OBJECTIVES FIRST
Any humanly devised process is preceded by an objective. We don’t process things for no reason, we process things to accomplish something. After we are clear about what we intend to accomplish, we develop a process to achieve that objective.
Plan-do-check-act (PDCA) begins at the planning phase of processing. Given the basic process objective, performance objectives might also be established to later help evaluate process effectiveness and efficiency. Also during the plan phase, we devise a processing plan (a way to do it, a procedure). Depending on circumstances, this could be a very complex, highly structured planning process, or it could involve more organic trial and error process development.
Once a processing plan has been developed (plan), we perform or operate the process as planned (do), after which we evaluate the outputs (or results) to see how we did (check). Here, a couple of basic questions are raised about process performance:
- To what degree did the process accomplish our objective? Or, how acceptable is the result/output? These questions relate to process effectiveness: did the process work?
- How efficient was the process? This question relates to an analysis of results accomplished versus resources expended: did the process waste?
If process performance was perfect and the expected product came out exactly as expected and no waste was produced, then there would be no adjustment necessary to the plan (ACT). The plan for next time would be to do it just like we did it last time.
On the other hand, if performance was less than perfect, there is an opportunity for improvement. Whether or not this opportunity should be pursued is a question for management to answer. If improvement is desirable, something needs to be adjusted in the plan (or the execution of it). Otherwise, the plan is effectively to repeat the same performance and achieve the same results.
UNDERSTOOD APPROACH
The problem with ISO 9001, in a nut shell, is that companies often didn’t associate the PLAN phase with their own operating procedures (i.e., their planned arrangements for accomplishing processing). Successfully managed companies were already naturally applying a process approach, but when the standard came out requiring documented procedures, companies commonly abandoned the idea of documenting their own operations in favor of buying or copying “proven out-of-the-box” management system documentation. It seemed the easiest, quickest way to “get certified.”
It was neither. Using an out-of-the-box set of documents to define their own management systems may have seemed at the time to be the clever option. (It was often the sole option available.) In the end, those choosing this option out-clevered themselves. They would have been more clever to simply document what they do everyday and make improvements where it makes sense—something they were going to do anyway if they planned to stay in business. Instead, they went out of their way to prove ISO 9001 conformity with a bad idea of what the standard required.
Companies should have sought to document their management systems in an effort to remain competitive by systemically managing, controlling, and improving operations by smart application of PDCA. That would have resulted in documentation that makes quality management transparent in operations. Done this way—from a desire have good quality management—ISO 9001 certification is no problem. This way, effort goes into managing and improving the system, like it was before ISO 9001 came along, instead of being allocated to struggling with a dysfunctional management system to keep a certificate on the wall.
Implementing a management system using the common ISO 9001 clause-by-clause approach (or six procedure only approach) is NOT a process approach to quality management. It’s a bad approach to ISO 9001 certification. It’s a standard-based, or “out-of-the-box” approach, which contradicts the process approach required of the standard, the same approach demanded of good sense. The out-of-the-box approach is basically very cheeky cheating. It’s confusing, costly, and senseless. It’s no wonder companies commonly hold ISO 9001 and those associated with it in low esteem.
A BAD JOKE
Although a quality manual and procedures describe the operation of a management system and its processes, the “out-of-the-box” system that so many ended up with had no chance at actually describing their own processes and operating procedures. These documents were too busy simply describing how operations comply with the individual clauses and subclauses of ISO 9001–thus missing the point of management system documentation.
At the process level of a management system, the current PLAN for how to accomplish processing–the specified way to transform inputs into outputs–is a procedure. A document designed merely to answer ISO 9001 requirements is not a procedure. But these documents still pass as procedures, while management systems composed of these documents still pass as quality management systems.
Without a process approach, ISO 9001 (and quality management) is a sham. It’s a joke.
Regardless, consultants and auditors who don’t promote a process approach—promoting instead a self-serving out-of-the-box approach—make out very well for themselves financially. The challenge is they may be unaware of the troubles they cause for their clients and the damage they do to ISO 9001 and quality management as a profession.
Bio:
T. D. (“Dan”) Nelson has been closely involved with ISO 9000 since 1994 as a technical writer, quality manager, management representative, consultant, author, and CB auditor. Holding an MA in Business Administration from the University of Iowa, Dan also has 12 years of experience as an IRCA-certified QMS Lead or Principal Auditor, conducting registration audits and surveillance audits, and training Lead Auditor candidates in accredited courses. Using a process approach, Dan has taken several scores of clients of various shapes and sizes through registration to ISO 9001:1994/2000/2008 and related sector schemes (e.g. QS 9000, AS9100, ISO 13485, and ISO 17025). Dan’s numerous articles about the process approach have also been published by Quality Digest, Inside Quality, ASQ’s Quality Management Division, the Society for Manufacturing Engineers (SME), and the South African Quality Institute (SAQI); Dan has been featured as a guest blogger by RABQSA, and has been featured on Quality Digest Live. Dan is available for management consulting, training, and coaching, as well as auditor training and coaching. Contact: dan@tdnelson.com 720 412 7994