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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?
Which of the following standards does this procedure reference?
Which of the following standards does this procedure reference?
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?
Which document number corresponds to Complaint Handling?
Which document number corresponds to Complaint Handling?
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What is included in the scope of the procedure?
What is included in the scope of the procedure?
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What is the primary responsibility of Product Success?
What is the primary responsibility of Product Success?
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How are customer complaints regarding product quality handled?
How are customer complaints regarding product quality handled?
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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?
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What is the purpose of the feedback system as described?
What is the purpose of the feedback system as described?
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Which of the following sources is NOT used for collecting feedback information?
Which of the following sources is NOT used for collecting feedback information?
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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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Description
This quiz covers the quality assurance procedures as outlined in the Compass Health Al SOP. It includes aspects of customer feedback gathering, satisfaction measurement, and applicative ISO standards. Understand the roles, responsibilities, and relevant documentation for ensuring product quality.
