Must a registrar employ a certified lead auditor?

Step Six: Audit and Manage to Initiate Corrective Actions and Prove System Integrity

Initiate corrective actions and prove system integrity

Celebrate the launch of your management system to recognize and thank the Task Force and everyone else for their tenacity in making it happen. Remind everyone that the system is there to be used and improved. Ignoring the system is not an option for anyone – including the managers.

Knowing when your system is "complete" and ready to launch is very indistinct when you consider the following facts:

  • System documents largely reflect existing practice
  • Many forms were already issued and approved for use
  • Other system documents were issued for use as they were approved
  • A system is never "complete" because it is continually improved.

The last procedure to be issued for the first time could coincide with the first procedure being revised and reissued for the third time. All of this is possible because of the robust document coding procedure (see Action 8).

One positive way to mark this event is with the first internal audit.

Early audits tend to be focused on conformity and this is understandable. This should not be needed with the as-is procedures but it will happen! Then you will discover how well done were the analyses, reviews and reconciliation of all review comments. It is not unusual to find after months of stressing the as-is rule, for example, that only a few folks were listening!

Move internal auditing up to obtaining evidence of effectiveness as quickly as you can. If your procedures have measurable process objectives and your auditors have been well trained you should achieve this without too much trouble.

When the search for evidence is relentless then you’ll be ready to focus on some of the more important key processes for improvement such as taking corrective actions and reviewing the performance of the system. Do not forget to audit the effectiveness of the internal auditing itself!

Often audit becomes the driver of all improvements. This is a bad sign. Well-understood and welcomed systems find that only 20% of the corrective and preventive actions are initiated by audit.

The 80%+ should come from team members in their daily work. Measure this key statistic and use it to improve acceptance and use of the system. You will have convinced team members of the value of documenting key processes so also formalize the process for employees to impart their wisdom to drive the majority of the improvements.

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