SYSTEM DEFINITION
If a management system has been defined in standard-based fashion, according to the clauses of ISO 9001, the system demonstrates a lack of effective application of both RBT and a process approach. Uniformly addressing ISO 9001 requirements does not equate to effectively, systemically addressing those requirements from either a process approach or RBT perspective.
Definition of a clause-by-clause QMS defies a process approach, as it divorces definition of the system from actual operations while marrying it to the requirements of ISO 9001. QMS procedures are supposed to describe actual processes needed by a system to output quality product and service. When QMS requirements are expressed in procedures correlating to the clauses of the standard, instead of being incorporated to operating procedures describing processes’ planned arrangements, a process approach has not been demonstrated. A non-process approach has been demonstrated instead, an approach that does not meet ISO 9001 requirements (nor the intent of the standard in any of its revisions).
Not only does standard-based QMS definition defy a process approach, it demonstrates a lack of effective RBT. Because the requirements are generic, as are the risks they represent, defining a QMS to uniformly address these risks shows that management is allowing (and expecting) a uniform standard for assessing QMSs to adequately identify risk to quality in any QMS, regardless of its context.
In reality, some requirements may have great impact on an organization, while other requirements may have little application or impact on that same organization. A standard-based arrangement shows that organizational context was not taken into consideration in defining the system. Echoing the common mistake with failing to apply a process approach, RBT is being addressed merely as required by the letter of the standard, instead of being addressed as really needed for the operations of the company.
On the other hand, the structure of a system defined by the process approach reflects the operations of an organization (not the requirements of ISO 9001). Processes are viewed and managed (and defined) as processes, pursuant to the plan phase of the PDCA cycle. The process approach enables PDCA to get a foothold in operations to control and improve performance.
The inputs to and outputs from each process composing the system reconcile in a description of how the system operates. Documented information defining the system and its processes provides a coherent description of a system outputting product or service, a system composed of processes, the plan for each describing how inputs to the process are transformed into outputs needed by subsequent processes, culminating in release of product or service to customers.
Systems defined using RBT and a process approach are systems designed to consistently output quality product and service to customers. Evidence of applying RBT and the process approach can be found within the architecture of a management system and in the documented information describing it.
ACTIONS TAKEN
Once a management system has been confirmed to have structurally demonstrated RBT and a process approach, further evidence of RBT and a process approach can be found by looking at management decisions and actions, however they have been defined and recorded (e.g., in management review minutes, in daily production meetings, in corrective actions, preventive actions, mitigating actions, improvement actions, etc.).
Were management actions relevant to the QMS effective in addressing the problems, potential problems, or opportunities posed to the organization? If so, it would appear that the PDCA cycle has been satisfied—here is evidence of effective “A” (action) to improve something about the system or the processes composing it. At the same time, effective (and efficient) actions demonstrate effective RBT. Effective, efficient actions are no accident; they result from planned, managed actions.
Management must have taken into consideration what actions might be effective, given the circumstance, weighing options and considering consequences, not trying to overkill the problem while at the same time effectively dealing with it. Every effective, efficient action is evidence of effective application of RBT.
On the other hand, if actions were not effective (e.g., known problems routinely persist or potential problems are routinely realized), or actions were not efficient (e.g., they were unduly cumbersome, restrictive, or costly but implemented anyway) how can we conclude effective RBT was applied? Neither demonstrates effective RBT.
Of course, nobody wins them all. Some solutions management chooses to implement, either reactively or proactively, will turn out to be bad ideas. We can hope management learns from these mistakes and improves. Even companies with sound RBT will occasionally make a mistake by failing to properly consider all possible consequences of the actions they choose to take.
APPLY GOOD SENSE, PROVE RBT
RBT seeks Goldilocks solutions: not too hard, not too soft, but just right. Not too much, not too little, but just the right amount of: documentation and detail, training, incoming inspection, throughput . . .
It will be up to auditors to apply good judgment to determine if the preponderance of the evidence supports a claim of effective application of RBT and conformity to RBT requirements. For any company staying in business, it would appear management must apply RBT at least well enough to keep afloat. It seems unlikely that auditors will be raising findings against RBT requirements in companies with well-defined management systems and graced with management that exercises good sense when taking actions.
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