Does ISO 9001:2000 require SPC to be conducted at the most critical process


Quite Involved in Discussions
Has anyone seen anything regarding the new standard requiring SPC (process capability) to be conducted at the most critical process? I thought I had read this somewhere...

E Wall

Just Me!
Trusted Information Resource
Hi G, I think you may be referring to 8.2.3 - Monitoring and measurement of processes which reads as follows:
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall domonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

From DNV Interpretation guidebook:
"The ability of a process to satisfy its intended purpose may be based, in whole or part, on some of the following attributes:
  • Repeatability and reliability
  • Timeliness in a process or personnel performing a task
  • The competency level of personnel performing tasks
  • Process constraints related to equipment and/or material availability

Some examples of process monitoring would be:
  • Measuring reaction time
  • Cycle Time
  • Measurable aspects of dependability
  • Efficiency of the process
  • Waste reduction
  • Cost allocation and reduction.

In a manufacturing environment individual processes may utilize measuring devices which provide an indication of the process characteristic (e.g. temperature of a heat treatment oven). This monitoring should be planned to ensure that the oven maintains the material at the specified temperature.

In determining the processes and sub-processes that should be monitored, it is important for the organization to consider all of the activities addressed in clause 7 of the standard."

Michael T

Hi G...

As an addition to Eileen's post, Element 8.1 (Measurement, analysis and improvement - General) states:

"This shall include determination of applicable methods, including statistical techniques, and the extent of their use."

I interpret this to mean that we must determine the methods for measuring, analyzing and improving processes and those methods can include statistical techniques, but statistical techniques are not required. However, whatever techniques are used to measure and analyze processes - how we are using them must also be identified.

Does this answer your question?



Fully vaccinated are you?
> requiring SPC (process capability) to be conducted at the
> most critical process?

That is required within QS-9000. Not in ISO 9001:2000.
Top Bottom