Podcast
Questions and Answers
What is the primary purpose of the procedure outlined in the document?
What is the primary purpose of the procedure outlined in the document?
- To streamline manufacturing processes
- To gather and analyze post-production feedback (correct)
- To enhance product delivery methods
- To implement new quality assurance regulations
Which of the following standards does this procedure reference?
Which of the following standards does this procedure reference?
- ISO 14001:2015 Environmental Management
- ISO 9001:2015 Quality Management Systems
- ISO 45001:2018 Occupational Health and Safety
- ISO 13485:2016 Section 8.2.1 Feedback (correct)
What types of records fall under customer feedback records according to the document?
What types of records fall under customer feedback records according to the document?
- Customer complaints and product satisfaction surveys
- Market research reports and sales records
- Warranty claims and product specifications
- Clinical evaluation reports and product nonconformity reports (correct)
Which document number corresponds to Complaint Handling?
Which document number corresponds to Complaint Handling?
What is included in the scope of the procedure?
What is included in the scope of the procedure?
What is the primary responsibility of Product Success?
What is the primary responsibility of Product Success?
How are customer complaints regarding product quality handled?
How are customer complaints regarding product quality handled?
What role does the Quality Assurance - Regulatory Affairs (QA-RA) play in customer feedback?
What role does the Quality Assurance - Regulatory Affairs (QA-RA) play in customer feedback?
What is the purpose of the feedback system as described?
What is the purpose of the feedback system as described?
Which of the following sources is NOT used for collecting feedback information?
Which of the following sources is NOT used for collecting feedback information?
Flashcards
Feedback System
Feedback System
A structured process for gathering, analyzing, and utilizing customer feedback regarding products, services, and overall experience to improve quality and enhance satisfaction.
Customer Feedback Records
Customer Feedback Records
Customer feedback records are documents that capture customer complaints, product issues, clinical evaluation results, and other information related to customer satisfaction.
Customer Satisfaction
Customer Satisfaction
The degree to which customer expectations are met or exceeded by the product or service, often assessed through surveys and other measurement tools.
Analysis of Customer Feedback
Analysis of Customer Feedback
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ISO 13485
ISO 13485
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Customer Feedback
Customer Feedback
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Customer Success Role
Customer Success Role
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Customer Complaints
Customer Complaints
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Control of Nonconforming Product
Control of Nonconforming Product
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Study Notes
Approvals
- Compass Health Al SOP: Feedback document
- Tenzin Yangzom (Head of QA/RA) was the author, and the document was dated 02-Jan-2024
- James Baskin (COO) was the approver, and the document was dated 02-Jan-2024
Revision History
- Version 1.0
- Initial Release date 03-Jan-2024
1 Introduction - Purpose
- This procedure provides a system and instructions for gathering customer feedback and determining customer satisfaction
- It assigns responsibilities for analyzing post-production feedback and providing early warnings of quality problems
- It supplies input into corrective and preventive action processes
1 Introduction - Scope
- The procedure covers products, delivery, servicing, and activities impacting customer satisfaction
2 Applicable Documents - Standards
- ISO 13485:2016 Section 8.2.1 Feedback is addressed
- TG(MD)R Sch1 P12, Sch3 P1 1.4(3), 1.4(5)(b)(iii) & 1.4(5)(f) are mentioned
2 Applicable Documents - Reference Documents
- SOP: Management Review (QMS-SOP-0004)
- SOP: Control of Non-Conforming Product (QMS-SOP-0024)
3 Acronyms and Definitions
- Customer feedback records: Customer complaints, product nonconformity reports, clinical evaluation reports, and associated records
- Customer satisfaction records: Customer complaints and other related records
- Epic: Product requirement identified and refined by collaboration with industry practitioners, potential customers, and internal market analysis
- Idea: Feedback/design suggestions from internal and external users
4 Process Roles
- Product: Responsible for reporting significant feedback on products or customer satisfaction, using feedback as input for risk management, and maintaining product requirements
- Customer Success: Reviews and reports on feedback and customer satisfaction, handles complaints/returns and coordinates data collection
- QA-RA: Coordinates feedback collection and customer satisfaction results. Reports on non-conforming product trends, and complaints
5 Customer Feedback Procedure
- The feedback system gathers and analyses post-production performance to identify early warning signs of quality problems
- Feedback is collected from customer complaints, and analyzed per SOP: Complaint Handling
6 Process Monitoring
- Cross-functional teams analyze customer satisfaction data (various sources)
- Results are presented to executive management at Management Review meetings
- Data is used to compare current performance with previous years and projections.
- Objectives are set for the current year, using the analysis for input into risk management and product requirements
7 Quality Records
- Complaint Logs: Electronic log documenting all customer complaints, with supporting documentation and complaint numbers
- Product Returns: Report detailing product returns reason, classified into categories used for customer complaints
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