The verification of effectiveness of corrections and corrective action is an important part of:
- Eliminating the causes of nonconformities
- Minimizing the likelihood of its recurrence
The verification process must include all corrections to the quality management system resulting from your investigation, including the identified root cause.
To complete this task, you must ensure that appropriate corrections have been made and that a true root cause has been identified.
In many cases “corrections” typically take the form of:
- Revising a document (e.g., procedure, work instruction, form)
- Creating a new document
- Having an inspection and measuring device calibrated (e.g., if it was late for calibration)
- Placing a tag on an inspection and measuring device (e.g., if the tag fell off)
- Making purchasing information more detailed (e.g., adding the industry specification affiliated with ordering an API Spec 7-1, R2020 PDC Bit)
Corrections must be concrete and be able to demonstrate that an activity took place to make the fix or fixes.
As part of the verification process, you must ensure that the correction for the condition identified as the root cause is also tangible. Think of it as the one thing that could have been in place prior to the audit that would have prevented the nonconformity from ever occurring. Sometimes the 5-why process isn’t effective in diving deep enough to discover the real issue.
The following examples could fit that definition:
Example 1:
- While we had a documented procedure in place (document number___, revision level __ to revision level __) it was not robust enough to highlight the specific condition of the nonconformity.
Part of the correction action could state:
- Revised the procedure from Rev. __to Rev.____
- Included a matrix that illustrated the potential conditions that could occur (as determined from historical data)
Example 2:
- While we have routinely scheduled the internal audits through our audit plan, we did not have a company-wide calendar that showed recurring quality events.
Part of the corrective action could state:
- We created a company-wide quality calendar
- A feature to identify recurring dates is included in the calendar
- Management and Quality Personnel have access to the calendar and are reminded of these events
Remember, the corrective action is something, new or additional, that would eliminate the issue from coming up again in the future.
Root causes such as the “lack of training” or “the process step was missed” are more of an admission that the quality management system wasn’t working than an actual correction.
Subsequently, corrective action must be identified for every correction identified. The overall corrective action process will address the specifics; however, it should also consider the following points:
- The following documents were revised… (document number___, revision level __ to revision level __)
- The following documents were created… (document number___, revision level)
- Perform training on the aforementioned:
- Revised documents…
- New documents…
- Implementation was satisfactorily completed
- Training effectiveness was verified and found to be effective
- Corrective Action implementation was found to be effective. Evidence of the samples used to determine effectiveness were recorded on the CAR form
- The Corrective Action report was subsequently closed.
Upon the completion of the correction and corrective action process as defined above, the determination of effectiveness can begin by examining objective evidence (created through the correction and corrective action processes).
The following activities will help you to clearly document your determination that each nonconformity was effective:
- Create an evidence package for each response. Include evidence of all the points identified in each CAR response.
- This can be done electronically or hard copy
- Associate any Risk Assessments and/or Management of Changes that were created during your evaluation of what led to the initial nonconformity and/or found during implementation of the CAR
- For example: a MOC for any software changes and retesting of the software prior to implementation to ensure that the software meets internal requirements and its intended purpose
- Be sure to identify the objective evidence, obtained through sampling, was reviewed that led to your determination that the implementation of the CAR was effective. Evidence could include, but is not limited to:
- Procedure #, Title, Revision Level
- Individual’s names and titles
- Title, Date of Training Sessions, including Instructor’s Name/Title on the training record
- Order numbers and dates
The best way to check for effectiveness is to review the implementation of each corrective action after a specified period. Sufficient time must be given and verification must occur prior to closing the corrective action. If the corrective action is not effective, it should be reevaluated until such time it is effective, revised and its implementation reverified.
Remember, prior to closing out a Corrective Action Report, all responses should be in the past tense. Closure should have also occurred within the period identified in your quality management system.
