CAPA effectiveness check

#1
I have a CAPA open that involves an attribute test resulting in P/F. The root cause was identified and corrective action applied. During the effectiveness check of this CAPA, 504 parts were tested to result in a 99% confidence that the population of non-defective is at least 99.0904%. When the testing was performed it was identified that 2 units failed due to an issue outside the scope of the initial CAPA.

So the parts are passing but due to another issue, that has since been eliminated, 2 failed. Would this change the results to 2 failures out of 504 units? Or can it be written as 502 units with 2 removed. I am asking because the corrective action is clearly effective yet it seems there was another root cause that resulted in failure.

Thoughts?
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
exactly Tagin. The two units that failed for an unrelated cause did not fail for the cause in question so they still belong in the calculation...
 
Thread starter Similar threads Forum Replies Date
B Lead Auditor Assigned to Effectiveness Check - CAPA Internal Auditing 14
N How to monitor the effectiveness of the CAPA system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Effectiveness Plan for CAPA initiated from External Audit US Food and Drug Administration (FDA) 3
K Effectiveness of CAPA in this Safety Situation Nonconformance and Corrective Action 8
J CAPA Effectiveness Checks on Low/No Volume Processes Nonconformance and Corrective Action 7
L Verification of Effectiveness of CAPA Nonconformance and Corrective Action 23
A How to verify and validate the effectiveness of CAPA with regards to employees ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A CAPA - Reasonable Timeframes for Effectiveness Evaluation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
L Verification of the Effectiveness of a CAPA ISO 13485:2016 - Medical Device Quality Management Systems 9
R CAPA Effectiveness Review vs. Re-Audit Misc. Quality Assurance and Business Systems Related Topics 3
J Medical Device CAPA Questions on Timeframes and Effectiveness Reviews 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Taking credit for CAPA Effectiveness Audits as Internal Audits Nonconformance and Corrective Action 4
J CAPA (corrective action preventive action) Effectiveness - Medical Device Industry Nonconformance and Corrective Action 3
E Audit Program and CAPA (Corrective Action - Preventive Action) Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Nonconformities and CAPA Nonconformance and Corrective Action 9
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
F NCMRs and its relation to CAPA Nonconformance and Corrective Action 7
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
B CAPA - Extensions vs Overdue Nonconformance and Corrective Action 11
G New CAPA Work Flow with Revised 8D Approach Process Maps, Process Mapping and Turtle Diagrams 35
Y Blank Fields on CAPA Form Document Control Systems, Procedures, Forms and Templates 21
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
Ed Panek CAPA against Notified Body? EU Medical Device Regulations 5
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
Q Raising A CAPA on Current CAPA system US Food and Drug Administration (FDA) 3
Z Security for Approvals - Cloud based Complaint, NC, and CAPA systems Qualification and Validation (including 21 CFR Part 11) 8
S FDA requirements and CAPA's Qualification and Validation (including 21 CFR Part 11) 2
J MDR reporting and CAPA thoughts? Classifying Complaints on Risk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
P Documentation for correction, corrective action, mini CAPA Nonconformance and Corrective Action 9
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
A Can change control can be closed if the CAPA is still open? Nonconformance and Corrective Action 3
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A NCR, NCMR, CAPA, Deviations - Medical Device Distributor Nonconformance and Corrective Action 2
S CAPA Investigation Methods Nonconformance and Corrective Action 3
qualprod Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
J CAPA and other Log Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
D Any Elsmar members using Traqpath to manage CAPA? Nonconformance and Corrective Action 2
D CAPA - Suggested Action vs Action Plan Nonconformance and Corrective Action 5
A Audit Finding - CAPA, Improvement Initiatives not filed in CAR System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Moncia Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Issue with CAPA system - Should Over Due CAs warrant a CAPA? Nonconformance and Corrective Action 17
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
M CAPA due to Consumer not following Maintenance Instructions... Nonconformance and Corrective Action 9

Similar threads

Top Bottom