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Resolution of non-compliances

Effectiveness, resolution of CARs and non-compliances

All industrial laboratories industry participants agree that this is not the most "glamorous" or enjoyable part of the job. On the other hand, this work must be done and well done .

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The more efficient you will be in resolving non-conformities :

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  • More operations will be your fluids

  • The less risk you will have of major non-conformities

  • The more pleasant your relationships with the regulatory authority, audit firms and clients are

  • The more you will save time and money by putting your efforts in continuous improvement instead of solving problems

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The resolution of non-conformities concerns all staff and not just the quality team. It is by avoiding looking for culprits and adopting a team - based approach that you will increase your efficiency .

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There are many problem-solving methods available , but once again the best method will be the one that suits each case and the one that is easiest .

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Problem solving methods

The main important points to consider when choosing a problem solving approach / method are:

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  • Focus on identifying the root causes - " Root causes " - as a first step

  • Use documents , work procedures and instructions , results of monitoring , analysis , etc. that you have in hand and which are your working tools

  • Do n't look for culprits

  • Work as a team

  • Carry out and document an investigation gathering tangible evidence and testimonies

  • Involve production staff

  • Do not hesitate to contact representatives of the regulatory authority or audit firms to fully understand the non-compliance

  • Do not hesitate to seek help from an external resource such as suppliers , consultants , applied research institutions , etc.

  • Do a post-mortem as soon as possible after receiving the non-compliance

  • To ensure that there is only one person in charge in order to avoid confusion and cacophony

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Among the main methods that can be used to solve problems related to non-conformities are:

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  • Cause and effect diagrams

  • Les 5W2H : Who, What, When, Where, Why, How and How much

  • FMEA

  • Root Cause Analysis and Identification

  • Brainstorming

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Méthodes

Resolve a non-compliance

To address non-compliance effectively and prevent recurrence , it is essential to have a procedure that explains your approach and how you use. Documenting this in a procedure allows you to be prepared and avoid shooting all over the place when a non-compliance is issued against your business .

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You will thus avoid panic , you will be able to gather valuable information by carrying out a post-mortem quickly and by exchanging with the people who were directly involved, etc. Your most valuable assets are problem-solving methods . Remember that you have the freedom to apply the methods that seem most relevant to you in each case .

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We are able to help you develop, implement or even improve your strategy , your procedure or your methods for resolving non-conformities so that you are able to minimize and prevent recurrence as well as comply with the requirements of regulatory and normative compliance and those of your customers (including those stipulated in the GFSI standards). This will allow you to react quickly and demonstrate that you are able to resolve non-conformities quickly and efficiently while allowing a rapid return to normal for your operations .

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