capa (corrective and preventive action)

  1. G

    Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions

    I'd appreciate people's thoughts on the following regarding how/what system our medical device company uses for NMRs, CAPAs, corrections, corrective/preventive actions... As the head of Quality for my company, I hold regular meetings with influential members of my organization to discuss...
  2. Q

    Raising A CAPA on Current CAPA system

    Hi guys Ive recently moved company and already implemented a new NCR process as it wasn't fit for purpose. I have raised a CAPA on the current CAPA process as again this is not fit for purpose. My CAPA scope/Justification is as follows; The reliability of the current CAPA process and...
  3. S

    FDA requirements and CAPA's

    Hello all Does anyone know if the FDA has a requirement for a non-conformance to have a formal and documented risk or potential impact assessment in all CAPAS for GMP work? Thanks in advance
  4. P

    Quality objectives - must they include CAPA and internal audit topic?

    Hi all, Just finished hosting an ISO 13485:2016 audit with a registrar. :bonk: The auditor wrote a non-conformance for not having quality objectives in the "CAPA" and "internal audit" areas (although these topics were presented in the management review). Is it mandatory to have these...
  5. A

    Can change control can be closed if the CAPA is still open?

    Hi, Can anyone please confirm if the change control can be closed if the CAPA is still open? Regards
  6. A

    NCR, NCMR, CAPA, Deviations - Medical Device Distributor

    Hello!! I work in a Medical Device company, they don't manufacture just distribute. They consider production as being part of the distribution team.. anyway to give you an idea of what I'm a little confused about: they do NCRs and NCMRs mainly for packaging/labeling, if a label needs...
  7. S

    CAPA Investigation Methods

    Hello, I am looking for some CAPA Investigation Method descriptions that you might have created. We have people who are investigating CAPAs, and are not well trained on the use of investigation methods, like 5 Why, Cause and Effect Diagrams, Is Is Not Maps, etc. Any assistance would be...
  8. S

    My department inherited a large number CAPAs

    Hi everyone. Thanks for all the helpful advice on this forum. My department inherited a large number CAPAs from the previous regulatory/quality staff. There are 4 categories 1. Issues misidentified as CAPAs. 2. CAPAs with no effectiveness verification 3. CAPAs with incomplete...
  9. Q

    Should I initiate CAPA for a nonconformance not recorded?

    Hi everybody, From the perspective of an auditor: If a have certification audit with external people (in short) And internally I have an nc, and I Know about it. Could I carry out an internal audit, identify the nc and raise the CA of this known nc? This way if the external audit, detect the...
  10. J

    Using Complaint Rate to Update FMEA P.O.C

    I am looking for some information and guidance on how to properly analyze a need to update an FMEA POC based on the rate of complaints received. My specific situation at the moment is that I have a complaint lodged that relates to an identified risk. The risk was assigned a severity of 2...
  11. S

    Would a wrong definition constitute an Audit Finding?

    In one of our procedure, the definitions of CA and PA were interchanged. Would this constitute a finding and if yes, against which clause of ISO 9001:2008?
  12. R

    CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence

    Hi All, I am curious as to how members here are going about meeting the requirement for verifying CAs and PAs do not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device (8.5.2 e) and 8.5.3 d))? Do auditors want to see a...
  13. J

    CAPA and other Log Requirements

    Hi Everyone, I recently had an ISO 13485 Audit and the auditor gave me a Cat 3 finding (opportunity for improvement) that "The firm does not keep a traditional CAPA Log, but there is evidence of active tracking of CAPA performance both at management reviews and in Quarterly Data Analysis...
  14. Document Dame

    CAPA - Suggested Action vs Action Plan

    What’s the difference between a Suggested Action and an Action Plan in a CAPA? At the top of our CAPA form there’s a Suggested Action: field. After filling in the Root Cause, there’s an Action Plan: field. I seem to be repeating the same information. I would appreciate it if...
  15. Moncia

    Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience

    Hello We need to tighten up our control of non-conforming product procedure. From the beginning - customer complaint to the corrective action validation. Please share your experience and samples. Where one ends and another begins? Your input will be greatly appreciated. M. :thanx:
  16. M

    Issue with CAPA system - Should Over Due CAs warrant a CAPA?

    Hello,:bigwave: So we have several CAPA's that are severely past due, and we want to assign a CAPA to address the current problem. While some people in my company agree that this is good practice to show the FDA that we noticed a gap in our system and we are addressing it, others seem to think...
  17. K

    CAPA (Corrective and Preventive Action) - ISO 13485

    CAPA for ISO13485: It has come to my attention that companies are opening corrective actions and during investigation, it's found other potential potential issue pertaining to the original non conformance could occur, so they open a preventative action and reference it on the corrective...
  18. M

    CAPA due to Consumer not following Maintenance Instructions...

    Hello,:bigwave: My company has an open Corrective action. The non-conformance was: End User/Consumer failed to follow the battery charging instructions in the operating instructions and Maintenance Manual. I need to complete/close this CA and would like to know how you have handled similar...
  19. P

    Trending CAPA's in our Management Review Meetings

    Does anyone has a sample management review work instruction? I am planning to trend CAPA's in our management review.
  20. J

    Software and Methods for Tracking CAPA (Corrective and Preventive Action) items

    What software do you use to manage internal inspection findings and responses to findings? I would like to be able to track findings, response to findings including commitments to CAPAs made by operations (e.g., will write and implement SOP x by date y), to trend finding types (e.g., are the...
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