In April 1998, the Big Three released the third edition of Quality System Requirements QS-9000 and the second edition of the Quality System Assessment manual. While they include many changes, both editions amount to a gradual evolution rather than a revolutionary ratcheting up of quality system requirements. QS-9000's second edition becomes obsolete Jan. 1, 1999, and suppliers registered to it must ensure that their quality systems are in conformance with any new third- edition requirements by their first 1999 surveillance audit. Registrars indicate that they will continue to audit against the second edition of QS-9000 until Dec. 31, 1998. The Big Three have indicated that a supplier can ask its registrar to conduct QS-9000 audits against the third edition before then, and companies should use the updated QSA checklist for internal audits. Companies may update their systems without fear of nonconformance because none of the third-edition changes eliminate or contradict requirements in the second edition. Overall, four modifications stand out in the new edition of QS-9000:  Most changes make the requirements more effective and easier to understand. The International Automotive Sector Group's Sanctioned QS-9000 Interpretations, which are incorporated into the new edition, clarify requirements. Editorial changes, while not altering requirements, make their intentions clearer. The glossary has been expanded by 85 definitions.
Several changes involve moving and consolidating QS-9000 requirements. Grouping similar requirements together under single headings makes conformance easier and eliminates redundancy. New requirements and "notes" have been added, some of which are broad and applicable to all operations, others specific to an operation within all or some suppliers. Many changes clarify how registrar auditors should view QS-9000's requirements and conduct audits. Supplier Quality Requirements Task Force members say they believe some registrars haven't been conducting effective QS-9000 audits. I think the following eight changes to QS-9000 will be useful for both QS-9000-conforming companies and ISO 9000- registered companies to consider in seeking to evolve beyond the baseline: 1. Information to Management (4.1.2.5) -- a new requirement. If a product or process becomes "noncompliant with specified requirements," management responsible for corrective action must be informed as soon as possible, thereby accelerating corrective action (and even preventive action). 2. Analysis and Use of Company-Level Data (4.1.5) -- a revised subelement. Under the requirement for documenting operational performance, QS-9000 adds "cost of poor quality" to the list. The glossary defines the term as "costs associated with production of nonconforming material" and references ISO 9004-1 for additional guidance. 3. Product Safety (4.2.3.4) -- a new requirement. A company must incorporate due care and product safety in its design and process control policies and practices, and promote internal awareness of safety issues relative to a product. 4. Cleanliness of Premises (4.9.b.1) and Contingency Plans (4.9.b.2) -- new requirements. The first requires companies to maintain proper production environments to prevent potential nonconformities due to working conditions. The second requires plans to prevent work interruptions due to problems that can be foreseen and prevented. 5. Maintaining Process Control (4.9.2) -- a reworked subelement. This eliminates the need for subelements 4.9.2, Preliminary Process Capability Requirements, and 4.9.3, Ongoing Process Performance Requirements. 6. Supplier Laboratory Requirements (4.10.6). The third edition adds six requirements specifying quality system requirements pertinent to in-house laboratories that test product and/or provide calibrations. The requirements serve as the basis for applying QS-9000 to laboratory activities as part of a company's overall proc-esses. They are linked with Calibration Services (4.11.2.b.1), which requires suppliers to use qualified laboratories for calibrating inspection, measuring and test equipment. Note: Ford doesn't require these. 7. Mistake Proofing (4.14.1.2) -- a new requirement. Mistake-proofing methods must be incorporated in suppliers' corrective and preventive action processes. These methods must address quality system and product problems encountered and prevent problems associated with risks inherent in the process or product involved. 8. Electronic Communication (4.15.6.3) -- a new requirement. Suppliers are required to maintain a computerized system for receiving customer planning information and shipping schedules. The above changes are all common-sense additions that will help suppliers move toward producing zero defects. However, all third-edition changes should be considered to determine which ones will impact your company's system. About the author Jim Mroz is senior editor of The Informed Outlook, published by INFORM, 15913 Edgewood Drive, Montclair, VA 22026; telephone (703) 680-1436, fax (703) 680-1356, e-mail jmroz@quality digest.com. |
