Controlling Production and Service Provision
In my June and July columns ("Take Advantage of Subclause 7.3" and "Process Design Controls"), we reviewed the use of ISO 9001, subclause 7.3, on design and development, to establish product characteristics that meet customer and other requirements. Last month, we discussed the controls required to ensure that purchased product and outsourced processes meet requirements ("Outsourcing? The Buck Stops With You."). We now arrive at the last link in a long product-realization chain. If we design the product well, and properly control purchased product and outsourced processes, we've come close to satisfying our customers. But if we're responsible for product production and service delivery, we still must do a good job producing the product or delivering our service.
Organizations claiming conformity to ISO 9001 must have adequate controls for the product production and service delivery activities that they perform. Understanding subclause 7.5 is simple. It's summed up in the first sentence of 7.5.1: "The organization shall plan and carry out production and service provision under controlled conditions." Subclause 7.5.1 also gives criteria for that state of control. It stipulates that controlled conditions must include, as applicable:
"a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities."
Subclause 7.5.1 requires organizations to think in detail about the processes for production and service provision. They determine what's required to ensure that each process operates in a state of control. What's needed here aren't orders from supervisors, but controls that are carefully worked out with the active involvement of the workforce.
Subclause 7.5.2 requires validation of processes where the product can't be verified by subsequent monitoring or measurement. In such cases, quality depends on the ability of the process alone to meet requirements. In addition, any requirements for periodic revalidation must be established. Of course, there's the belief that achieving a high degree of process capability is the right thing to do because it's more economical in the long run if volume supports the approach. For this reason, it's common in some industries to validate many normal production processes and avoid the cost of subsequent inspections.
Subclause 7.5.3 requires identification of the product by suitable means throughout the product realization. The product verification status also must be identified so it's clear which required measurement or monitoring has or hasn't been accomplished. Where required, traceability identification must be controlled and identified. The objective is to know the identity, status, and, where required, traceability information at all times.
Subclause 7.5.4 requires that an organization control items that belong to the customer, including intangibles such as intellectual property.
Subclause 7.5.5 requires preserving conformity of product through proper approaches to preservation and protection. It makes no sense to produce a product only to see it destroyed or seriously damaged during storage or transport. It's important to think through the conditions to which the product will be subjected after it's completed, and to decide what protection and preservation actions should be taken. This clause simply extends the requirement for reasonable controls to the period between the time that the product is completed and when it's used by the customer.
Thus, the basic idea of subclause 7.5 is to establish and maintain a state of control related to achieving and preserving conformity to product requirements. But the system elements needed to make certain that the organization can consistently deliver product that conforms to customer requirements go well beyond clause 7. In fact, it takes the whole system to do this.
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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