If nonconformities are determined to be systemic (i.e., the nonconformity has been realized AND it’s expected to occur again if not resolved), you have to take actions to both correct the issue AND prevent its recurrence.

Thus, any CA has a PA component.

This goes back to the definitions of corrections, corrective actions, and preventive actions discussed earlier. All such actions need to be defined, implemented, and assessed for effectiveness.

For each action taken, you should

1. Document

Document the actions required (refer back to the “document everything” tenet)

2. Define

Define completion criteria – how do you know when the action is complete? If you assign an action to improve a process or a product (feature), how would you know if it’s complete? On the other hand, if your action is to eliminate shipping errors (incomplete or incorrect shipments), you can measure that!

3. Verification

Define how verification of the action is determined. Using the shipping errors example, you can check with individual customers to determine if their shipment was complete and correct.

4. Effectiveness

Determine how effectiveness is to be determined. We can continue with the shipping example: maybe it’s acceptable to have 10% failures in shipping – so, over time, you can determine if 90% of orders are properly fulfilled. Maybe it’s 99% – that’s where you have to make the determination. Of course, this needs to be risk-based. If patient or user safety is in play, maybe 99% is not even sufficient.

5. Assign

Assign an individual owner, not a group of owners. Ensure some ONE is responsible (he or she may need to rely on others but without individual ownership, the results could end up being finger-pointing.

6. Completion Date

Work with the owner to determine a reasonable completion date. Arbitrarily assigning completion dates is a recipe for failure. Get concurrence with the owner that the completion criteria is understood and achievable.

7. Available Resources

Support the owner by ensuring the resources are available. If results require the inputs from a particular Subject Matter Expert, if that individual is not available, the action probably cannot be completed as expected.

8. Frequent Meetings

Don’t assume things are getting done. Have frequent status meetings to monitor progress. Based on the risk, frequency may need to be daily!