FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised: 

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 1 of 7

For the most current and official copy, check QMiS.

Sections in This Document

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

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

Responsibility............................................................................................................................ 2

Background............................................................................................................................... 3

References ............................................................................................................................... 3

Procedure ................................................................................................................................. 3

6.1. Received by the laboratory ............................................................................................ 3

6.2. Evaluate Complaint / Feedback ..................................................................................... 3

6.3. Communicating with the Complainant............................................................................ 4

6.4. Escalation outside of laboratory..................................................................................... 4

6.5. Records.......................................................................................................................... 4

6.6. Process Map .................................................................................................................. 4

Glossary/Definitions.................................................................................................................. 6

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

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

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

Change History......................................................................................................................... 7

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

Purpose 

The purpose of this procedure is to describe receipt, evaluation, resolution, 

and maintenance of records of complaints and feedback regarding Office of 

Regulatory Science (ORS) laboratory activities. Complaints and feedback can 

provide valuable information on the effectiveness of the organization and can 

be used to improve the organization with the customer in mind.

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.

This procedure applies to complaints; positive and negative feedback; results 

of customer surveys; and internal or external suggestions for improvements 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised: 

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 2 of 7

For the most current and official copy, check QMiS.

that impact ORS laboratories’ work products, services, and processes. This 

procedure is not used for personnel issues.

Responsibility 

A. Laboratory Management

1. Implements this procedure at their unit level.

2. Collaborates with the Quality System Manager (QSM) to gather and 

verify all necessary information to validate complaints and to 

determine the appropriate response.

3. Ensures implementation of corrective and/or preventive actions as 

necessary.

B. Staff

1. Record complaints and feedback received on the Complaint 

Feedback (CF) form in QMiS.

2. Initiate Issue Review form for negative feedback or complaints 

received. 

C. Quality System Manager (QSM)

1. Evaluates and processes CF forms entered in QMiS. 

2. Works with management to assess the CF (e.g. gathering and 

evaluating necessary information to validate complaints, reviewing 

affected processes and procedures, facilitating root cause analysis) 

and determine appropriate action.

3. Initiates Issue Review form, if not already done, to record evaluation 

of complaints.

4. Ensures complaints and feedback are recorded, tracked, and 

trended in QMiS. 

5. Recommends and initiates corrective action and/or preventive 

actions to management as necessary.

6. Monitors the CFs in QMiS to ensure resolution is satisfactory and 

complete.

7. Reports on complaints and feedback highlights and trends at 

management meetings and during management review.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised: 

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 3 of 7

For the most current and official copy, check QMiS.

Background 

None

References 

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

testing and calibration laboratories, Sections 7.9 and 8.6.

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-000116 Complaints and other Feedback (ORA-Level)

Procedure 

6.1. Received by the laboratory

Complaints and feedback may be received by various means, such as in 

writing, e-mail, telephone, web application, information management systems, 

or in person. 

Staff at the laboratory who receive a complaint or feedback shall record it by 

initiating a Complaint_Feedback (CF) form in QMiS. This form is used to 

record both positive and negative feedback.

6.2. Evaluate Complaint / Feedback

The QSM consults with management and subject matter experts to evaluate 

complaints and feedback and determine if they relate to laboratory activities. 

Results of evaluation and actions taken are recorded on the CF form. The 

QSM may add others to the CF form to record this information, as needed.

A. If a nonconformance is discovered because of a complaint the 

corrective action process shall be initiated with generation of an Issue 

Review form in QMiS which provides escalation to a Corrective 

Action/Preventive Action (CAPA). 

B. The CF is closed once the CAPA is closed out.

C. If an opportunity for improvement is identified the improvement form 

may be initiated. 

D. A qualified person must review complaints for possible failures and 

investigate where needed (AOAC 2018). A qualified person is an 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised:

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 4 of 7

For the most current and official copy, check QMiS.

employee with technical knowledge of the product or activity area (for 

example dietary supplements and pharmaceuticals) of the complaint. 

6.3. Communicating with the Complainant

A. Whenever possible, the QSM or responsible Manager acknowledges 

receipt of a complaint and provides the individual filing the complaint 

with progress reports.

B. Outcomes to be communicated to the complainant are reviewed and 

approved (by individuals not involved in the original laboratory activities 

in question) through the corrective action approval process or within the 

complaint process.

C. The QSM or responsible Manager communicates actions taken and 

outcomes to the complainant as formal notice of the end of the 

complaint handling process, where possible.

6.4. Escalation outside of laboratory

Complaints or other feedback (CF) may be escalated if the issue cannot be 

resolved locally or if the issue impacts multiple units. Refer to SOP-000116 

Complaints and Other Feedback.

6.5. Records

Complaint and feedback records are maintained in QMiS. The complaints and 

feedback are reviewed as part of the internal audit and management review to 

identify any trends and to ensure any changes from a complaint or feedback 

were proper, effective, timely and successful.

6.6. Process Map
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised: 

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 5 of 7

For the most current and official copy, check QMiS.

Feedback Recieved

Record Feedback

Nonconformance?

Initiate Nonconforming 

Work/Corrective Action 

Process via Issue Review 

form

Take action to satisfy 

customer complaint

Record action taken

Evaluate during internal audit and 

management review.

Elevate outside laboratory?

Evaluate

Follow 

SOP-000116

YES NO NO YES

Notify complainant of outcomes and 

completion of process, where possible
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised: 

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 6 of 7

For the most current and official copy, check QMiS.

Glossary/Definitions

A. Complaints – Complaints are negative reactions usually in written form 

made to the organization related to a specific product or service 

produced or provided by the organization after the product has been 

released or service completed.

B. Corrective action – This is the action taken to eliminate the causes of a 

detected non-conformance, defect, or other undesirable situation to 

prevent reoccurrence.

C. Feedback – Can be positive or negative. It is important to include 

reviews of positive feedback as this can provide evidence of what is 

working well in the quality system. 

Records

A. Complaint Feedback form

B. Issue Review/CAPA form

C. Improvement Action form

Supporting Documents

A. MAN-000029 ORA Laboratory Manual, Volume II, ORA-LAB.4.9, 

Control of Nonconforming Work

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

Corrective Action Procedure

Document History

Revision

# I Date Author Name and Title Approving Official Name and Title

02 I See QMiS LMEB LMEB

03 R See QMiS LMEB LMEB

* - D: Draft, I: Initial, R: Revision
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000028

Revision #: 03

Revised: 

31 Oct 2023

Title: 

ORA Lab Manual Vol. II - Complaints and Feedback (ORA-LAB.4.8) Page 7 of 7

For the most current and official copy, check QMiS.

Change History

Revision 

# Change

02

Updated formatting. Added “feedback” to title/scope. Added evaluation guidance for 

nonconformance vs. feedback. Added section for escalation; updated process flow 

chart. Other revisions to align with recently revised ISO and AOAC standards.

03

Updated with missing step to initiate Issue Review form to evaluate complaints and escalate 

to CAPA, if needed. Removed references to Preventive Action form (no longer in use) and 

replaced with Improvement form. Added “Feedback” to Glossary. Added QMiS ID numbers to 

supporting documents cited.

Attachments

NONE