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Selecting acceptable quality levels

I'd like some guidance on selecting an acceptable quality level and inspection levels when using sampling procedures and tables. For example, when I use MIL-STD-105E, how do I to decide when I should use GI, GII or S2, S4?

--Confused in Columbus

W. Edwards Deming observed that the main purpose of MIL-STD-105 was to beat the vendor over the head. "You cannot improve the quality in the process stream using this approach," cautions Don Wheeler, author of Understanding Statistical Process Control (SPC Press, 1992). "Neither can you successfully filter out the bad stuff. About the only place that this procedure will help is in trying to determine which batches have already been screened and which batches are raw, unscreened, run-of-the-mill bad stuff from your supplier. I taught these techniques for years but have repented of this error in judgment. The only appropriate levels of inspection are all or none. Anything else is just playing roulette with the product."

ISO 9000:2000 vs. ISO 17025

I work for a metrology/calibration laboratory that is registered to ISO 17025. I'd like to know what the value is of moving forward with ISO 9000:2000 registration if our company is already registered to ISO 17025.

--Frazzled in Fresno

The value would depend on why your company pursued accreditation to ISO 17025. "If it did so to satisfy customer requirements, then there's no value in obtaining registration to ISO 9001:2000 at this time," recommends Jim Mroz, editor of "The Informed Outlook" newsletter. "I would recommend that you instead conduct a gap analysis of your company's existing quality system and fill those gaps over the next year or so in a way that will result in full conformance with the requirements of ISO 9001:2000 without an unnecessary rush. If your company pursued ISO 17025 accreditation because it wanted third-party verification of the effectiveness of its quality system and the organization's competencies, then ISO 9001:2000 conformance and registration is worth considering at this time in addition to its ISO 17025 accreditation, as ISO 9001:2000 doesn't cover all the requirements in ISO 17025."

 ISO 17025 provides quality system and "competency" requirements that metrology and calibration laboratories must meet in order to obtain accreditation by a laboratory accreditation body, such as those that belong to the International Laboratory Accreditation Cooperation.

 "ISO 17025 was completed prior to ISO 9001:2000 and is aligned with ISO 9001:1994, although my understanding is that ILAC's member bodies will be involved in revising ISO 17025 in the future to align with ISO 9001:2000," adds Mroz.

 There are significant differences between ISO 17025 accreditation and ISO 9001:2000 registration; they are not equivalent or interchangeable. Thus, ISO 17025 accreditation does not mean that your company is registered to ISO 9001:1994, even though it must meet most of ISO 9001's requirements to qualify for lab accreditation.

 "The best course that will produce the greatest benefits for your company, unless a customer is requiring your organization to obtain ISO 9001:2000 registration or a potential customer prefers ISO 9001:2000-registered labs, is to evaluate the quality system you already have and are using as part of your accreditation. See where you can upgrade that system to meet the requirements of ISO 9001:2000 in such a way that the resulting system is more suitable to your organization and how it operates and will drive improvement of your processes," advises Mroz.

 "ISO 9001:2000 is completely compatible with ISO 9001:1994 (and therefore ISO/IEC 17025), so there should be no problem caused by your upgrades."

Quality and human resources

We are just beginning to build a foundation in quality with ISO 9001:2000, which I realize requires a culture change. A few months ago, our human resources department launched a suggestion program, but the HR director doesn't want to release the suggestion program to the quality arena. Any ideas on how to avoid the conflict with HR yet move quality forward?

--Bothered in Boston

Why not work hand-in-hand with the human resource suggestion program? "Have all suggestions, companywide, routed through the HR-initiated suggestion program," advises Donald L. Dewar, president of consulting firm QCI International (publisher of Quality Digest). "It would bring a surge of suggestions, which human resources should like. Each suggestion inspired by the quality movement could be identified in some way so that it would also contribute to the quality improvement score card. It could be a win-win-win (quality, human resources and the company) situation.

 "Team suggestions should be rewarded so that each team member gets the same. When a team decides to improve a process, it should notify the suggestion committee of its project. So if someone submits an individual suggestion after that date, the team gets priority for a limited period of time to complete their project and make recommendations. This latter safeguard is to prevent someone who knows what the team is doing from 'stealing' an idea and submitting it to the suggestion program as their own."

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