafter referred to 

as nonconformances). The cornerstone of corrective actions is written and 

retrievable records of actions taken and follow-up monitoring to determine that 

corrective actions have been performed, documented, and found to be 

effective.

2. Scope

This procedure applies to the Office of Regulatory Science (ORS) laboratories 

and laboratory work products and processes. This procedure directly concerns 

the laboratory’s quality assurance program.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 2 of 8

For the most current and official copy, check QMiS.

3. Responsibility 

A. Managers:

1. Take action to control and correct nonconformances when they 

occur.

2. Ensure that corrective actions are performed, implemented, and 

communicated.

3. Review corrective actions that have been taken and approve or

recommend if further corrective actions are needed.

4. Complete appropriate sections of nonconformance and corrective 

action records in the Quality Management information System 

(QMiS).

B. Employees: 

1. Initiate and/or participate in the completion of corrective actions. 

2. Complete appropriate sections of the nonconformance and 

corrective action records in QMiS.

C. The Quality System Manager (QSM): 

1. Monitors the quality system for systematic problems. 

2. Facilitates the corrective action process.

3. Initiates corrective actions in QMiS when needed, i.e. as a result of 

complaints/feedback, nonconformances, audit results, management 

review, or other findings.

4. Monitors corrections and corrective actions for trends, effectiveness, 

and timely completion.

5. Maintains all records generated during corrections, corrective 

actions and their investigation(s), including objective evidence of 

actions taken, in QMiS.

4. Background 

Nonconformances can occur at various places within the quality system and 

technical operations. Examples include customer complaints, unacceptable 

quality control samples, instrument and sample problems, environmental 

problems that affect results, purchased materials for laboratory use, staff 

observations, management reviews and audits. Processes, services, and/or 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 3 of 8

For the most current and official copy, check QMiS.

products considered to be nonconforming may be identified in the following 

ways:

• Incoming product from suppliers

• Services provided by external sources (i.e. service contractors)

• Processes producing unacceptable results or products.

• Internal or External Quality Audits.

5. References 

A. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories, Section 8.7.

B. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018.

C. SOP-000235 Quality Event Management (QEM) and Corrective 

Action/Preventive Action (CAPA) (ORA-Level)

6. Procedure 

6.1. Review of Nonconformity

A. When a nonconformity occurs, the laboratory must take action to control 

and correct it with actions appropriate to the effects of the 

nonconformities encountered.

B. A review of the consequences of the nonconformity is performed to 

determine if a Correction or Corrective Action is warranted. 

6.2. Correction

A. If a minor nonconformance is detected where a product was not 

affected but absolute compliance to a statement of intent or clause of a 

standard was not met on basis of objective evidence, it can be recorded 

as a correction only with rectification actions recorded and closed. 

B. An obvious trend in a repeated minor nonconformance can escalate it to 

a corrective action.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 4 of 8

For the most current and official copy, check QMiS.

6.3. Root Cause & Corrective Action

A. Once a nonconformance that impacts a lab’s product, processes, or 

service is detected an evaluation of the need for action to eliminate the 

cause(s) will be performed. 

B. The laboratory determines if similar nonconformities exist or could 

potentially occur. 

C. An investigation to determine the root cause(s) of the problem will be 

initiated in order to determine an effective corrective action. 

D. Often the root cause is not obvious, therefore careful analysis of all 

potential causes of the problem is required. Areas to investigate can 

include:

1. Customer requirements

2. The samples or sample specifications

3. Methods and/or procedures

4. Staff skills and training

5. Consumables and/or vendors used

6. Equipment and its calibration

E. Once the root cause has been determined potential corrective actions 

shall be identified. 

1. Decide what can be done to prevent the problem from recurring.

2. Determine how the solution will be implemented.

3. Define who will be responsible for implementation.

4. Evaluate the risks of implementing the solution.

F. The corrective action(s) most likely to eliminate the problem and to 

prevent a recurrence shall be selected for implementation.

G. Changes required as a result of the investigation shall be recorded and 

implemented (i.e. procedure revisions, training, resumption of work 

where it was stopped due to the nonconformance, etc.).

H. The QSM closes the corrective action when there is objective evidence 

that the actions are completed and effective.

6.4. Monitoring for Effectiveness

A. Corrective actions that are implemented must be monitored to 

determine if they are and/or continue to be effective.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 5 of 8

For the most current and official copy, check QMiS.

B. The QSM can keep a completed action report open for a specified time 

to monitor effectiveness, and then close the issue once it has been 

determined to be effective.

C. Once an action report has been closed its effectiveness can still be 

determined with an audit in the area affected by the original 

nonconformance. 

D. In the event a corrective action is found to be ineffective a new 

nonconformance report will be initiated with a different root cause 

investigation to determine why the first corrective action was not 

effective, if the true root cause was determined, and to evaluate and 

identify the best corrective action to implement and record.

E. This additional corrective action must also under go monitoring to 

determine its effectiveness

6.5. Recording Correction(s) and Corrective Action(s)

Record nonconformance, investigation, correction, corrective action 

information in QMiS and according to local laboratory procedures. Instructions 

for using QMiS can be found within QMiS and local laboratory procedures.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 6 of 8

For the most current and official copy, check QMiS.

1.1 Process Map

Identify 

nonconformance

Record

Implement Plan

Root Cause Analysis

Record

Evaluate during 

internal audit and 

management review.

Correction Only

Investigate/Evaluate

Yes or No

Make Correction

YES NO

Develop Corrective/

Preventive Action Plan

Monitor Effectiveness

Close Out

Cycle until nonconformance does not recur
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 7 of 8

For the most current and official copy, check QMiS.

7. Glossary/Definitions 

A. Correction - action taken to render the work product acceptable for use 

by eliminating the detected nonconformity.

B. Corrective Action - The steps taken to eliminate the root cause(s) 

identified by a root cause analysis.

C. Deficiency – an alternate term used to describe a non-conformance.

D. Nonconformance – A non-fulfillment of a specified or implied 

requirement of the quality management system or of a quality work 

product.

E. Observation – a perceived or detected abnormality or anomaly that is 

not out of conformance to a specified or implied requirement; yet could 

possibly become a non-conformance if not acted upon or can be 

improved upon.

F. Preventive Action: Steps to mitigate or remove the underlying cause of 

a nonconformance.

G. QMiS – ORA’s Quality Management information System software. This 

is where corrective actions are recorded. (Refer to 9. Supporting 

documents for guidance on initiating, processing, and completing a 

nonconformance form in QMiS).

H. Root Cause(s) – The underlying reason (i.e. cause) that results in a 

nonconformance.

I. Root Cause Analysis – A systematic method of problem solving that 

identifies the root cause(s) of non-conformances.

8. Records 

A. Correction and Corrective Action Reports

B. Notes created during Root Cause investigation(s)

9. Supporting Documents 

A. QMiS User Manual

B. ORA Laboratory Manual, Volume II, ORA-LAB.4.9 Control of 

Nonconforming Work

C. ORA Laboratory Manual, Volume II, ORA-LAB.4.12 Preventive Action
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.11

Revision #: 02

Revised:

05/15/2019

Title: 

Corrective Action Page 8 of 8

For the most current and official copy, check QMiS.

D. ORA Laboratory Manual, Volume II, ORA-LAB.4.14 Audits

E. ORA Laboratory Manual, Volume II, ORA-LAB.4.15 Management 

Review

10. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.4 R 12/31/07 LMEB LMEB

1.5 R 02/06/12 LMEB LMEB

1.6 R 09/29/14 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision 

# Change

1.4 In Document

1.5 In Document

1.6 In Document

2.0 Complete revision to streamline process to align with actual process(es) in ORS.; 

removed 1st – 3rd level managers & replaced with authorities to be determined at the 

laboratory level for initiation/implementation. Changed “document” to record where 

appropriate. Added use of QMiS form. Updated flow chart. Added ORA CAPA procedure 

to Reference section. Other revisions as needed to align with recently-revised ISO and 

AOAC standards.

12. Attachments 

None