5.8 Nonapplicability of Specific SHALLS


5.8 Nonapplicability of Specific SHALLS

Aside from the issue of exclusion, where we might need to exclude key functions such as either design and development or after-sales servicing, in those cases where a specific SHALL is not applicable (i.e., not appropriate to the organization's structure), a discussion is necessary that clarifies the reason for its dismissal. This is contrary to the general feeling that one should just ignore the requirement. One can do this, but the loss is in the ability to clearly communicate enterprise policy. Consider a more positive approach to such issues.

Positive Approach to Nonapplicable SHALLS

Clause 7.5.3 Identification and Traceability In this case, our company is not required to maintain traceability by either our customers or by some industrial Standard under which we operate. A positive approach can be used to clarify the nonapplicability of the SHALL and to state what actually occurs operationally.

Clause 7.5.3 example response: Although traceability is not a contractual requirement of FLS Enterprises, Inc., the company considers traceability an integral part of its quality mandate. As a result, all final products are serialized and all key components integrated into its systems are serialized. A record of all serial numbers is maintained by quality assurance as part of the system history record during final test and inspection.

As another example, consider a positive response to 7.5.5: Preservation of Product in that we are to preserve the conformity of our product during its delivery to the customer's dock. This clause implies that we are to extend product quality protection beyond the plant. A positive approach would be to state that, "The Excellent Corporation considers product quality paramount in our customer relationships and the level of protection of all product shipped is determined by quality-assurance laboratory testing to the appropriate international standard, as necessary." This type of statement puts the customer at ease and implies that you are someone they can negotiate with productively.

Contrast this approach with the alternative (negative) dogmatic statement "F.O.B. [free on board] is always established at the Excellent Corporation's dock." Now the customer will wonder what difficult type of negotiations they are apt to run into with this supplier who sees the world without shades of gray.

Clause 7.4.3 Verification of Purchased Product The same approach can be used in the case of Clause 7.4.3: Verification of Purchased Product in that our company does not perform source inspection and would rather not have our customer audit our suppliers. The positive response might be, "The Excellent Corporation does not consider it necessary to perform source inspection on our vendor's products because they are qualified initially by a potential supplier survey and are required to provide certificates of compliance with each shipment."

The negative response might be, "The Excellent Corporation does not require source inspection." The customer will wonder just how you control your subcontractors—or do you?




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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