Managing non-conformance roles in

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In this tutorial, we’re going to look at how to set the roles in, ready for sending non-conformances.

Before we do though, let’s just explain how works. When a non-conformance is created, will use the information that you provide, to send the non-conformance to the correct person. This means, that you don’t have to manually send each non-conformance – the system is automated to save you time.

So that knows who the correct person is for each non-conformance we must set up some rules. There are two key roles when managing non-conformances – the accountable manager and the verifier.

The accountable manager is accountable for a particular topic and the verifier will check any corrective and preventive actions have been satisfactorily completed from that topic.

In there are 18 topics, which are:

  1. Senior management commitment
  2. Document management
  3. Continuous improvement
  4. Contingency planning
  5. Product Safety Plan
  6. Contamination control
  7. Product development
  8. Supplier management
  9. Testing
  10. Maintenance
  11. Product defence
  12. Training
  13. Personnel
  14. Site standards
  15. Risk-based facilities
  16. Hygiene
  17. Process control
  18. Intake, storage and distribution

When a non-conformance is created, it must be assigned to one of these topics. If you’re on plan 2, 3 or 4 this will be done automatically by from GMP inspections and system audits.

However, when creating a manual non-conformance, the topic that it relates to must be selected. This means that before you can send any non-conformances you must set up the accountable manager and the verifier for each topic.

To do that go to settings. Here you’ll see the list of the topics. If you don’t have high-risk, high-care or ambient high-care facilities then you can ignore topic 15 risk-based facilities. If you’re an agent or a broker, then 10 maintenance and 14 site standards won’t apply to you either.

To set up the topics that are applicable to you, just press edit.

To select the accountable manager and the verifier, just use drop-down lists provided and click save.
Please note, this pop-up box will show you the roles that are relevant to the plan that you’re on.

So, if you are on plan 2, 3 or 4 you’ll have more options. We’re just focusing on the roles that are needed for non-conformances now.

You can learn about the other roles for GMP inspections and system audits in the relevant tutorials, which are linked below.

If the users you want aren’t shown in the list, then you’ll need to set them up first in the user’s area.

Couple of important points:

  1. You can’t have the same user as the accountable manager and the verifier. This is because you’re not allowed to check your own work.
  2. If you have a small team, you can have the same person doing lots or all the roles for accountable manager and then another person doing all the verifier roles.

Please be aware though, is trying to encourage you to drive cultural improvement. A business with a good culture will ensure that accountability is placed in the right area.

This means that the most senior person should be accountable for senior management commitment. It also means that the person who runs the warehouse for example, should be accountable for intake, storage and distribution. If they’re accountable for these areas, then the non-conformances from these topics, should go to them.

You just need to repeat the process until you’ve got all your accountable managers and verifiers set up. And if in the future, you want to amend a role, you can just come back and click edit, make your changes and then save.