FOOD AND DRUG ADMINISTRATION Document Number:

Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 1 of 8
Corrective Action

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.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 2 of 8
Corrective Action

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

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 3 of 8
Corrective Action

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.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 4 of 8
Corrective Action

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.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 5 of 8
Corrective Action

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.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 6 of 8
Corrective Action

1.1 Process Map

Identify
nonconformance

Record

Investigate/Evaluate

Yes or No

Correction Only

YES NO

Make Correction Root Cause Analysis

Cycle until nonconformance does not recur

Develop Corrective/
Preventive Action Plan
Record

Implement Plan

Evaluate during
internal audit and
management review.
Monitor Effectiveness

Close Out

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 7 of 8
Corrective Action

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

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.4.11
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 8 of 8
Corrective Action

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

For the most current and official copy, check QMiS.