ICORP GROUP · INSIGHTS

GMP / FDA / HACCP / HALAL / ISO: Prepare Systems and Evidence Before the Audit Rush

The common risk in the preparation of Audit is accelerating the documentary delivery at the end. More importantly, the system, the documentary and the operation must be truly consistent.

Starting with the interpretation of the requirements to meet the corporate context.

Each type of standard has different focus points. The organization should then start with an understanding of the scope that is self-related, then convert the requirements into responsibility, processes and evidence that the team can apply.

Review what exists before creating a new document.

Gap Assessment should be done to see what policy, practice, form and original evidence are used. What parts are adjusted and which parts are real. This reduces the creation of repeated documents.

Check whether the actual operation is in line with the document?

Beautiful but not real-use documents do not help to increase availability. Workflow should be reviewed with the operator and check whether real evidence can continually reflect the process.

Manage owners of processes and tracking systems.

Each issue should have a clear responsible and an action plan for the issues that are not prepared. The administrator should see the issues that need resources or cross-organ decision.

Don't wait close to Audit, so you start testing the system.

Internal review or simulation of situations allows the team to see points that are also interpreted inappropriately and have time to resolve before a real assessment day.

ICORP has the range of quality and standard system consultants such as GMP, FDA, HACCP, HALAL, ISO and Healthcare standards. It can help to set Gap Assessment, Roadmap, Workshop and track results in a corporate context.