FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.12

Revision #: 02

Revised:

05/15/2019

Title: 

Preventive Action Page 1 of 5

For the most current and official copy, check QMiS.

Sections in This Document

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

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

3. Responsibility............................................................................................................................1

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

5. References ...............................................................................................................................2

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

7. Glossary/Definitions..................................................................................................................4

8. Records ....................................................................................................................................4

9. Supporting Documents .............................................................................................................4

10. Document History .....................................................................................................................5

11. Change History.........................................................................................................................5

12. Attachments..............................................................................................................................5

1. Purpose

The procedure establishes the process to track and investigate potential 

nonconformances and address both risks and opportunities to establish a 

basis for increasing the effectiveness of the management system, achieving 

improved results and preventing negative effects in the Office of Regulatory 

Science (ORS) laboratories quality management system. The cornerstone of 

preventive action is written and retrievable records of actions taken and followup monitoring to determine that preventive actions have been implemented 

and recorded.

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 encompassing the initiation of 

actions to prevent or minimize deviations or potential risks to the quality 

system.

3. Responsibility

A. Management
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.12

Revision #: 02

Revised:

05/15/2019

Title: 

Preventive Action Page 2 of 5

For the most current and official copy, check QMiS.

1. Evaluates risks and opportunities within the quality system for areas 

that would merit preventive actions.

2. Identify preventive actions to address risks and opportunities during 

Management Review.

3. Approve preventive actions for implementation.

4. Ensure that preventive actions are identified, action plans are 

developed, and follow-up is completed.

B. Employees

1. Identify preventive actions and use the Preventive Action form to 

record, initiate, and perform identified preventive action(s).

C. The Quality System Manager

1. Monitors preventive actions for effectiveness, and timely completion

2. Maintains all records generated during preventive actions in QMiS, 

including their investigation(s) and resolution(s).

4. Background

Improvements, potential sources of nonconformities, and potential negative 

effects on laboratory activities, either technical or concerning the management 

system, shall be identified and evaluated. Preventive action plans are part of a 

proactive process for improvement rather than a reaction to problems or 

complaints. Preventive action includes the use of sources of information such 

as processes and work operations which affect the quality system, audit 

results, and quality records to detect, analyze, reduce the likelihood for 

potential nonconformances and take advantage of opportunities for 

improvement.

5. References

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

testing and calibration laboratories, Section 8.5.

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. ORA-QMS.008 Preventive Action (ORA-Level)
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.12

Revision #: 02

Revised:

05/15/2019

Title: 

Preventive Action Page 3 of 5

For the most current and official copy, check QMiS.

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

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

6. Procedure

A. Preventive action plans are part of a proactive process for improvement 

rather than a reaction to problems or complaints. Risks and 

opportunities associated with the laboratory activities are considered to 

prevent or reduce undesired impacts and potential failures in the 

laboratory activities. 

B. Potential undesired impacts and failures and areas for improvement 

may be identified using any of the following:

1. Information sources such as processes and work operations that 

affect quality, audit results, quality records and feedback.

2. Measurable quality objectives and requirements, validation and 

review processes, audits and management review, feedback, and 

the quality system and ISO requirements.

3. Proficiency samples, internal quality control samples and QC charts 

that are monitored for trends or biases.

C. The preventive action process consists of:

1. Reviewing potential problems or risks

2. Determining the potential cause of the problems;

3. Developing a course of action

4. Putting the plan into action; and

5. Then ensuring or verifying the action solved the potential problem or 

is effective over time.

D. Actions taken to address risks shall be proportional to the potential 

impact on the validity of laboratory results. There are several possible 

options available such as:

1. Avoiding threats

2. Taking the risk to pursue an opportunity

3. Eliminating the risk source

4. Changing the likelihood or consequence 

5. Retaining the risk by informed decision
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.12

Revision #: 02

Revised:

05/15/2019

Title: 

Preventive Action Page 4 of 5

For the most current and official copy, check QMiS.

E. Preventive action plans are initiated once identified by starting a 

preventive action form in QMiS. 

F. The Quality System Manager is responsible for follow-up and ensuring 

the action plans are completed.

G. Monitoring the information and effectiveness of the preventive action is 

accomplished by any of the following:

1. control and process charts;

2. performance measurements and training;

3. customer inputs;

4. employee suggestions and inputs;

5. audits and management reviews; 

6. and management meetings

7. Glossary/Definitions

A. Non-conformance - This is a non-fulfillment of a specified, or implied, 

requirement of the Quality Management System or of a quality work 

product. Fitness-for-use criteria and evaluations determine the 

significance of a nonconformance.

B. Preventive action - This is an endeavor taken to eliminate the cause of 

a potential nonconformity or other potentially undesirable situation to 

prevent occurrence.

8. Records

A. Preventive Action form

B. Action plans

C. Management Review

9. Supporting Documents

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

Review
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.12

Revision #: 02

Revised:

05/15/2019

Title: 

Preventive Action Page 5 of 5

For the most current and official copy, check QMiS.

10. Document History

Revision

#

Status*

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

1.2 R 11/16/05 LMEB LMEB

1.3 R 12/06/06 LMEB LMEB

1.4 R 12/31/07 LMEB LMEB

1.5 R 02/06/12 LMEB LMEB

1.6 R 03/25/13 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

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

11. Change History

Revision 

# Change

02

Updated formatting. Replaced LD, Branch Director, Supervisor with “Managers” in 

Responsibilities. Added QMiS. Added Management Review to Records. Updated 

references. Changed flow of procedure & clarified wording. Added ORA CAPA 

procedure to Reference section. Other revisions as needed to align with recentlyrevised ISO and AOAC standards.

12. Attachments

None