Putnam Plastics - Feedback and Complaint Handling Procedure PDF

Page 1 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024 1....

Page 1 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024 1. Purpose To ensure that customer feedback, including complaints, is handled in a timely, effective manner. 2. Scope This procedure applies to all Feedback received from Customers and describes the overall process for handling of that information. 3. Responsibilities 3.1. The Quality and Regulatory Affairs Department is responsible for, and owner of, this procedure. 3.2. Sales Representatives, Customer Service and Top Management, those who are in contact with customers, are responsible for communicating Feedback from customers. 3.3. Quality Specialist is responsible to initial recording of all Feedback and has oversight of the progress of the records until closure. 3.4. Quality Engineer (QE) is responsible for initial assessments, decisions for CAPA actions, further investigations, corrections and other activities to support this process as described below. 3.5. Quality Control Technician (QC Tech) is responsible for supporting QE activities. 3.6. Head of Quality and Regulatory Affairs Department approves closure of the complaint records. 4. Definitions Refer to Acronyms, Definitions and Terms (DMS # 020015). 5. Internal References 5.1. Acronyms, Definitions and Terms (DMS # 020015) 5.2. Corrective and Preventative Action (CAPA) (DMS # 1023) 5.3. PPC Terms and Conditions of Sale 5.4. Control of Non-Conforming Product (DMS # 1018) 5.5. Feedback & Complaint Module (DMS # 016708) 5.6. Rework/Sort Work Instruction (DMS # 1293) 5.7. Customer Feedback Disposition and Credit Request Form (DMS # 017794) 5.8. Root Cause Analysis (DMS # 1169) 5.9. Control of Records (DMS # 1005) 5.10. Records List (DMS # 1028) 5.11. Analysis of Data (DMS # 1020) 6. External References ISO 13485:2016, Medical Devices- Quality Management System Requirements Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. Procedure Template – # 020016 Rev 1 Effective Date: 2/5/2024  Page 2 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024 7. Process Map Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. Procedure Template – # 020016 Rev 1 Effective Date: 2/5/2024  Page 3 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024 8. Process Overview 8.1. All activities described in the steps below shall be recorded following Feedback & Complaint Module (DMS# 016708). 8.2. Open communication could take place between PPC and the Customer regarding the details or status of the Feedback or Complaint at any stage in the process described. 8.3. Communication with the customer regarding Complaints shall be documented. STEP # Who Action Input Those who have Input communication with New feedback from a Customer received and routed by email to PPC Customer customers Feedback Inbox ([email protected]) 1 Quality Specialist Record Feedback All Feedback shall be recorded following Feedback & Complaint Module (DMS# 016708). 2 Quality Specialist Complaint Decision All Feedback shall the reviewed to determine if the Feedback is considered a Complaint, refer to Acronyms, Definitions and Terms (DMS # 020015) or stays as Feedback only. NOTE: Product currently going through development shall be recorded as Feedback only. Decision Result: (i) If determined to be a Complaint:  Output: Acknowledgement of Complaint shall be communicated within 2 business days of receipt.  Output: A request for samples will be sent to the customer Continue to step 3 (ii) If determined not to be a Complaint and to stay as Feedback only: Continue to step 8 3 Quality Engineer and/or Initial Assessment Quality Control Technician Initial Assessment will be completed without undue delay (and this shall be considered investigation activities). This assessment will include the review of customer supplied samples*, product images, retains, work order records, past complaints or nonconformances of similar nature. The purpose of the initial assessment is to: (i) understand and document if the Complaint is verified or ‘not verified’ (also referred to as ‘unfounded’), and to (ii) identify the failure mode(s).  Consider if there were any deviations or any out of the ordinary scenarios during production.  Consider if there is any current inventory, if so, follow the Control of Non-Conforming Product (DMS# 1018) procedure.  Consider if the product (5P) previously was known as a different 5P.  Consider if an outside activity (or material) may have contributed to the Complaint.  Output: 3rd Party contacted with relevant information. *Customer does not need to return samples for initial assessment to take place. Continue to step 4 Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. Procedure Template – # 020016 Rev 1 Effective Date: 2/5/2024  Page 4 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024 4 Quality Specialist or CAPA Decision Quality Engineer A Complaint necessitates a CAPA based on the following criteria: (1) This is the 5th Complaint on this product with the same failure mode within the past 3 years, or (2) Otherwise decided by Top Leadership – the rationale for this decision shall be documented. NOTE: Top Leadership may decide, despite the point (1) above, a CAPA is not needed and the rationale for that decision shall be documented. Decision Result: (i) If determined a CAPA is required:  Output: Follow Corrective and Preventive Action (CAPA) (DMS # 1023), a reference to the CAPA shall be documented within the Complaint Record. Continue to step 9 (ii)If determined a CAPA is not required: Continue to step 5 5 Quality Specialist or Further Investigation Decision Quality Engineer After the initial assessment is complete, determine if further investigation is required. (1) Further investigation is NOT required when: a. The same subject/failure mode of the Complaint has already been investigated for the Product (Product Family) identified, or b. The subject/failure mode of the Complaint for the Product (Product Family) is representative of a known issue (for example, this could be inherent in the production process, or shown as present on the pFMEA), or c. The Complaint is determined to be ‘Not Verified’ or unfounded:  within defined specification, and therefore no longer meets the definition of a Complaint, or  The product is beyond the warranty period defined in PPC Terms and Conditions of Sale, or as defined in another contract or document, or d. Otherwise justified and rationale shall be documented. (2) Further investigation is required when, the above criteria is not met. Further investigation may still be conducted (with documented justification) based on more information and as a business decision. Decision Result: (i) If determined that further investigation is required, see point 2: Continue to step 6 (ii)If determined that further investigation is not required, see point 1: Continue to step 8 6 Quality Engineer and/or Further Investigation Quality Control Technician The purpose of the further, detailed investigation is to identify the root cause(s) for the found (and verified) nonconformance.  Use tools to conduct root cause analysis as described in Root Cause Analysis (DMS # 1169). Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. Procedure Template – # 020016 Rev 1 Effective Date: 2/5/2024  Page 5 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024  Consider reviewing the pFMEA to understand if this nonconformance has been accounted for as a possible hazard. Consider if the occurrence and/or detection rating(s) are appropriate.  Consider other department resources to support the investigative activities.  Consider if an outside activity (or material) may have contributed to the Complaint.  Output: 3rd Party contacted with relevant information.  Output: Root Cause identified Continue to step 7 7 Quality Specialist or CAPA Decision Quality Engineer A Complaint necessitates a CAPA based on the following criteria: (1) This is the 5th Complaint on this product with the same failure mode or root cause within the past 3 years requiring further investigation, or (2) Otherwise decided by Top Leadership – the rationale for this decision shall be documented. NOTE: Top Leadership may decide, despite the point (1) above, a CAPA is not needed and the rationale for that decision shall be documented. Decision Result: (i) If determined a CAPA is required:  Output: Follow Corrective and Preventive Action (CAPA) (DMS # 1023), a reference to the CAPA shall be documented within the Complaint Record. Continue to step 9 (ii)If determined a CAPA is not required: Continue to step 8 8 Quality Engineer Correction (1) Solutions to remedy the customer (if required) shall be considered, this includes returns*, fixed paperwork, additional product shipments, credit and/or scrap, use Customer Feedback Disposition and Credit Request Form (DMS# 017794) as needed, etc. *RMA # is the same as the record #, for example: “CF-1234”. (2) Correction activities may include customer requested actions or response to SCAR, and this shall be addressed according to customer requirements and all activities documented. (3) If no correction is needed, this shall be noted on the record.  Output: Correction Activities carried out Continue to step 9 9 Quality Engineer and Approval Head of Quality and RA At this step, the record is reviewed to ensure all activities are carried out with Department evidence and that the record is complete and routed for closure approvals. Output Quality Specialist Output Record Complete and Closed. Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. Procedure Template – # 020016 Rev 1 Effective Date: 2/5/2024  Page 6 of 6 Document Number: Revision: Level: Document Name: Effective Date: 1060 16 2 Feedback and Complaint Handling 7 Apr 2024 9. Records Records related to this procedure are maintained in accordance with Control of Records (DMS # 1005) and may be used as input for Analysis of Data (DMS # 1020). 10. Revision History Revision Date CCO # Description of Change Number (DD MON YYYY) Previous See revision history file in Document Control Revisions Added new form to reference docs Revised 3.3 to state The Director of Quality and Regulatory Affairs approves dispositions and credits for complaints. Determines when a CAPA is opened. 14 28 Oct 2019 2485 Added New responsibilities for President, CEO and Director of Sales. Revised 7.8.2 and 7.6 to include the use of the new form and who is responsible to approve. Updated flow chart Appendix 1 - Removed 4.4. from Required documents section - Revised 7.2 to remove checklist requirement 15 30 Dec 2021 3455 - Revised section 7.8.2 - Removed 7.10.1 - Updated Appendix 1 1) Updated to use new SOP template/format 2) Changed title from “Customer Complaint Process” to “Feedback and Complaint Handling” 3) Conducted gap assessment to review against requirements of ISO 13485:2016. As a result, added in sections: a. Step 2 to include the necessity for determination if Feedback constitutes as a Complaint (ISO 13485:2016 Section 8.2.2 (b)). Giving tools, by definition, and internal definition: must be production product and not considered as development product. b. Step 4a to include the necessity of justification if no investigation is conducted (ISO 13485:2016 Section 8.2.2). c. Step 8, to include how to determine the need to initiate a 16 7 Apr 2024 4645 CAPA (ISO 13485:2016 Section 8.2.2(f)). d. Step 3a and 5a to include the necessity to contact a 3rd party with relevant information, if, as a result of investigation activities, the 3rd party is determined to have contributed to the nonconformance from which the complaint is started (ISO 13485:2016 Section 8.2.2). 4) Removed definitions to instead reference a master Acronyms, Definitions and Terms document. 5) Reworded responsibilities section to include the mention of roles instead of titles. 6) Reworded and re-ordered section to improve and give direction on the sequence of actions within the overall process. Refer to redlines for more details. Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. Procedure Template – # 020016 Rev 1 Effective Date: 2/5/2024