by Janine Johnson and Paul Palmes
There are many requirements within ISO 9001:2008, but none as universal and all-encompassing as clause 4.1. It is the “heart and soul” of the standard. Its elements echo throughout the standard, moving through the plan-do-check-act (PDCA) cycle and defining a continual improvement engine. In turn, it stands as the auditable equivalent of clause 0.2, the process approach. However, for all its significance, there are few auditors who issue findings against one or more of its elements.
“The organization shall:
- a) Determine the processes needed for the quality management system and their application throughout the organization,
- b) Determine the sequence and interaction of these processes,
- c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
- d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
- e) Monitor, measure (where applicable), and analyze these processes, and
- f) Implement actions necessary to achieve planned results and continual improvement of these processes.”
The PDCA cycle is represented as follows: elements a) through c) establish the plan. Element d) describes things that must be done. Element e) is represents the “check” portion of PDCA and f) the “act.” World-class implementation is a pleasure to audit as each major process within the company is often flowcharted or process mapped to satisfy the requirements in a) and b). In turn, each process is then assigned a set of performance criteria (clause 4.1 c), charted monthly, and posted on performance boards. The internal auditors use these criteria to satisfy clause 8.2.2 b), objectively assessing if the process “is effectively implemented and maintained.”
How else could these internal auditors objectively make that assessment? Without clause 4.1 c) requiring criteria to ensure that the process operation and control is effective, clause 8.2.2 b) is left to conjecture. In organizations where clause 4.1 c) is fully implemented, often through a performance matrix or similar accountability tool, the auditor is actually monitoring whether process performance is in conformance with planned expectations. If that sounds familiar, it should. Those words are taken directly from ISO 9001’s clause 8.2.2 a), Internal audit.
Further down, in clause 4.1 e), is the requirement that processes be monitored and measured (where applicable). Monitoring and measurement includes more than the implication of setting targets, timelines, and other particulars—measurement cannot be performed without them. The bottom line is that clause 4.1 e) relies on clause 4.1 c) for implementation. Where else is this criteria mentioned in the standard, especially in regard to the “gift” that established criteria provides the auditor? Look first to clause 7.1, Product realization:
“In planning product realization, the organization shall determine: c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance.”
For the umpteenth time, “product” is defined as “the output of a process.” In other words, clause 7.1 defines the specifics of what should be considered when developing and implementing an effective process. “Criteria for product acceptance” is therefore one, and perhaps the most important, aspect of an effective process: it should produce an acceptable output (product). Does the phrase “Output Matters” ring any bells? As auditors in search of providing audit value, few elements of ISO 9001 offer greater opportunity for improving performance than clause 4.1 c) and clause 7.1 c).
Processes that do not have performance criteria are subject to findings against clause 4.1 c), as are process outputs without clearly defined criteria, as outlined in clause 7.1 c). That these two sections of the standard are related is confirmed in the opening sentence of clause 7.1: “Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see clause 4.1).” This relationship can be considered as “parent-child” in that clause 4.1’s elements apply to the system of processes and clause 7.1 applies to each process within that system.
Of course, clause 4.1 and clause 7.1 are utterly generic elements, applicable to all processes in the quality management system (QMS). Specific requirements are also found in design, purchasing, validation of processes for production and service provision, internal audit, and monitoring and measurement of product. We’ll let you do the homework in each of these sections, which will improve your skills as an auditor in these specific areas. Where criteria is required, ask for it. If it’s there, audit against it. If stated criteria is not achieved, ask to see what plans are in place to improve process output. It’s required that you do so in yet another section of the standard, clause 8.2.3, Monitoring and measurement of processes:
“The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.”
Given the above, the duty of the auditor is to ask for an improvement plan in the event that criteria are not achieved. At a minimum, expect to see some form of correction plan. If nothing is being done to meet criteria, it would be appropriate to generate a nonconformance.
We know of few auditors who’ve ever issued a finding against one or more of clause 4.1’s requirements. If this article has had the desired effect, that will change—as will the significance of your audit report. On page 121 of Out of the Crisis (MIT Press, 2000), W. Edwards Deming states, “The most important figures that one needs for management are unknown or unknowable… but successful management must nevertheless take account of them.” In other words, established criteria may not be sufficient for management to make an informed decision. Regardless, the criteria that are available are a vital first step to measuring process and ultimately, system performance. At a minimum, an audit must affirm and examine existing criteria and press for Deming’s unknowns when they are not available.
About the authors
Janine Johnson has 20 years of experience in the manufacturing indsutry and presently works as a freelance quality management systems consultant, instructor, and lead auditor. She specializes in the aerospace industry. Contact her at firstname.lastname@example.org.
Paul Palmes is president of Business Standards Architects Inc. of Fargo, North Dakota. A member of the U.S. TAG to ISO/TC 176, he serves as convener of WG 1, SC 1, of ISO/TC 176, which is responsible for future revisions of ISO 9001 and was the U.S. lead delegate and working group secretary during the development of ISO 10014. Contact him at email@example.com.