Management of Nonconformity
The effective management of nonconformities has always been an uphill task for me and my team. We capture the NCs quite alright, initiate investigations and corrective methods. But the continuous monitoring and follow up to ensure effectiveness of the corrective action and also prevent reoccurrence has always been a challenge. Is this topic addressed in SLMTA 3 e-learning course or is there another course for it? Because I really need to acquire the skills to break this challenge.
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To Nicoline
We will be covering this subject in QMS 4. I am going to give some advice here, but please bring your questions to the office hour prior to management of NCE .
When a NCE is written and the corrective action taken, state in your process what time frame you will give to monitor effectiveness. I usually suggest 3 months. Some CA may take longer to show implementation so those could be checked at the next audit. You can look at it like this when it comes to audits. Internal audit - NCE raised- CA taken- 3 months later - check effectiveness - next Internal audit/External audit - no NCE raised - CA is effective. If the NCE raises its head again, then start the CA process afresh. You can also add a corrective action effectiveness audit into your internal schedule,
Janet
I also suggest that you closely track the re-occurrence of those particular non conformities during the subsequent internal audit. That is one way you can check for the effectiveness of those corrective actions. Another way can be from subsequent staff or customers complaints or suggestions for improvement about that particular non conforming event.
Thanks Janet, I look forward to that.
Thanks, Elisabeth.
You could possibly consider scheduling the evaluation of effectiveness of the corrective action using a suitable checklist. For instance,if you have given yourself 3 months of checking the effectiveness of the corrective action then you can schedule monthly evaluations with the appropriate checklist. This has the advantage of swiftly identifying and addressing corrective actions which:
1. have not been implemented
2. Have resulted in negative or unintended consequences.
Route course analysis is the most tricky part in handling nonconformities. Ones route course is clearly indicated, the other processes are easier to execute
@Jacqueline Mukhaye Amira in QMS 4, you will learn how to do Root Cause Analysis.
Thank you, Kuda.
I agree with you, Jacqueline.
Great, Katy. I look forward to it.
for unforunately most of NCE resluted from non- compliance ( should we consider compliance is not extra work,it should be fit with in the process)
some NCE are recurrent and beyound the lab level making it very difficult to evaluate the effectiveness of the corrective action .
I concur with your last accession John. My laboratory has also experienced recurring NCs that are outside the control of the lab particularly pertaining to stock outs.
When an external factor impacts on your laboratory system e.g supplier does not have raw material for instance and cannot supply the laboratory. Make sure that as the laboratory you have documented all your communication with the supplier as well as thinking about alternate risk mitigation can you implement -such as contingency or alternate suppliers. If you have done that auditors will be satisfied that you have done everything in your power to minimize the risk.
Hi everyone. I am totally agree with Nicoline. In some cases, the treatment for NCE and ensure efectiveness of the corrective action in order to prevent its reoccurrence is a challenge. I consider that in the cases when the NCE needs to be treated with RCA and implement corrective actions, the key is to find and analyze the root cause, because if we do identify and analyze the principal root cause, the implementation of corrective action would be effectived and we would ensure the non conformity would never reoccurrance again.
On the other hand, I would like to ask if you can help with this NCE. It is a real case. If our laboratory is auditing with the ISO 15189 (audit criteria) and the audit finding is related to lack of biosafety practices in the laboratory, if it is neccesary to state the NC, what would be the non compliance requirement for this NC according to the ISO 15189? In our case, we consider that the possible non compliance requirement could be 5.2 Accommodation and environmental conditions, because the standars states that the laboratory shall have space allocated for the performance of its work that is designed to ensure the quality, safety and efficacy of the service provided to the users and the health and safety of laboratory personnel, patients and visitors, or it could be 5.2.6 Facility maintance and environmental conditions, due to the standard states that Laboratory premises shall be maintained in a functional and reliable condition. Work areas shall be clean and well maintained, and so on. Are you agree or there could be another more accurate ISO 15189 requirement.
Thanks so much for your attention.