I work for a small company as a Quality Manager. I basically am a one man show (really I am a woman :tg: ) We are ISO 9001:2000 certified.

Anyway, people here think it is the Quality Managers job to not only do all internal audits but also do all CA's generated from the internal audits and follow ups from the audits too.

I had one manager give me a one word root cause and a three word corrective action plan on our CPA report. :mad: And this finding was from our registrar peridoic audit.

They feel because I am a full time quality person I should do everything. HELP!!!

At my company where I am the Internal Auditor, Supplier Quality contact, Warranty Investigator, Calibration Administrator, gopher, git 'er dun guy, I don't have the time to answer the CAR's that I write. And if I did, it would be a waste of time. Corrective actions will only correct problems if the process owners have a hand in fixing them. I assign the CAR to the supervisor of the problem area, and inform the areas manager at the same time (via email). If the recipient needs help answering I will talk them through it and help them come to an adequate root cause and CA. I dislike answering for them as they usually know a better way to fix something and just didn't know how to push the fix through the system. Also If I answer, they won't care about really fixing anything.

When they do answer, I will not accept one word root causes, and then I will come to their aid until they come up with an acceptable answer. This actually takes a great deal of my time that I wish I didn't have to spend holding the hands of recipients, but I have noticed that I only have to do that once or twice.

I hope that helps. :cfingers:

The Standard states:

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes
Personally, I believe it would be better if the Standard said "The management responsible for the PROCESS being audited..."

I feel your pain! However, I have to ask what the content of the internal (or external) audit findings actually is? I'd suggest that in many cases, any manager would react unfavorably to audit findings (and therefore corrective actions) if it doesn't give them some relief from a business performance issue - such as late delivery, scrap, rework, etc. Perhaps you could share some insight into the type of findings?
Andy

As Sidney says, it is the process owner who is supposed to take the corrctive action. And unless the process owner "owns" the action, it will not be effective. your MAnagement Reviews can be a great help in this aspect. Convince your management to specifically asign responsibility and deadline for each CA discussed to the process owner and record it in the minutes for review in the next meeting. Your help will always be available to whoever wants it.

Why process owner? Because in an organisation, the processes are very much entangled. Its like running a three legged race. Any CA required in any area may not fall under the responsibilty, more importantly the authority of the person incharge. For example - an obsolete document being found with a user, an out of calibration instrument lying around, ...

In such cases the MR is expected to redirect the CA to the person responsible for the process. It should be seen that the CA is effective.

Going by the definition of CA, you ensure that a "problem that has occured once does not recur". So long as this is done effectively and verified for effectiveness, the procedure is followed while doing it, how many words are used to fill the form is not really relevant.

Sounds to me like the old-world "Quality will fix it" mindset.

But if you didn't design these processes, as others have said they are not yours to fix.

I have started categorizing my corrective actions by criticality based on risk. If the problem is small, like a need to update a document--but it doesn't present a risk to product or represent a change in how the process is bring done, I have been leaning toward filling out the response tracking of CAs myself. Not everyone would agree, but my position is that I'd like to tone down the "noise" so the CAs I hand over to others are clearly needing their expertise and involvement. The documents' owners still have to make the changes of course, but I review them before "publishing" and I have also given pointed instruction since I know that not everyone understands the requirements like I do.

This is a slippery slope (filling out tracking forms myself) of course. It's unfortunately hard to give much better advice than this since I don't have a close up view of your processes and people.

Bottom line is, QA is a support function and not the repair shop of the QMS. You can show them, facilitate, develop tools to make fixes effective but you're not the process owner. Point to the Responsibility and Authority clause.

Sounds to me like the old-world "Quality will fix it" mindset.

Bottom line is, QA is a support function and not the repair shop of the QMS. You can show them, facilitate, develop tools to make fixes effective but you're not the process owner. Point to the Responsibility and Authority clause.

AGREED!

Had similiar issues in the past and handled it by an evolving "train-the-auditees" approach. Some things I introduced in my approach to internal audits were;

1. Showed a power point presentation to auditees on an overall view of an internal audit process, from start to finish. Listed what the responsibilities where of the auditor and the auditees.
2. Provided templates of reports or CA plans to assist auditees in their responses.
3. Always got buy in if a process owner was given an action item.
4. Generated a monthly update of the internal audit process with status of audit and process owner. Which was sent to Senior Managment and the auditees.

For me, it was the frustration that got me. From either people saying "Oh, I'm supposed to that?" to just being ignored when there reports were diliquent.

HTH

The management of the process is issued the corrective action. That is what I do as I issue the CARs here.

The management of the process is issued the corrective action. That is what I do as I issue the CARs here. This is normally right and should be the normal state of affairs, but there are sometimes mixed authorities and responsibilities aren't always sensibly assigned.

Sometimes the CAR can be assigned to someone besides the process owner, but this should be done with care and consultations to make sure everyone is good with it.

This is a pretty common situation.

I feel that some of the responses nibble around the edges. I think eerhine is closest to my idea of the most efficient way to deal with the issueWhen they do answer, I will not accept one word root causes, and then I will come to their aid until they come up with an acceptable answer. This actually takes a great deal of my time that I wish I didn't have to spend holding the hands of recipients, but I have noticed that I only have to do that once or twice.

I've always seen the function of a Quality Manager as that of TEACHER, not "grunt who does all the work." If I issue a C/A, it is only AFTER a sincere talk with the process owner which establishes:

the process owner agrees with the nonconformance as true
the process owner understands the difference between "correction" and "corrective action"
the process owner has a good understanding of the "root cause" investigation process
the process owner understands a "workable format" for preparing a corrective action report (sometimes organizations are so used to having nonconforming processes they have preprinted forms - that is not an organization that has a good idea of making permanent corrective actions:bonk: )
the process owner agrees on a date for a full response or a progress report (setting a new"closeout date")