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Slide 92 of 262


8.3 Control of Nonconforming Product

The company shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery......

Also see 4.2.4.

Element 8.3 is very similar to element 4.13 - control of nonconforming product, of the old standard. Element 8.3 states that your company must ensure that product that does not conform to requirements is identified and controlled to prevent unintended use or delivery. This activity must be defined and documented in a procedure.

Paragraph 2 of 8.3 states that nonconforming product must be corrected and subject to re-verification after correction to demonstrate conformity.

Paragraph 3 of 8.3 states that when nonconforming product is detected after delivery or use has started, your company must take appropriate action regarding the consequences of the nonconformity.

The final line of 8.3 states that it will often be required that the proposed rectification of nonconforming product be reported for concession to the customer, the end-user, regulatory body or other body.

This element focuses on ensuring that product(s) or service(s) that do not conform to the specified requirements are prevented from unintended use, delivery or installation. It is therefore associated with Monitoring and measuring and operations control. The actual requirements for the control of nonconformity do not change from the 1994 edition of the ISO 9001 standard. The real difference are subtle, though some of the wording is better for service companies, such as the words 'corrected and subject to re-verification rather than 'reworked' so that this requirement fits better with services. The requirements of the current section 4.13 of ISO 9001:1994 are also slightly expanded to include services by changing from "nonconforming goods" to "nonconformity."

Nonconformance will be covered in two ways: firstly, quality and / or operations management will develop the procedures that define how these issues are dealt with. Secondly, implementation will cover ALL areas within the company - those having responsibility for ensuring conformance (e.g. operators, inspectors etc.) - as well as all others who may OBSERVE non conformity, such as management, internal auditors, supervisors etc.

Responsibility includes indicating who it is that develops the procedures to handle this element, who is responsible for identification of non conformances, and who is responsible for agreement on action / disposition.

Corrective and preventive actions are now placed in several spots in the new standard. The intent is to steer away from the idea that only nonconformity should start corrective and preventive actions. Instead, your system should be proactive and seek out areas where corrective and preventive actions should be taken. The people running your processes should be encouraged to report all real and potential non-conformities.

This element should be introduced early in the development and implementation. Focusing on existing nonconformances - even before the quality system is fully completed, will assist in providing information to improve processes and other activities. It will assist management in early identification of the opportunities for improvement from current practices.

Potential Audit Questions:

1. How well is your control of nonconformity working now?

2. Is your staff well trained in raising nonconformances? How thorough is your staff in raising nonconformances, do they miss potential or actual nonconformances or do they raise too many that do not add value?

3. Is your management team proactive in looking for potential problem areas?


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