Design, application and validation of corrective measures after an audit or inspection
The corrective measures to be applied and implemented after an audit or an inspection: an important technique to understand well and adopt
The design, application and validation of corrective measures after an audit is an important step for the return to compliance on the one hand and also to continue the efforts towards continuous improvement.
Before talking about Design :
It is important to start with a post-mortem following an audit or an inspection in order to clearly identify the non-compliances to be resolved. It is strongly recommended that you subsequently 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.
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 and eventually into preventive measures too!
Design of corrective measures
The results of the gap analysis allow you to identify what will be done with the corrective actions allowing you to meet compliance requirements again.
It is therefore a matter of defining the who, what, when, why, 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 or abide to
-
any other internal or external requirements or policies and/or standards that you must comply with
The global view here is very important to make sure 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 often happens)
-
enforcement issues related to
-
the distribution of responsibilities in the team
-
costs not considered
-
lack of staff
-
unsuitable or unavailable equipment/material
-
-
omissions in:
-
cross Referencing and updating
-
updating signature registers
-
-
disagreements between the production team, the quality team and/or the maintenance team on the addition/changes of additional measures corresponding to additional responsibilities
How to proceed
How to validate and implement your corrective measures:
-
gradually
-
by asking a non-involved person (s) to assess the effectiveness of the corrective action
-
documenting everything
-
by not hesitating to make the necessary corrections as it goes
-
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 developing, implementing or improving your strategy for the design, application and validation of corrective measures after an audit or inspection. This will allow you to greatly limit the risk of recurrence. This will help improve your level of regulatory compliance, compliance with customer requirements or applicable standards. This will minimize the repetition of non-compliances that can make difficult your relationship with the regulatory authority, audit firms and clients. This will also strengthen your approach, give it more rigor as well as save you time and money.