Hello Quality Pros, need your input:

What could be some corrective action objectives that could be tracked to monitor 8.5.2 corrective action? Since corrective action is a process it follows that objectives to track its effectiveness would be needed, can you provide a few samples that are used out there in the field?

With regards to the closing time of some of my company’s CARs, we have found that for our overseas suppliers it is hard to impose a time limit to our suppliers to respond to a CAR issued due to the suppliers’ distance, language and in some cases their QMS are not aligned to ISO. My objective as an MR is mainly to address the complaint, issue a CAR if needed and close the CAR, I am not concerned with the time to close the CAR due to the above explained. Also, some of our internal CARs sometimes it takes some time due to constraints and thus imposing time limits on our employees to reply hinders production. What is your opinion? let me know. We are being real with the way our QMS and relations with suppliers are conducted and thus I don’t want to state time limits or other unnecessary objectives.

Thanks,

In regards to the Internal Corrective Action, it shouldn't even be an issue. I don't buy the excuse of time constraints or slowing production. The Corrective Action is exactly what it is "Fix it."

If your response times (internal) reflect a continuous problem then consider allowing for an extension and investigate the Root Cause. There might be something else that is causing these issues.

Measurables

Response time
Repetitive problems
The number of

These are just a few of the measurable in my opinion.

I agree with you that time to close and number of CAs are in many cases completely inappropriate and meaningless.

What are you actually trying to achieve with CA? My guess is: effective action to resolve, and no recurrence? So be looking for objectives around these.

1. Whether the action taken was effective in fixing the problem(s)?
2. Whether the same (or similar) issue recurred - in which case go & query #1 again.

Depending on where you are in the maturity cycle, you might also look at some other objectives - eg, are you trying to get lots of personnel knowledgeable about how to do this? Do you want them to get better at doing it? etc.

Corrective action objectives:

1. number of valid CA against number of issued NCs (some of the CAs being returned to the auditors are not valid, i.e., they do not address the root cause, they do not prevent recurrence, etc. etc.) - this is a measure on the effectiveness of the RCA

2. number of follow-up audits that are performed on the appointed time

3. $$$ spent on corrective actions versus $$$ budget of the department

4. $$$ spent on corrective actions versus $$$ savings on improved processes

Okay, maybe I'm simply becoming hung up on terminology, but aren't objectives and measurables two different items?

I read 'measureables' to equate with (key) performance indicators. Several Cove members have provided examples of possible (key) performance indicators, as well, such as "% of..." and "# of ...".

Objectives, to me, would be "A xx % reduction of yyy by zzz" or "A 25% reduction of recurring nonconformances by December 31, 2009."

However, we would need some historical data - aka (key) performance indicators - so that we could set a proper objective.

This leads me to ask a question....

Juliov, is your organization establishing an objective for every clause of the standard?

Hello Quality Pros, need your input:

What could be some corrective action objectives that could be tracked to monitor 8.5.2 corrective action? Since corrective action is a process it follows that objectives to track its effectiveness would be needed, can you provide a few samples that are used out there in the field?

With regards to the closing time of some of my company’s CARs, ... We are being real with the way our QMS and relations with suppliers are conducted and thus I don’t want to state time limits or other unnecessary objectives.

Thanks,

One of the metrics we have where I work is # of nonconformances as a % of assemblies shipped. We also Pareto our nonconformances to find the top re-occuring ones and take corrective action on those. So as far as assessing our corrective action effectiveness I go back to our nonconformance %. If our % is trending down over time, I state that as evidence of effective corrective action.

As far as tracking the amount of time it takes to close CARs, I agree with Jane's comments and have found no value in doing that at all. I will put an estimated due date on our CARs but only use it for tracking purposes and as a reminder to follow-up with someone if I haven't had a response for a while.

Total # as a % of Sales Orders
Elapsed time to Close
Total $

You can also break it down by Dept/Cause for Continuous Improvement Objectives.:(

RC,
No, we are not implementing objectives for every clause of the standard, what processes then does the standard recommend to implement objectives? sometimes the standard is not explicit in defining where objectives are needed. Clause 8.2.3 of the ISO std is a bit implicit about objectives. Comments?

No, we are not implementing objectives for every clause of the standard,

Phew...where's that "breathe a sigh of relief" emoticon when I need it? :rolleyes:

what processes then does the standard recommend to implement objectives? sometimes the standard is not explicit in defining where objectives are needed. Clause 8.2.3 of the ISO std is a bit implicit about objectives. Comments?

ISO 9001:2000 does not state what objectives an organization is required to have. Clause 5.4.1 "Quality objectives" simply states that top management needs to estalblish quality objectives and that they be measureable, etc.

Clause 8.2.3 "Monitoring and measuring of processes" is about ensuring there are means (such as metrics and indicators) to demonstrate that you have controlled processes (i.e., that the processes are resulting in products that meet specifications).

When expected process results are not achieved, typically product does not meet specifications, and that's where the link is to corrective action. If an out-of-control process resulted in nonconforming spec, your root cause and action plan should focus on the process.

All of the examples that have been provided by Cove members in this thread are types of metrics that your organization could track as a means to determine if you have control of your corrective action process.

However, I do recommend that your organization:

Not track these numbers for the sake of having numbers
Not estalish goals or acceptable control limitsplan on not
Not ignore situations when goals are not attained or results are outside of the control limits
Understand what the metrics mean and how they demonstrate the effectiveness of your organization's corrective action system


To simply record numbers for the sake of having numbers and to not understand what the metric really means, will frustrate people and the organization's faces the possibility that employees will lose faith in the system.

ISO 9001:200 does not tell us how to do meet the requirements...only what we need to do.