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Design, application and validation of corrective measures after an audit or inspection

Corrective measures to be applied and implemented after an audit or inspection: an important technique to master

The design, application and validation of corrective measures after an audit is an important step for the return to compliance as well as to continue/maintain the level of the efforts on continuous improvement .

Before talking about Design :

It is important to start with a post-mortem following an audit to clearly identify the non-compliances to be resolved. It is strongly recommended to carry out a gap analysis which will make it possible to clearly and objectively define the work to be carried out to regain compliance and even improve and eventually avoid recurence.

Once the gap analysis has been carried out, the objectives and/or the steps to be taken to regain compliance will be clear and easy to transform into corrective measures .

Design of corrective measures

The results of the gap analysis allow you to identify what should be included in the corrective actions that will allow you to meet compliance requirements again.

It is therefore a matter of defining the who, what, when, where, how, documents , etc. to properly formulate the corrective measures to be taken. It's like a work plan with deliverables. It is important to take into account all the requirements applicable to your establishment or organization such as:

  • Regulatory compliance requirements (food, health and safety, environment, etc.)

  • Customer requirements

  • The norms and standards that you must respect/comply with

  • Any other internal or external requirements or policies and/or standards that you must adhere to

So the overall picture is very important to ensure that the measures taken will include and will fulfill all the requirements that apply to you.

Validation or testing

Although some corrective measures seem obvious and do not have to be validated or tested; it is recommended to do this in order to avoid:

  • To underestimate the ramifications of your documentary system (and it happens often)

  • Implementation problems related to

    • The distribution of responsibilities in the team

    • Costs not identified or not considered

    • Lack of staff

    • Equipment / material not adequate or not available

  • Oversights in:

    • Referencing and updating

    • Updating signature registries

  • Disagreements between the production team , the quality team and / or the maintenance team on the addition of additional measures corresponding to additional responsibilities

How to proceed

How to do the validation and implementation of your corrective actions:

  • gradually

  • by asking a non-involved person to assess the effectiveness of the corrective measure

  • by documenting everything

  • by not hesitating to make the necessary corrections on an ongoing basis

  • by applying the worst-case scenario conditions in order to guard against recurrence as much as possible

We are able to help you support you in order to implement or improve your strategy concerning the design, application and validation of corrective measures after an audit . This will allow you to greatly limit the risk of recurrence. It will also help to improve your level of regulatory compliance, compliance with standards as well as your customers ' requirements while minimizing the recurrence of non-compliances that can make your relationship with the regulatory authority and customers somewhat difficult. This will also strengthen your approach and give it more rigor and strength.

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