ORA Laboratory Manual Volume II Number: ORA-LAB.4.8 Revision #: 02 Revised: 05/15/2019 Title: Complaints and Feedback Page 3 of 6 For the most current and official copy, check QMiS. 5 ...
Title: FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II Document Number: ORA-LAB.4.8 Complaints and Feedback Revision #: 02 Revised: 05/15/2019 Page 1 of 6 Sections in This Document 1. Purpose ....................................................................................................................................1 2. Scope .......................................................................................................................................1 3. Responsibility............................................................................................................................2 4. Background...............................................................................................................................2 5. References ...............................................................................................................................3 6. 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 7. Glossary/Definitions..................................................................................................................5 8. Records ....................................................................................................................................6 9. Supporting Documents .............................................................................................................6 10. Document History .....................................................................................................................6 11. Change History .........................................................................................................................6 12. Attachments..............................................................................................................................6 1. 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. 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. This procedure applies to complaints; positive and negative feedback; results of customer surveys; and internal or external suggestions for improvements For the most current and official copy, check QMiS. Title: FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II Document Number: ORA-LAB.4.8 Complaints and Feedback Revision #: 02 Revised: 05/15/2019 Page 2 of 6 that impact ORS laboratories' work products, services, and processes. This procedure is not used for personnel issues. 3. 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 correction, corrective action, or preventive action as necessary. 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. Ensures complaints and feedback are recorded, tracked, and trended in QMiS. 4. Recommends and initiates corrective action and/or preventive actions to management as necessary. 5. Monitors the CFs in QMiS to ensure resolution is satisfactory and complete. 6. Reports on complaints and feedback highlights and trends at management meetings and during management review. 4. Background None For the most current and official copy, check QMiS. Title: FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II Document Number: ORA-LAB.4.8 Complaints and Feedback Revision #: 02 Revised: 05/15/2019 Page 3 of 6 5. 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) 6. 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 receives a complaint or feedback shall record it. The record can be made in the form of an email and entered into the QMiS CF form. 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 as a result of a complaint the corrective action procedure shall be initiated. Close out the complaint once the corrective action is closed out. B. If an opportunity for improvement is identified the preventive action procedure may be initiated. C. A qualified person must review complaints for possible failures and investigate where needed (AOAC 2018). A qualified person is an employee with technical knowledge of the product or activity area (for example dietary supplements and pharmaceuticals) of the complaint. For the most current and official copy, check QMiS. Title: FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II Document Number: ORA-LAB.4.8 Complaints and Feedback Revision #: 02 Revised: 05/15/2019 Page 4 of 6 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 another or multiple units. Follow SOP000116 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. Process Map For the most current and official copy, check QMiS. Title: FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II Document Number: ORA-LAB.4.8 Complaints and Feedback Revision #: 02 Revised: 05/15/2019 Page 5 of 6 Feedback Recieved Record Feedback Evaluate Yes or bo Elevate outside laboratory? Nonconformance? YES Follow SOP-000116 bO bO Take action to satisfy customer complaint YES Initiate Nonconforming Work/Corrective Action Process Record action taken Notify complainant of outcomes and completion of process, wOere possible Evaluate during internal audit and management review. 7. 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 in order to prevent reoccurrence. For the most current and official copy, check QMiS. Title: FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II Document Number: ORA-LAB.4.8 Complaints and Feedback 8. Records A. Complaint Feedback form B. Nonconformance Corrective Action form C. Preventive Action form Revision #: 02 Revised: 05/15/2019 Page 6 of 6 9. Supporting Documents A. ORA Laboratory Manual, Volume II, ORA-LAB.4.9, Control of Nonconforming Work B. ORA Laboratory Manual, Volume II, ORA-LAB.4.11, Corrective Action Procedure C. ORA Laboratory Manual, Volume II, ORA-LAB.4.12, Preventive Action Procedure 10. Document History Revision # Status* (D, I, R) Date 1.3 R 12/31/07 1.4 R 02/06/12 1.5 R 01/22/13 02 R 05/15/2019 * - D: Draft, I: Initial, R: Revision Author Name and Title LMEB LMEB LMEB LMEB Approving Official Name and Title LMEB LMEB LMEB LMEB 11. Change History Revision # 02 Change 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. 12. Attachments None For the most current and official copy, check QMiS.Onaghise, Osamede Adobe PDF Library 15.0