Corrective Action Reports

Why do we do the follow-up of a corrective action? 

Because we want to verify two important things:

• Was the corrective action implemented?
• Was the corrective action effective? 

When I work with organizations, I never recommend a universal rule for the time to perform the follow-up. Some corrective actions will be fast to implement and get results to check effectiveness, but others will take more time. What I recommend is that after determining the root-cause(s), the person responsible to propose the corrective action also proposes two important commitments:

• The target result; and
• The time needed to get that result. 

That way, when a corrective action proposal is approved it is also clear what will be the test to declare effectiveness, and when will it be done.

The following material will provide you more information about corrective actions:

- How to proceed once a QMS corrective action is defined? - https://advisera.com/9001academy/blog/2016/09/20/how-to-proceed-once-qms-corrective-action-is-defined/
- Free webinar – Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Corrective action reports must be answered 5 days after it was issued to someone right? Does that mean I also need to follow up him/her after 5 days? Thanks

There is nothing in ISO 9001:2015 stating that corrective action reports must be answered in 5 days. However, if your quality management system internal rules determine that, then 5 days is the rule to follow. So, people have to answer in 5 days identifying the cause(s) and proposing a corrective action to implement. And you can check, after 5 days, if an answer was given. But follow-up does not end there. 

• Was the corrective action implemented?
• Was the implemented corrective action effective?

These two questions most of the time can take more than 5 days.

For example, an organization during management review concluded that the rate of complaints was too high and should be reduced. 

A corrective action was requested.

After data analysis the main reason for complaints was confirmed: delivery delays.

After investigation the main cause was determined: lack of production capacity.

As a corrective action it was proposed that within 30 days a third shift would start production.

One can check after 5 days if an answer was given.

One can check 30 days after the answer if the third shift is already in operation. Let us suppose so. Now comes the question: is the third shift introduction effective in reducing the number of complaints?

You can determine that after 90 days of a third shift in operation you will check effectiveness. And after 90 days you compare complaints rate before and after and you realize that complaints due to delivery delays completely disappeared. Effectiveness was confirmed. Now the corrective action request can be closed.

Set for example I issued a Corrective Action Report to a certain problem which has 30 days of target completion date for corrective action. But the same problem occurs the other day, do I have to issue another corrective action report? Or i'll just make the first corrective action report as a reference for the second occurence?

Thank you for your response. It was very helpful

When an organization detects a non-conformity, it must correct it and record both the occurrence and the actions and decisions taken. See clause 8.7.2 of ISO 9001: 2015. 

The fact that a non-conformity occurs does not require the mandatory triggering of corrective action.

Corrective action often represents too high an investment for some non-conformities that occur. Real corrective action involves investigation and testing of theories, something that costs time and money.

What I propose to organizations is that once the non-conformity is eliminated the question arises: Does it make sense to take corrective action? Does the frequency of non-conformity, and its cost or severity, advise investing in corrective action? If so, progress to corrective action. If not, the treatment of non-compliance ends there. Note that ISO 9001: 2015 states that organizations should take appropriate action based on the type of non-conformity and its impact on the conformity of products and or services.

In the case that you report:

• A non-conformity occurred and was addressed; 
• It was decided to take corrective action; 
• During the implementation of the corrective action a new non-conformity occurred; 
• A new non-conformity record has to be opened and when asked if it makes sense to open corrective action, refer to the number of the corrective action in progress and close the record; 
• Remember treating a non-conformity it is not the same thing as developing a corrective action.

Please check slide 16 of this free webinar on demand - Free webinar – Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/

So giving corrective action is not required to all occuring nonconformities? 

If I have a nonconformity and corrective action is taken but the same nonconformity occurs the next day, Do I have just to copy the corrective action from the first one? 

Thank you very much. 

I must admit that your previous message made me suspect of that. 

Yes, not all occurring non-conformities require a corrective action.

Yes, all occurring non-conformities need to be recorded. If your quality management system internal rules required that non-conformities be recorded on a corrective action request, you have to do it and copy the corrective action from the first one. 

Consider the possibility of simplifying your quality management system internal rules by separating recording of non-conformities from recording of corrective actions. Please consider this article - ISO 9001 – Difference between correction and corrective action - https://advisera.com/9001academy/blog/2016/02/09/iso-9001-difference-between-correction-and-corrective-action/