Science & Research

Volume II - Complaints ORA-LAB.4.8

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ORA Laboratory Procedure
Food and Drug Administration

Complaints ORA-LAB.4.8

Sections included in this Document and Change History

  1. Purpose
  2. Scope
  3. Responsibility
  4. Background
  5. References
  6. Procedure/(6.B. --Division of Field Science and DFS changed to Office of Regulatory Science and ORS)
  7. Definitions
  8. Records(revised form names)
  9. Supporting Documents
  10. Attachments
  11. Document History

1. Purpose

To describe the procedure for the receipt, resolution, and maintenance of records of complaints regarding FDA, Office of Regulatory Affairs (ORA) laboratory activities. Complaints are objections, errors, or non-conformities involving work quality, or failures to provide service or other requests of the customer including timeliness. Complaints can provide valuable feedback on the effectiveness of the organization and can be used to improve the organization with the customer in mind.

2. Scope

This procedure is applicable to all FDA, ORA laboratory organizational units and personnel.

3. Responsibilities

Laboratory management is responsible for ensuring the implementation of the complaint procedure and facilitates process changes. Supervisors and staff are responsible for recording complaints received on the complaint form, initiating corrective action or submitting to the local manager for corrective action. The Quality System Manager (QSM) Manager monitors the comments and complaints received for trends, resolutions and corrective action.

4. Background


5. References


6. Procedure

  1. Complaints may be lodged by various means in writing, electronically through e-mail, by telephone, web application, and in person.
  2. Complaints can result from:
    • internal customers which include other laboratory branches and offices within the laboratory’s regional/district office;
    • external customers which includeOffice of RegulatoryScience (ORS), other ORA districts, FDA Centers, other government agencies, regulated industry, private laboratories, or consumers; and
    • staff.
  3. Complaints may be categorized by their source and impact on work quality or service to customers. Complaint categories are as follows:
    • Level I – complaints received internally;
    • Level II – complaints received from other ORA laboratories, districts, Division of Field Science or Centers; and
    • Level III – complaints received from outside FDA.

6.1 Receiving Complaints

  1. Staff who receive a complaint documents it on the Complaint Feedback form (CF).
  2. The CF form includes:
    1. the affiliation of the person and organization who lodged the complaint,
    2. the date the complaint was received, and
    3. the nature of the complaint.

6.2 Processing Complaints

  1. If the person receiving the complaint can determine the cause and the corrective action, they should take the corrective measures, complete the complaint form and forward it to the identified supervisor.
  2. If the cause and corrective action can not be determined by the person receiving the complaint, submission of the complaint is made to laboratory management.
  3. Any complaint that cannot be resolved is referred to the next higher level of management.
  4. A corrective action report is generated and the laboratory’s corrective action process initiated. This process involves the determination and investigation of adverse impact on operations and quality.

6.3 Closing and Monitoring

  1. When the corrective action has been completed, the complaint is closed. The CF and corrective action form is submitted to the identified manager.
  2. Both forms are submitted to the Quality System Manager who reviews the CF for completeness and files the forms (non-electronic system) or signs off on the form (electronic system).
  3. Complaints are reviewed in the internal audit and management review to ensure any changes from a complaint were proper, effective, timely and successful.

6.4 Complaint Process Flowchart

  1. The complaint process is illustrated in the flowchart.

    Flow Chart - Complaint process

7. Definitions

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.

Corrective action – This is the action taken to eliminate the causes of a detected non-conformance, defect or other undesirable situation in order to prevent reoccurrence.

8. Records

Complaint Feedback form
Nonconformance Corrective Action form

9. Supporting Documents

ORA Laboratory Manual,Volume II, Section 1, ORA-LAB.4.11 Corrective Action Procedure.

ORA-QMS.009, Complaints and Other Feedback

ORA-QMS.007, Corrective Action Procedure

10. Attachments


11. Document History

Version No. Status (I, R, C) Date Approved Location of Change History Name & Title
Author Approving Official
1.3 R
In Document LMEB LMEB
1.4 R 02-06-12 In Document LMEB LMEB
1.5 R 01-22-13 In Document LMEB LMEB

Approving Official’s signature: _________________________________ Date: _____________

Page Last Updated: 03/18/2016
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