FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 1 of 7

For the most current and official copy, check QMiS. 

Sections in This Document 

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

Scope ....................................................................................................................................... 1

Responsibility............................................................................................................................ 1

Background............................................................................................................................... 2

References ............................................................................................................................... 2

Procedure ................................................................................................................................. 2

Figure 1. Process Map ..................................................................................................................... 5

Glossary/Definitions .................................................................................................................. 5

Records .................................................................................................................................... 6

Supporting Documents ............................................................................................................. 6

Document History ..................................................................................................................... 6

Change History ......................................................................................................................... 6

Attachments .............................................................................................................................. 7

Purpose 

Management performs, as a minimum, annual reviews to determine the fitness 

and effectiveness of the quality system in achieving the stated quality 

objectives. This procedure establishes the method by which management 

reviews are performed within the ORS Laboratories.

Scope 

This procedure applies to the management review (MR) process conducted on 

a routine basis by ORS laboratory management. 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. 

Responsibility 

A. Laboratory Director: 

1. Conducts management review. 

2. Assigns action items, plans, and approves system changes. 

3. Designates personnel to assist in the management review activities. 

B. Laboratory Management: 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 2 of 7

For the most current and official copy, check QMiS. 

1. Provides information and reports for review. 

2. Assists in the management review activities as designated. 

3. Ensures action items and plans issued are completed and identified 

system changes are implemented in their respective areas. 

C. Quality System Manager (QSM): 

1. Coordinates and collects the information for the management 

review. 

2. Documents action items and plans. 

3. Monitors implementation of system changes. 

4. Assembles and maintains management review records. 

Background 

Management reviews ensure the quality management system’s continuing 

suitability, adequacy, and effectiveness. The reviews are led by the senior 

manager and include evaluating the performance of the management system 

and assessing opportunities for improvement and the need for changes, 

including the quality policy and objectives. Actions and plans are established 

to implement improvements to the management system and its related 

processes. 

References 

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

testing and calibration laboratories, Section 8.9. 

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. 

Procedure 

A. A periodic review of the quality management system (QMS) is 

performed according to ORA procedures. This review examines the 

QMS and determines if it meets the conditions set by the agency and 

the standards. The review will serve as a guide in making future 

determinations towards the effectiveness and direction of the quality 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 3 of 7

For the most current and official copy, check QMiS. 

system. The quality system may need to be modified due to changes 

that have or are expected to take place in the organization, facilities, 

staffing, equipment, activities, or workload. 

B. The Quality System Manager gathers the information needed for the 

management review and provides it to the Laboratory Director and other 

management review participants. 

C. The management review addresses the inputs of the management 

system and includes but is not limited to the following elements: 

1. Changes in internal and external issues that are relevant to the 

laboratory. 

2. Fulfilment of objectives. 

3. Suitability of policies and procedures. 

4. Status of actions from previous management reviews. 

5. Outcome of recent internal audits. 

6. Corrective actions. 

7. Assessments by external bodies. 

8. Changes in the volume and type of the work or in the range of 

laboratory activities. 

9. Adequacy of resources. (Are there enough materials and/or 

resources (people) to meet the needs for processes in place or for 

changes in processes or activities?) 

10. Customer and personnel feedback. 

11. Complaints and effectiveness of their resolution. 

11. Effectiveness of any implemented improvements. 

12. Outcomes of risk identification. 

13. Outcomes of the assurance of the validity of results. 

Note: This review shall include a review of proficiency test results. 

14. Other relevant factors, such as monitoring activities and training 

program adequacy. 

15. Responses to agency mandates/requirements which may be 

communicated via a memo or email to management by the ACRA. 

D. Management reports the findings of the management review and 

actions according to ORA procedures. The outputs from the 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 4 of 7

For the most current and official copy, check QMiS. 

management review shall record all decisions and actions related to at 

least: 

1. The effectiveness of the management system and its processes. 

(i.e., How effective were you in meeting your objectives and goals? 

What actions can be taken to be effective in addressing risk and 

opportunities for improvement? Are there systemic issues or 

common themes that run through various instances?) 

2. Recommendations for improvement of the laboratory activities 

related to the quality system. 

3. Provision of required resources. 

4. Revised or new SMART objectives and targets for the upcoming 

year. 

NOTE: A SMART objective is one that is specific, measurable, 

achievable, relevant, and time-bound providing the details for how 

the laboratory will achieve a goal. They should be aligned with the 

ORA/ORS Strategic Plan where possible. 

E. Improvements, if any, are identified, implemented, and monitored. 

F. If needed, a corrective action is initiated for identified nonconformances 

in accordance with MAN-000033 ORA-LAB.4.11 Corrective Action 

Procedure. 

G. Management ensures actions are carried out within established 

timeframes. 

H. Action items and plans are closed when the results of the investigation 

are implemented or are judged as having no added value to the quality 

system. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 5 of 7

For the most current and official copy, check QMiS. 

Figure 1. Process Map 

Corrective 

Actions Audit Results

Effectiveness of 

the Mgt. system

Management Review Meeting

Inputs

Complaints & 

Feedback

Outcomes

Assessment by 

external bodies

Reports from 

management

Effectiveness of 

previous 

improvements

Proficiency Test 

Results

Determination of 

Suitability of policies 

and procedures

Preventive 

Actions

Other

(see ISO 17025 & 

AOAC requirements)

New Action Items 

with timeframes

Changes in volume 

and type of work

Report

Revised/New 

Objectives

Recommendations 

for improvement

Provision of 

resources

Adequacy of 

resources

Glossary/Definitions 

A. ACRA – Associate Commissioner for Regulatory Affairs 

B. Effectiveness – Effectiveness results when system requirements are 

routinely met. 

C. Management review – Management review is the evaluation of the 

quality system by management to determine its effectiveness, 

suitability, and future direction. 

D. Requirement – A requirement is a declared, implied, or routine need or 

expectation. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 6 of 7

For the most current and official copy, check QMiS. 

E. Suitability – Suitability is the property of a system with attributes that 

address the requirements of the Quality Management System. 

Records 

A. Management Review Report 

C. Action items and plans

Supporting Documents 

A. MAN-000028 ORA Laboratory Manual, Volume II, ORA-LAB.4.8 

Complaints and Feedback

B. MAN-000030 ORA Laboratory Manual, Volume II, ORA-LAB.4.11 

Corrective Action

C. SOP-000418 Management Review 

Document History 

Revision 

# 

Status* 

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

1.2 R 12/31/07 LMEB LMEB 

1.3 R 02/06/12 LMEB LMEB 

02 R 05/15/2019 LMEB LMEB 

03 R Refer to 

QMiS LMEB LMEB 

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

Change History 

Revision 

# Change 

02 Revisions made to align this procedure with new ISO/IEC 17025 and AOAC 

requirements. Revision to formatting and policy clarifications were made.

03 Added SMART requirement to align with ORA requirement. Added input/output suggestions to 

consider. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number: 

MAN-000034 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Management Review (ORA-LAB.4.15) Page 7 of 7

For the most current and official copy, check QMiS. 

Attachments 

None