Experience ISO Excellence

Rob Kantner answers your questions:


Process Validation: What's involved? (9/15/08)

RE: ISO 9001 7.5.2 Welding and Painting Processes. . .Do you think that a statement such as "Samples will be supplied if requested along with only properly trained and qualified welders and painters are employed"? would be sufficient to address the process validation requirement?

The language you suggest above is very general policy language. There's more to process validation than this. At minimum you should: a) document the process steps in sufficient detail to assure that they will be carried out without significant variation; b) ensure that operators have appropriate and documented qualifications, skills, and training; c) carry out trial / test runs to assure that the resulting product fully meets customer requirements.

If the part(s) you're making are critical to product form, fit, function, and (especially) safety, you may also want to do product tests of a random sample of units from time to time, and establish full part traceability with appropriate records.

FMEA: How far upstream? (6/4/08)

Ours is a forging industry. We have made FMEA for all operations in forging process. Forging is Tool dominant process. My question is - Do we have to make FMEA for Die manufacturing process?

From what you say, FMEA are a central part of your quality management process. That being so, I would definitely deploy them in the diemaking end of your process. The die manufacturing stage, being upstream from the forging, is critical to the success of the forging process (i.e. errors in diemaking will cause problems in forging). Under the general quality principle calling for strong upstream controls to prevent / minimize downstream problems, diemaking calls for controls at least as strong -- if not stronger -- than forging. Hope this helps.

What about the new ISO 9001? (3/28/08)

My registrar told me that the ISO 9001 standard is about to change. How can I make the needed changes without a whole lot of hassle?

The changes are rather minor, the way things look. Don't worry about it. At the appropriate time we'll post an easy to follow transition guide. No charge, of course. Keep checking this site!

How much of your management's energy is spent on things that don't add value for your customers? (11/12/04)

This is from the Detroit Free Press, about a law firm that moved from downtown into new offices in the suburbs. Benefits of the move included reduced commuting time and lower costs. But they cited another benefit. . . .

Starting from scratch in new space also allowed the firm to experiment with giving all attorneys offices of the same size, regardless of seniority. Squabbling over who gets the biggest offices has been eliminated. There are no corner offices. Rather than having attorneys feud over them, the firm turned all corner spaces into conference rooms. The practice makes space planning immensely easier.

"When we would move one attorney, it would take seven moves to get him in the right place," Zussman says of the old seniority-driven system, "either because his office wasn't in the right place or they needed a partner-size office or an associate-size office or they needed a larger associate office than a smaller associate-size office. This eliminates all that brain damage."

Are ISO costs tax deductible? (4/20/06)

The answer may surprise you. (Considering what we just went through in our latest tax cycle, it surprised us.) Check out the official IRS Bulletin here.

Must we change our drawings? (4/3/06)

If our company were to change its name from a corporation to a limited liability company, do we then also need to change our title blocks on all of our drawings?

For existing / old drawings, I'd say no, barring any law / regulation of which I'm unaware. I'd put the current name on new ones. Hope this helps.

Just In Time

I WANT TO KNOW, WHAT IS THE MEANING OF "JUSTO TIEMPO" THIS IS IN SPANISH AND I DONīT KNOW HOW TO SAY IN ENGLISH, THIS IS REFERENT WHIT THE QUALITY BUT I DONīT KNOW IN WHAT WAY. PLEASE SEND ME THE CONCEPT AND IF YOU CAN SOME ARTICULS ABOUT THIS. THANK YOU

It means "just in time." Just-in-time (JIT) is a concept wherein manufacturers organize their production processes to produce product for customers precisely when they need it, rather than building inventories and shipping to customers out of them. It cuts the cost of building and maintaining inventory and tends to make the production process much leaner and more reactive to customer needs.

Software Testing

I was wondering if you could tell me where to find a document checklist for the testing and accepting of new software before it is installed on a company network?

I'm not aware of any such canned document. Most organizations I have worked with have developed these on their own, specific to their own processes / environments.

ISO publishes a guidance standard (9000-3, 1997) that provides guidelines for applying the quality system requirements to the development of software. I suggest you get your hands on that. It doesn't get so specific as to include checklists, but there is a lot of good guidance in there.

Quality Control vs. Quality Assurance?

What is the difference between a quality control manager and a quality assurance manager?? Please help :) Thank you!!

In practice, I"m not aware of any substantive difference. The terms have become virtually interchangeable. Strictly speaking, "quality control" applies to very specific quality-via-inspection methods and philosophies. "Quality assurance" is generally understood to encompass a much broader range of quality related activities. So I suppose, by strict definition, a "quality control" manager would be chiefly involved in inspection, whereas a "quality assurance manager" would have responsibilities going well beyond that to things such as supplier / vendor control, disposition of nonconformities, warranty work, gage control, etc.

But in the organizations I work with, the terms, as I said, would seem to have become virtually interchangeable.

ISO in Food Service

i own a small chinese restaurant ( 6 employees) and i was if the iso 9000 apply to me and can be helpful to me. if so where do i start?

I honestly don't know, in reality, if ISO 9000 could be helpful to you. An organization that small tends to be run on a very tight rein by on-site ownership; the advantages of a documented system is that it helps management to more effectively communicate its policies and methods to a growing and changing work force. You can start, if you choose, by reading up on the subject -- there are literally dozens of books available (including, modestly, mine!).

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