To answer this complicated question, let’s start at the beginning. A non-conformity statement should provide detail for an observed situation where the defined Quality Management System (QMS) was not being implemented as planned. That statement should include:
- The Source of the Audit Criteria- where the audit criteria is stated (perhaps in a document such as the ISO 9001 standard, the organization’s documentation, a customer’s contract, a regulation, etc.).
- The Audit Criteria- a statement of requirements against which the auditor evaluates what is being implemented.
- The Source of the Audit Evidence- where the auditor found the evidence, which triggered the non-conformity report (usually a unique identifier relating to a place).
- The Audit Evidence- the issue or fact(s) that demonstrated there was a non-conformity with the audit criteria or requirement.
“Purchasing procedure, PUR100, rev 3, paragraph 3.1 states that the Purchasing Manager is responsible for approving all production related Purchase orders before release to suppliers.
Purchase Orders # 001223, 001224, 001225, 001225 issued in July 2018, for steel sheet used for stamping had not been approved by the Purchasing Manager.”With the arrival of recent versions of ISO 9001, the requirement for an effective QMS has come to the forefront. Previously, implementing an ISO 9001-based Quality System was frequently described by the mantra, “Say what you do, do what you say, prove it.” This approach caused lots of documentation – manuals, procedures and instructions – to be produced with little regard for any kind of recognizable results (or process effectiveness).
Frequently, audit non-conformities vaguely report that “procedures are not being followed,” leaving management perplexed. With such an ambiguous statement, it is nearly impossible to accurately respond to the non-conformity. Management is left wondering, is the procedure effective, but the people don’t follow it for some reason? Or, are the people effective, but the procedure needs changing so it can be followed?
In cases such as these, it is possible to apply the “So What?” test and still not find clear answers for what the actual issue is. Take the previous non-conformity statement, for example. The Purchasing Manager didn’t follow the procedure and approve those four purchase orders in July. “So What?” one might ask…
What’s missing is information about the impact on the effectiveness of the procedure. In recent years, to fulfill this requirement of including ‘effectiveness’ in their reporting, Certification Bodies (aka Registrars) have used the following phrase for recording observed audit non-conformities:
“Could not be demonstrated as effective…”If we merge the previous non-conformity with this phrase, we get:
“Purchasing procedure, PUR100, rev 3, paragraph 3.1 states that the Purchasing Manager is responsible for approving all production related Purchase orders before release to suppliers and could not be demonstrated as effective…
Purchase Orders # 001223, 001224, 001225, 001225 issued in July 2018, for steel sheet used for stamping had not been approved by the Purchasing Manager.”With this new statement added in, let’s try the “So What?” test again. Are we any better off knowing what the issue is? We know someone didn’t “follow procedure,” but we still have no idea about the effectiveness of the result.
That’s What Gets Results…
It’s no longer sufficient to simply state that something about the Quality Management System isn’t effective. It’s much more useful (to management) to report on what affects the results of following a procedure. From the example, we know the Purchasing Manager didn’t approve the Purchase Orders, but what was the result? The effect on those POs could be significant – but from this particular audit report, we’ll never know.
Clearly, as far as ISO 9001 and Quality Management Systems go, the song has it wrong! It is both what you do and the way that you do it! Meaning, while it is important to have the statement of non-conformity, it is just as important to make sure the statement actually means something. As stated in the song, “That’s what gets results!”
We can’t act on something without understanding what the problem is. It’s no wonder that no one wants to receive an ISO 9001 Audit Non-Conformity Report. What’s needed is a more complete audit non-conformity that includes results…
MEET OUR EXPERT
Quality Program Manager
Andy has 40 years of expertise in a wide variety of roles and industries, with a focus on quality management systems in manufacturing organizations. In addition to his ISO 9000 Management Systems experience, he has worked extensively with ISO/TS16949, ISO/IEC 17024 and ISO/IEC 17025. His broad practical knowledge of ‘Quality Tools’ includes: SPC, FMEA, Quality Circles, Problem Solving, Internal Auditing and Process Mapping. He also has been an IRCA and RABQSA accredited Lead Auditor.
Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.