CAPA-related QSR requirements are quite far reaching. If you are coming from a manufacturing background, CAPA is conceptually similar with Six Sigma’s DMAIC methodology (Define / Measure / Analyze / Improve / Control) with a few key differences.
Under Six Sigma or Lean, the ultimate goal is usually a desired improvement in capability, cost position, or operational effectiveness. Under 21 CFR Part 820 (QSR), the goal of CAPA is to ensure early identification, removal, and preemption of systematic process non-conformances potentially affecting safety and / or effectiveness of clinical therapy, monitoring, or diagnosis. In other words, Six Sigma drives operational profitability (immediate shareholder focus) while CAPA drives safety and clinical effectiveness (immediate regulatory focus) -- arguably still a path towards profitability, although not necessarily in and of itself.
Back to the question - to be compliant with the QSR, your CAPA system must have adequate procedural and operational coverage for the following five key elements:
1. Comprehensive “data feeders” covering your company’s entire set of “touch points” with the external environment (or their proxies): complaint logs, MDR investigations, service, manufacturing, industry publications, internal or external audits, previous CAPAs, engineering reviews, supplier audits, incoming inspection of parts and materials, customer call rates, Top X rates, etc. with specific triggers (or “normal limits”) defined for each feeder.
2. Feeder status reviews (monthly?) to identify deviating trends early. Data mining and cross-correlation analysis are useful tools that should be considered. Once a trend indicating a possible non-conformity is identified, what is the risk to safety and / or clinical effectiveness? Based on the identified trend and specific risk, should a CAPA be raised? Should a recall be initiated? Should a customer letter be triggered?
3. Formal CAPA planning process with the following activities:
a. CAPA definition, symptoms, risk assessment, impact assessment
b. Formal Root Cause Analysis. FMEA, FMECA, FTA, etc. are all useful tools to be considered.
c. Corrective Action to eliminate the non-conformance. Might be procedural, training, labeling, design-based, process change, etc. Might include verification and validation activities as appropriate.
d. Preventative Action to prevent this and similar non-conformities from occurring in the future.
e. CAPA Effectiveness study to evaluate the effectiveness of the removal of root cause and of the prevention of this and similar non-conformities from reoccurring.
4. CAPA management and aging review at the most senior level possible, to ensure visibility, resource availability, and prioritization for a risk-adjusted timely resolution of all active CAPAs
5. Formal CAPA documentation process to capture and document all CAPA-related activities executed, inclusive of management reviews
Each situation and each company is, of course, different. To address your specific situation, please visit ww.priusmedical.com for further details.
Under Six Sigma or Lean, the ultimate goal is usually a desired improvement in capability, cost position, or operational effectiveness. Under 21 CFR Part 820 (QSR), the goal of CAPA is to ensure early identification, removal, and preemption of systematic process non-conformances potentially affecting safety and / or effectiveness of clinical therapy, monitoring, or diagnosis. In other words, Six Sigma drives operational profitability (immediate shareholder focus) while CAPA drives safety and clinical effectiveness (immediate regulatory focus) -- arguably still a path towards profitability, although not necessarily in and of itself.
Back to the question - to be compliant with the QSR, your CAPA system must have adequate procedural and operational coverage for the following five key elements:
1. Comprehensive “data feeders” covering your company’s entire set of “touch points” with the external environment (or their proxies): complaint logs, MDR investigations, service, manufacturing, industry publications, internal or external audits, previous CAPAs, engineering reviews, supplier audits, incoming inspection of parts and materials, customer call rates, Top X rates, etc. with specific triggers (or “normal limits”) defined for each feeder.
2. Feeder status reviews (monthly?) to identify deviating trends early. Data mining and cross-correlation analysis are useful tools that should be considered. Once a trend indicating a possible non-conformity is identified, what is the risk to safety and / or clinical effectiveness? Based on the identified trend and specific risk, should a CAPA be raised? Should a recall be initiated? Should a customer letter be triggered?
3. Formal CAPA planning process with the following activities:
a. CAPA definition, symptoms, risk assessment, impact assessment
b. Formal Root Cause Analysis. FMEA, FMECA, FTA, etc. are all useful tools to be considered.
c. Corrective Action to eliminate the non-conformance. Might be procedural, training, labeling, design-based, process change, etc. Might include verification and validation activities as appropriate.
d. Preventative Action to prevent this and similar non-conformities from occurring in the future.
e. CAPA Effectiveness study to evaluate the effectiveness of the removal of root cause and of the prevention of this and similar non-conformities from reoccurring.
4. CAPA management and aging review at the most senior level possible, to ensure visibility, resource availability, and prioritization for a risk-adjusted timely resolution of all active CAPAs
5. Formal CAPA documentation process to capture and document all CAPA-related activities executed, inclusive of management reviews
Each situation and each company is, of course, different. To address your specific situation, please visit ww.priusmedical.com for further details.
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