When nonconformities are identified during an off- or on-site assessment, Platinum Registration will ask that you take appropriate actions to address the root causes of the issues so that you stop them from occurring again. This document has been developed to facilitate this corrective action process and to make our expectations clear so that you can be confident that the actions that you take and the evidence that you provide will be accepted.
What happens when a nonconformity is identified?
When a nonconformity is identified, your assessor will bring it to your attention during the assessment and will record it on a Nonconformance Table.
Your assessor will request that you use your corrective action system to track, evaluate and record the actions that you take to address the nonconformance and to provide evidence of the corrections, corrective actions and verification activities within 30 days of receipt of your assessment report.
Please document your actions in the manner that you would document them for a client or a person independent of the assessment (our reviewers will need to be able to understand your assessment and actions without having been at your facility to see the problem).
What do you need to do in response to a nonconformance?
- Assess the nonconformance – evaluate the nonconformance as it was presented by your auditor to ensure that you understand the requirement and the objective evidence provided. If you question the validity of the nonconformance or need clarification, please bring your questions to the attention of your auditor first. If you are still not comfortable with the nonconformance, please bring the situation to the attention of Platinum’s management. We want to make sure that you understand the nonconformance before you spend time working on corrective action. To assure that you provide the evidence that is required, please transfer the wording of the entire requirement and the nonconformity (as provided in the Nonconformance Table) to your corrective action system. Do not paraphrase the wording used by the assessor to prevent any confusion or mistakes in addressing the identified issue.
- Perform root cause analysis – This is the analysis of the problem to determine its underlying cause or causes. It is imperative that you dig deep to determine the actual causes. Some people find asking why did this occur five or more times to get to the actual root cause. It is not acceptable to say “we forgot” or that “we were not aware”. Both of these responses are not taken down to the actual cause. What in your management system allowed you to forget or not be trained? So ask why did our system let this happen – at least five times. Also realize that some problems are complex and may have several root causes.
- Make Corrections – Corrections are short term fixes to address the immediate nonconformity. (Adding a missed record to your record retention form, adding a missed signature, performing a missed inspection or audit, for example.) Make sure that you address the problem identified by the assessor as well as any similar problems. For example, if your assessor identifies that a training record was missing for a specific employee – it is your responsibility to review the records for your other employees to assure that they are all in place as intended – not just create the missing record for the employee identified by the assessor.
- Take corrective action – Corrective action is the action taken to correct the root causes of the of the problem to assure that the problem will not repeat itself. It generally focuses on the management system itself.
- Verify the of effectiveness of actions taken – This action is the activities that you perform to assure that the correction and corrective actions taken were effective in addressing the problem as well as the cause of the problem.
- Send Platinum evidence of activities taken – This evidence includes: Your corrective action form identifying the problems, root cause analysis, correction, corrective action and verification. In addition to supporting what you checked to assure that the action taken was effective in addressing the cause of the problem. Examples could include revised documents, revised records, evidence of training, calibration, audits, etc.
How do we prepare a corrective action plan?
Where evidence of a system exists but nonconformities or inconsistencies were found in the system and in order to correct the problem effectively, the action is likely to take longer than 30 days; a plan of corrective action will be requested. The rationale for this is that we do not want to encourage inappropriate actions simply to close the nonconformity in order to obtain or maintain registration.
In such situations (as agreed with your Lead Auditor), then please provide us with a plan for that action using the form provided and follow through with the corrective action using your corrective action system when it is appropriate to do so. We will review the corrective action plan to determine if the plan will effectively address the nonconformity. We will review the corrective action during our next visit to assure that the corrective action was effective.
How do we submit the corrective actions?
Please send all of your corrective actions at once, rather than trickling them into the office. This makes it easier for the auditor and office to plan for the review of the actions.
Each corrective action should be submitted in segregated files so that it is easy to identify what corrective actions and supporting documents go with each nonconformance identified.
This makes our administration and evaluations of your corrective actions efficient and keeps our administrative costs as low as possible for our clients. Failure to submit corrective actions in this manner will result in our rejection of the corrective actions until they are submitted in this format.
For example – your Platinum auditor identifies 3 Nonconformances – they are labelled Nonconformance 1, Nonconformance 2 and Nonconformance 3 on your Nonconformance Table:
You will submit one zipped file containing the following:
Three files labelled NC1, NC2, NC3
In each file – you will ad:
- A copy of your corrective action form (you may call it something else – but it should minimally identify the requirement, the problem, the root cause, the corrective action and the verification of the action for effectiveness.)
- Supporting records to demonstrate the actions taken. These may include minutes, training records, calibration records, etc. depending upon the nature of the problem.
What do we do if we are unsure of the action to take?
If you are unsure of the action to take, please contact us before investing any time or energy in addressing the issue. We can certainly provide clarification of the problem and while it doesn’t make sense for us to tell you what is best for your organization, we are happy to advise on the conformance of your proposed solutions.