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corrective action (ca)

  1. I

    Audit Nonconformances - Can reported corrective actions be incomplete?

    If you receive non-conformances during an audit, then you need to report back within a certain time frame on the corrective actions. Do the corrective actions need to be completed when you report back or can they be in-process (i.e. ongoing)?
  2. I

    Corrective Action Tracking for Product and Process in the same system?

    I've worked in two different environments that were ISO-9001 compliant. In the first one, we tracked only PROCESS non-conformances in one tracker and PRODUCT nonconformances were tracked in a defect tracking system. I don't see any guidance in the standard on this and my instinct is to fall...
  3. E

    ISO 9001:2105 - Are OFI or Corrective actions required?

    Hi All, Our continual improvement processes cover our Corrective Action processes/records, but we have no processes in regards to Corrections or OFI (Opportunities For Improvement). We're a small company with limited resources and are relatively new to ISO so are trying to walk before we run...
  4. G

    When preventative action is prohibited by cost in 8D problem solving

    What happens when preventative action is prohibited by cost in 8D problem solving?
  5. R

    CIP (Corrective Action) requirements - ISO 9001 clause 10.2

    Question on a topic that i was advised on by my QMS help desk person. So we had a finding on Clause 10.2 stating that corrective actions (CIP)s do not always have evidence of investigation and cause analysis results recorded. Now if one was just no plating on parts that required plating. Having...
  6. E

    CAR (Corrective Action Request) Due Dates

    Hi All, Super simple question from a new quality manager. We keep a CAR spreadsheet to keep track of all open CARs. I understand we need to close all CARs in a timely manner typically 1 month from initiation. My questions becomes what qualifies as closing a CAR? It seems like there are 3...
  7. Q

    Is a Corrective Action Expected if a Quality Objective is not in compliance?

    Hello Everyone In the task of revising the compliance of the quality objectives, and considering that top management approved such objectives, In the next example : One objective (reduction of rejected product) now resulted no compliant. The question is: should a CA be raised...
  8. M

    Corrective Action Effectiveness

    Looking for input on how you measure the effectiveness of my correction action system. We issue a CAR, then the owner has 24 hours for containment, 5 days for the corrective action plan, then permanent correction action is due in 14 days. I need idea on aging reports for each step (not...
  9. P

    Documentation for correction, corrective action, mini CAPA

    :confused: Hi, Correction is an action to eliminate a detected nonconformity; Corrective action is an action to eliminate the root cause. I get that. I think ;) Is there a "mini corrective action" situation? example (of a frequent occurrence): A customer required a CAPA for a part that...
  10. Uriel Alejandro

    Evaluation of the effectiveness of correction actions

    Hello Everybody, I´m making some updates to my corrective actions procedure and during this process I´m having some problems trying to define a correct method for the evaluation of the efectiveness of a implemented action. I the past, I managed to solve the effectiveness requirement...
  11. pziemlewicz

    Interesting Read Addressing Human Factors in Corrective Action

    In a recent AS9100D audit, I received one minor NCN: Need to better document how we're reviewing/addressing human factors within the corrective action process. Does anyone have a suggestion of something that works? Has someone seen a customer corrective action request form with an area to...
  12. S

    Formal written response to a corrective action?

    Does anyone know of any training for how to write/respond to a corrective action?
  13. M

    Informal Corrective Actions - AS9100DCl. 10.2.1 A-H

    I am looking to put into a corrective action procedure the ability to do an 'informal corrective action' (I cannot think of a better term). The concept behind this is not every problem that arises needs a formal documented corrective action and someone can fix the problem without spending time...
  14. A

    CAR from 3rd party AS9100D auditor - Root cause dilemma

    Short explanation. Had transition AS9100D audit, finished last Friday. We had not audited to the new standard. Received a minor nonconformance for not auditing to the new standard. Internal CA issued for me to address. I am the audit coordinator. Last year, January thru May, our Quality...
  15. Q

    AS9100D Corrective Action Procedure needed

    QA Pros: Can some one share an AS 9100D corrective action procedure? thank you
  16. S

    Corrective Action from Internal Audits not performed

    We did not complete all of our planned audits for the previous audit cycle. There were several issues, but it mainly came down to we had too many planned for the manpower we have performing the audits. Our auditor is now telling me that part of the corrective action plan is that all of those...
  17. J

    We don't have enough Corrective action entries

    I work in a small AS9100D certified machine shop/plastic production shop, and our work is pretty consistent and basic. We don't encounter too many problems and things generally run smoothly. Because of this, we do not have many entries into our corrective action system (27 over the course of...
  18. T

    Timely Closure and "Ongoing" Corrective Action

    Just started at a new company and reviewing management review. There is a 2 year old corrective action that is 'on-going'. I don't like seeing the 'on-going' word on any corrective action. It should have a quick end date, or shouldn't it?
  19. P

    Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis

    We are an ASME Pressure Vessel manufacturing and repair service company in the petrochemical arena. Recently we have decided to improve our QMS to include a formal NCR, CAR and Root Cause analysis program. MY back ground is in the field installation but have had some limited training in the...
  20. O

    Updating "opportunities" resulting from Corrective Actions

    Referencing ISO 9001:2015 10.2 Nonconformity and corrective action, what would be examples of or the types of "opportunities" needing to be updated? I get updating the "risk" aspect. Thanks
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