Outsourcing? The Buck Stops With You
In my April column ("Do Customers Know What They Want?"), we discussed ISO 9001, subclause 7.2, on understanding customer requirements. The June column ("Take Advantage of Subclause 7.3") focused on the requirements of subclause 7.3 to control product design and development. In last month’s column ("Process Design Controls"), we reviewed the application of subclause 7.3 to process design. This month we move to subclause 7.4 on purchasing.
Subclause 7.4 requires that an organization claiming conformity to ISO 9001 exercise control of products that are purchased. It requires control of the purchasing process, the purchase documents, and verification of the purchased product. It reads as follows:
"7.4.1 Purchasing control
"The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
"The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation, and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
"7.4.2 Purchasing information
"Purchasing information shall describe the product to be purchased, including where appropriate:
a) Requirements for approval of product, procedures, processes, and equipment
b) Requirements for qualification of personnel
c) Quality management system requirements
"The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
"7.4.3 Verification of purchased product
"The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
"Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information."
(Source: ANSI/ISO/ASQ Q9001-2000)
For purchased product, the basic requirement is that the product is controlled to ensure that it conforms to specified purchase requirements. Control is required in three areas:
• The purchasing process must be defined in a manner suitable for the material or services being procured. The nature and extent of control should be based on the effect of the purchased material or service on the final product. More critical goods and services should receive more attention than items of little consequence. This must provide for supplier evaluation and define the criteria used to select and periodically evaluate suppliers. Criteria are also needed for re-evaluating suppliers. However, the organization has broad flexibility regarding how to do this.
• The purchase requirements themselves must be controlled. The purchasing documents must provide the information needed to clearly communicate to suppliers what the organization wants to purchase. A process is also required to ensure that purchasing documents adequately state all of the requirements for purchased items.
• The purchasing process must include verification of purchased product . Subclause 7.4.3 has two distinct requirements related to verifying purchased products. First is a requirement to ensure that purchased material conforms to requirements. The organization has great flexibility as to how it accomplishes this, including approaches such as certifying suppliers, conventional incoming inspection using sampling plans, 100-percent inspection, and verification at the supplier’s facility.
The second requirement of this subclause relates to situations where verification is performed at the supplier’s facilities. In some cases, it may be appropriate to use the same methods developed to meet subclause 7.4 to control outsourced processes. In other cases, these methods may either be too cumbersome to be practical or less rigorous than is needed.
The overall message is simple: If you buy products or services that will affect your ability to meet ISO 9001 requirements, you must find suitable means to ensure control of the outsourced work. You retain ultimate responsibility for conformity.
From 1997 through 2005 John E. (Jack) West was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176 and is chair of the ASQ Standards Group.
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