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7.5.2 Validation of Processes for Production and Service Provision

Validation of Processes is similar to the requirements of 4.9 Process Control of the 1994 standard. There are no significant changes.

Who is best to handle this requirement?
This activity closely aligns with the process of production / process control from a service delivery or manufacturing perspective; therefore the responsibility is best focused between the quality manager, and the production / operations (or equivalent) managers. In a service company this responsibility may fall to a product line manager.

Day to day implementation of "Validation of Processes" must rest with those responsible for the actual management of the individuals and equipment involved in the manufacture / delivery process for the products and services. Therefore implementation will be focused on front line supervision and operational staff.

This Clause will require a high degree of co-ordination with many other departments, and is often best implemented as a team effort. Process structures and inputs are often sourced from manufacturing or design engineering (or service marketing / development) staff. Final delivery is often executed by customer service, sales or field support staff. The process will also include integration of production / service management with materials management staff, scheduling, purchasing and many others.

The Requirement
Validation of Processes states that your company must validate any production and service processes where the output from those processes cannot be verified by monitoring and measuring activities. This includes processes where deficiencies are only apparent after the product is in use or the service is delivered. The validation must demonstrate the ability of your processes to achieve the planned results. The standard states that your company must define arrangements for validation that include the following (where applicable):
a) Qualification of processes;
b) Qualification of equipment and personnel;
c) Use of defined methodologies and procedures;
d) Requirements for records;
e) Re-validation.

"Special Processes"
This deals with a portion of the old 4.9 of the ISO 9001:1994 standard, specifically the "special processes" referred to in the 2nd paragraph of the requirement. You may have had instances of "Special Processes" in your Quality System based on the 1994 version, and if so, this requirement expands on the requirements of the 1994 version by requiring validation of those processes. "Special Processes" as noted in the old standard, refer to processes where the results cannot be fully verified by monitoring and measurement activities (test and inspections from the old standard) and deficiencies may only become apparent only after the product is in use.

The ISO 9001:2000 standard will now require you to go further than just qualifying your "special processes". You must now validate them. The validation is performed to ensure that your processes are able to achieve planned results. This is the major difference in the two standards, a more specific approach to monitoring your "special processes". The documented procedure for the qualification of special process is now superceded by validation. Qualification now becomes only a component of validation.

Service has been included in the new standard as well. Services will have to be more intensely planned and documented especially where their conformance to specified requirements is difficult to determine or impossible until after it has been delivered. Documented methods for implementing and measuring conformance of services should specifically define sub-processes, inputs/outputs, critical characteristics and controls. For example, services that are supposed to provide savings to the customer will now have to have short-term measures, not just the savings in the end.

Your company must now make arrangements (and document them) that ensure qualification of processes, qualification of equipment and personnel, use of defined methodologies and procedures, requirements for records and re-validation for your "special processes". These are the particular conditions under which you should operate in respect to these processes, because by doing so activities will be carried out in a consistent way. It implies control over all the factors that affect your "special processes", including documented procedures. These are not new to the 9001:2000 standard and should all be listed as a minimum requirement of validation.

Timing during implementation
This should be started early in the development of the overall quality system. A great deal of attention and thought must be given to the development, documentation and implementation of this Clause.

Potential Audit Questions

1) Describe examples of any production or service processes you may have that the resulting output cannot be verified by monitoring and measurement activities. Why is it impossible to identify deficiencies prior to use or delivery?

2) How does your company ensure validation for...qualification of processes; qualification of equipment and personnel, use of defined methodologies and procedures; requirements of records and re-validation?

3) Has your company had difficulties in the quality of your products in which the quality cannot be verified before use or delivery? What accommodations do you currently make to ensure that processes achieve planned results? Do these processes work inline with the requirements of 7.5.5 validation of processes from the ISO 9001:2000 standard? What changes must be made?


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