Archive for January, 2008

Preventive Action Request- Ambiguous? Ever done one?

Saturday, January 26th, 2008

The ISO9001:2000 quality standard is undergoing revision at this time, and it looks like the new version will be called ISO9001:2008. And, no surprise, it’s expected in late 2008.

The ISO9001:2008 standard is expected to contain no significant changes from the 2001 standard. Instead, it will merely attempt to clarify some areas of the 2001 standard that some thought were ambiguous.

One aspect of ISO9001:2000 that many people consider ambiguous, and many (like myself) consider to be unrealistic, is that of “preventive actions”.

I’ve heard it described that preventive actions are the proactive cousin to corrective actions, and I kinda like that description. Preventive actions are, of course, actions taken to prevent something bad from happening. And corrective actions are actions taken to correct something bad that has already happened. Any good corrective action, of course, will also contain a preventive action to make sure that whatever bad thing that happened does not happen again.

But what about the preventive action standing on its own? In about 14 years of quality system management experience, I have not once seen anyone make a formal preventive action request. Oh, sure, we have a procedure for that, and a form too. Well, actually its the same form as used for Corrective Action Requests, just with a checkbox used to distinguish Preventive from Corrective actions. But the form and the procedure are there, right? So how come no one ever writes these up?

I’m guessing that preventive action requests are done more frequently in large companies that have dedicated quality people searching for things to do. Quality people in small, entreprenurial companies probably wear several hats, and are usually way too busy operating the company to create more work for themselves by writing up and dealing with “preventive actions”. Just fix the damn problem, don’t talk about it!

It just dawned on me that female quality management professionals probably write up far more preventive action requests (and corrective actions) than do their male counterparts. Guys, after all, just want to fix problems NOW! Our testosterone-challenged colleagues, though, often are more interested in TALKING about problems than in actually resolving them.

Hmmmm….this could be a whole new slant on quality system management. How do men handle quality issues versus women?

Posted in General quality system | 6 Comments »

ISO9001:2000 section 5.5 Responsibility, Authority, Communication

Sunday, January 6th, 2008

According to section 5.5 of the ISO9001:2000 standard, to be in compliance with the ISO standard you must ensure that responsibilities are well defined. documented, and communicated throughout your organization.

One task you must do is appoint a management representative to the quality system, which we’ve discussed recently in another post.

Today we’ll go into the “internal communication” part of the requirements.

Your company’s top management must ensure that there are established and documented methods of communication within your company, and that communication actually takes place regarding the effectiveness of your quality system. Of course, in order to prove to an auditor that communication actually takes place, you must have records. Sorry, it’s not enough for you to simply tell your auditor something like “yeah, sure, we talk about the effectiveness of the quality system all the time!”.

As with most things relating to ISO9001:2000, the standard tells you what you must do, but leaves it up to you how you should accomplish the task. As long as your methods are effective for your particular situation, and they pass the scrutiny of an ISO auditor, you’re good to go.

One highly effective method of internal communication regarding the effectiveness of the quality system is the management review meeting. Periodic management review is another requirement of ISO9001:2000, so in a way you’re killing two birds with one stone by conducting management review meetings. Of course you’re recording your management review meetings, their input and output, etc, so this is one way to prove to your auditor that you have a method of communication and you’re actually communicating. The minimum frequency for management review meetings is once per year, but I highly recommend having them more frequently while your new quality management system matures. If you’re actively using your new quality management system, you’ll likely have to make quite a few changes in the first couple of years.

The management review process should not be the only method of internal communication used regarding the effectiveness of the quality management system. You can use things like memos, signs, other scheduled and non-scheduled meetings, training programs, and whatever other kinds of communication you can think of. Just be sure your methods of communication are well documented in your quality manual and/or procedures, and that there are records of these communications taking place.

Posted in General quality system, ISO9001:2000 blog | 1 Comment »