(ISO) Quality Manual Chat

Your ISO9001:2000 quality management system requires you to gather certain kinds of data, and periodically analyze this data to see how you’re doing. ISO9001:2000 is all about “continuous improvement”, after all. In order to show that you’re continually improving, you have to be able to measure certain objective parameters.

You must be able to show, through your data, that your quality management system is effective, and you also must be able to evaluate where improvements can be made. Data used for these purposes can be gathered from within your organization, and also from external sources. Every company is, of course, different, and the data you gather will be unique to your situation.

ISO does give some specific guidelines about what kind of data you must gather.

First of all, you have to gather information that allows you to objectively measure customer satisfaction. How you do this is up to you. Some people use customer surveys. You might have your outside salespeople fill out a report every time they visit a customer. You can have your inside sales or customer service people keep a log of customer comments, both good and bad. Keep in mind that you have to come up with some kind of objective measurement, so however you do it, it’ll be easier to deal with if you can turn your data into numbers.

You have to gather data that shows conformity to product requirements. This might take the form of inspection records, testing reports, rejection reports, etc. Nonconforming material reports might be used to keep track of how many rejections occur. Maybe you will compare the number of rejections versus the number of parts that pass, and come up with a percentage. Maybe one of your quality objectives is to have 99.9 percent of products pass inspection, and you currently have 99.2 percent. Now you have a concrete objective to work towards. Hopefully you can come up with ways to improve your product and/or processes so that over the next year you’ll reach 99.3 percent of products that pass inspection. It’s not much, but its improvement, and this is what your ISO auditor will be looking for. Quality objectives should be, in my opinion, slightly out of reach. You always want to be able to show improvement, but the moment you actually hit your goals, well now you’ve got to set your goals higher!

ISO9001:2000 requires you to gather data that show characteristics and trends of your processes and products, including opportunities for preventive action. This requirement has always seemed a little vague to me, and I’ve never heard a great way to accomplish this. Fortunately most auditors I’ve worked with apparently also think it’s vague, as I’ve never had to deal with this during an audit. As long as you have documented a system that includes preventive action, and you keep track of trends in your processes, you should be fine.

The last bit of data that ISO requires you to monitor is your suppliers. You must maintain records on your suppliers, showing their performance. Again, how you do this is up to you. Keep records of each supplier, and go thru and approve them at least once per year to show that you monitor their performance. If possible, keep track of your suppliers’ delivery and quality performance.

Work instructions are an optional part of an ISO9001:2000 quality management system. No, you don’t need them, they’re not required. Yes, they are often a good idea, and there’s a really good chance that you should have them.

If your people have lots of processes that would benefit from having documented instructions, and these instructions affect the quality of your product or service, then voila! you need work instructions.

Work instructions are another tier of your quality system documentation. So what are the requirements for constructing your work instructions?

Actually, there are no requirements for how you construct your work instructions.

There are various items that you might want to include in your work instructions, and these are similar to what you’d write an ISO procedure. Some of the items you might include in work instructions are: 1) purpose, 2) scope, 3) responsibilities, 4) definitions, 5) work instruction steps, 6) safety & environmental information, 7) associated documents, 8) document revision history.

But don’t feel compelled to include all of the above in your work instructions. In its essence, a work instruction pertains to a signle activity within a larger process. Keep your work instructions concise, to the point. You want to describe the who and the what and in which sequence things happen. Its a good idea to first write down all the necessary steps in carrying out that activity and then break it up into individual tasks. You’ll probably find it easiest to format your work instructions in a manner similar to your ISO procedures.

Keep in mind, though, that you don’t need to write your work instructions so detailed that a moron could follow them. It is reasonable to assume that the people who use the instructions have a fair degree of intelligence and experience, and your work instructions are written for them. So don’t go nuts.

Also keep in mind that work instructions can take many forms. A picture on a wall, a flow chart, a cartoon, a video, a set of example parts glued to a piece of wood, these are all forms of work instructions.

Ultimately you have to ask yourself “Can the worker do the job correctly, based on the work instruction?” If you can’t honestly say “yes”, then try, try again.