Two separate events over the past couple of weeks caused me concern. First someone told me that we must consider auditing conformity as being equally important to the consideration of effectiveness since both were required. The statement caused me to pause. True I thought, the standards are full of requirements for conformity.
This statement reminded me of the other event, which had happened previously. Someone had pointed out that the IATF standard specifically asks for measures of efficiency and measures of effectiveness and that their auditor interpreted that requirement as meaning that each and every process had to have specific measures for both.
These two events spurred this article. Are the interpretations described correct?
It is my intent in this article to analyse the requirements for conformity, for efficiency and for effectiveness in an effort to clarify what the standards do say about these subjects and how a rational (i.e. critical) thought process would interpret them.
I spend much of my time teaching people who work in the automotive industry about management systems and the requirements for auditing them. In my training, I make a concerted effort to stay away from counting shalls and telling people what they have to do in order to meet the requirements of the standards. I try hard to focus on the intent of the standards. It is my belief that the ISO 9001, ISO 14001, OHSAS 18001 and IATF 16949 standards which I spend most of my time discussing were written with specific objectives in mind.
The ongoing ‘Quality Lawyering’ approaches that often occur in the QMS training, Consulting and Auditing businesses seriously concerns me. The constant counting of shalls, the detailed analysis of where lines go on ‘Process Maps’ and the constant debate over how instructions are written only serves to promote the idea that these standards are only there to generate work for registrars and consultants. In generating non-value added work it creates an illusion of these being non-value adding standards. I believe that most of this unnecessary noise in the system is there for one of two reasons.
First it is required so that the systems and the requirements of the standards will appear complicated. This of course drives the need for outside support. That is to say, business and profit for the consultants, trainers and registrars.
The second reason is, either it’s too difficult to understand the intent of the standards or more likely we choose not to take the time to understand them in the first place. It is obviously much easier to read the words and react to the first notion that comes or accept someone’s rote interpretation as gospel rather than actually study the standards from the perspective of management and desired performance.
In this article, my focus is the automotive combination of ISO 9001:2015 and the IATF 16949: 2016 standards. The objective of these standards, in my opinion is in simple terms to encourage the development of systems within organizations (and within the chain of suppliers to the OEMs (Original Equipment Manufacturers)), that will result in higher quality products and more efficient and more reliable delivery of those products.
Conformity
The ISO and IATF standards use the word conformity a lot. They use the word nonconformity or nonconforming even more but in this article, I have chosen to ignore the nonconformity references simply because lack of efficiency, lack of effectiveness, lack of adherence to a specific customer requirement or lack of specific evidence for a requirement would all constitute a non-conformance or nonconformity.
There are a total of fifty references to conformity in the combined ISO 9001/IATF 16949 standards. In addition, there is one in the IATF rules. Of those fifty, thirty-eight of them specifically refer to conformance of product. The full list is available in our Process Audit Toolkit. Therefore, there are only twelve references that may require conformity other than conformity of the product.
Six of the remaining twelve references to conformity refer to conformance to specific customer processes. They are:
1) Conformance to MSA processes 2) Conformance to prototype processes 3) Conformance to PPAP processes 4) Conformance to statutory and regulatory requirements 5) Conformance to Control Plan requirements and 6) Conformance to batch control methodologies.
The remaining six references to conformity fall into two general categories. Two that refer to conformance to the QMS of the organization and four that refer to conformance to the standard. But, the standard emphasizes conformance to the requirements of the product and conformance to customer specific requirements as we have shown. In addition, as we will see the standards emphasize effectiveness and efficiency.
Therefore, doesn’t the requirement to conform to the standard by association mean the efficient and effective conformance of the product and conformance to customer requirements? Isn’t conformance to the standard and conformance to the requirements of the product, conformance to customer specific process requirements and the application of effective and efficient processes the same thing?
Let’s talk about effectiveness and efficiency for a moment because it seems apparent that this too is an area that needs critical review.
Efficient and Effective
Within the ISO/IATF standards there are twenty-four references to effectiveness and another four referencing efficiency; two of which reference efficiency and effectiveness together. A full list is available in our Process Audit Toolkit.
According to common definitions as applied to systems:
“A process is efficient if it provides adequate valuable and profitable results. Is done in a useful, productive, well organized, systematic way, by able, skillful, competent, capable, people who are proficient and economical in their functions.”
“A process is effective if it meets all of the requirements for efficiency and the resulting performance is valid.” That is to say, it meets the intended ends.
In the automotive industry, it must be accepted that the intended ends would require meeting the requirements and expectations of the customers as well as those of the organization.
To determine performance for both efficiency and effectiveness there would first have to be evidence of valuable performance. There would have to be data which showed adequacy, validity and profitability and there would have to be evidence of competency of the personnel involved. Then, if the organization’s performance data showed that the organization’s performance meets their targets, including profitability, the processes must be considered adequate and valuable and by the simple fact that it meets those targets, efficient.
If the process is planned and implemented in accordance with the customer’s performance expectations (run-at-rate, production rate, quality PPMs, delivery, MTBF, MTTR, etc.) and data shows that customer expectations are being met, then the process must be considered effective.
There is therefore no specific requirement for each process to have efficiency performance and effectiveness performance. There is a requirement for the QMS of an organization to be both efficient, which means that the organization’s QMS meets its objectives including profitability, and effective which means that the QMS is efficient and meets the customers’ expectations. There is of course a requirement to improve both efficiency and effectiveness.
Summary
Therefore, if the organization’s QMS provides conforming product to its customers; if it complies with specific process requirements defined by the customer and any specific requirements defined by the organization, then is it not an efficient, effective and conforming system?
If this is true, then why do we spend so much time and effort in discussing the right way of how? Why do auditors, consultants and the customers themselves spend so much effort telling organizations how they should run their companies.
If organizations can show efficiency, effectiveness and conformance, then they meet the requirement and by consequence are a valuable resource to the customer. If they cannot show efficiency, effectiveness and conformity then they do not meet the requirement of the ISO and IATF standards and effective action is required in order to achieve these expectations.
Discussion about where a specific line on a process map goes or should go, does not improve effectiveness, efficiency, product conformity or compliance to a customer expectation? Yet I have personally seen auditors who wanted to write a non-conformance because he thought a line on a process map didn’t go to the correct box.
How does a non-conformance written because an organization doesn’t have a measurement for every process that measures efficiency and another that measures effectiveness help to achieve the desired result? How does an audit of shalls provide conforming product, conformance to customer expectations, efficiency and effectiveness?
Unfortunately, there is a chain of responsibility from the original customers of the IATF requirements through to the intended providers. In too many of these steps it is certainly possible given the anecdotal evidence, that the profit motive achieved through driving complexity, driving non-value added work and implementation of bureaucracy can and does not only reduce the effectiveness of the IATF effort but masks its potential value.