Why the “process Based QMS model ” makes perfect sense

I may as well start with a fitting quote:

“Insanity: doing the same thing over and over again and expecting different results.”

(Albert Einstein)

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“Our system is not working”

   A recurring statement that many have heard at some point. The response in many instances is to tweak a procedure a little, add a new form, etc… Is there a more effective way? I believe so. The “process based approach” gives us a concrete method by which to determine if a process is effectively doing what it was intended to do. The reason is that the very basis of this approach drives a company to ask a very simple and important question about each QMS process. How do we monitor and/or measure whether or not the process is functioning as we want it to? This question leads to determining some objective way to measure the process instead of going off of a hunch or gut feeling.

   A “system” is formed by the interactions of each of the processes that make it up. If one or more of the “processes” that it is comprised of are not operating effectively, the “system” could possibly have the same problem. Our QMS should consist of metrics or objectives that measure each of the QMS processes. These metrics should drive the day to day operation of the process, by the process owner and should be reviewed by management. If there are suspicions that a systemic problem exists, instead of grasping at straws and not performing proper root cause analysis, look at the individual processes and the associated objectives or metrics. If there is a problem, the metrics should confirm it assuming that the correct QMS process metrics have been chosen. 

   In my opinion, one of the greatest improvements in the ISO 9000 based series was the shift to a “Process Based Approach”. The “silo” driven QMS that does not use effective metrics is (or any metrics) is not an effective or value-added manner to operate a business. The choice to define your QMS processes, choose effective metrics for them and act on the data is one of the best choices a company can make.

   Many or most of us may recall the PDCA (Plan-Do-Check-Act) cycle (sometimes referred to as the Shewart cycle). It is used interchangeably at times by some with the PDSA (Plan-Do-Study-Act) or Deming cycle. The whole idea being that you plan how you will do something, check to see how it is performing against the plan, review the results or objectives/ metrics and then take action on the results. This is the “pulse” behind the process based QMS/ approach. Many companies will establish metrics (on-time delivery, customer rejects, etc…) but not tie them to specific QMS processes that drive action (corrective action). The day to day management of the process is crucial to make short term corrections. Equally important, but often forgotten, is the “big picture” review by management (Management review process) to determine if there are “systemic” issues that the “process view” may not reveal. There may be recurring issues being seen by the individual processes that are being corrected from a short term (fire fighting) point of view but not being addressed from a big picture point of view. Management should be reviewing the “system” by reviewing the “processes” as well as the overall performance of the relationship between them. 

   So, how does an organization start the “Process Based QMS” journey? Here is a brief list of the steps in the approach I have used:

1)      Define what it is your business does and the processes that exist (do not overanalyze here – keep the process simple)

2)      Decide who the logical “Process Owner” is. This person should have the responsibility and the authority to affect the results

3)      With the Process Owner and Management, define the objective (can be a monitored or a measured result) as well as the goal that tells you that the process is operating well and as planned

4)      Analyze the process in detail defining the inputs, outputs, information required, governing method (procedure, work instruction, etc…), the resources needed (computer software, dept. resources, equipment, etc…)

5)      Decide how the data on the process will be gathered, by who, how, how often

6)      Define how the results will be monitored by management (Formal management review, other meetings, etc…)

7)      Make sure that the process owner knows how to, and that they are responsible for the continual improvement, corrective action and preventive action of the process

8)      Continue using the P.D.C.A methodology         

   I think most will find this QMS approach to be very interesting and beneficial to the business as well as the quality system.  

Here is to improvement.

Mark