MEET BOB’S MACHINE
Bob’s Machine was operating successfully before ISO 9001 came along. Bob was introduced to ISO 9001 when it appeared among his largest customer’s supplier requirements. Although the requirements of ISO 9001 were unclear, the requirement to become ISO 9001 certified needed no clarification.
Bob’s objective became to ‘get certified.’ Unknown to Bob, what the standard requires is a demonstrably effective quality management system (QMS). To ‘get certified,’ Bob needed to sensibly document the system of processes currently operating to output product. To Bob, those processes were (in order of appearance): Sales, Purchasing, Receiving, Production, and Shipping.
Before ISO 9001 came along, Bob had a system composed of these five core processes. Each time Bob received a new order from a customer, the order was processed through this system. At Bob’s, each of these five processes was needed to consistently output quality product, so each was part of Bob’s system for satisfying customers. This system was not re-invented each time an order was received (or each time a standard is changed) rather, each order was processed through this defined system of processes, which was robust enough to accommodate all requirements relevant to processing and product quality.
Using a process approach, Bob would document this system with sensible procedures, maybe regarding them as standard operating procedures. Each was viewed as representing Bob’s standard plan for how he wanted a process to operate.
How many procedures are needed to define Bob’s system of core processes? Five. Because Bob said so.
To document his system of core processes, Bob already determined the processes needed for the system: Sales, Purchasing, Receiving, Production, Shipping. These were the core processes at the heart of his business. This system of processes started with reception of customer requirements—an input upon which Bob’s Sales process was designed to operate—and ends with release of quality product to customers (via the Shipping process). It was an effective system of processes working every day to output product meeting customer requirements as it was designed to do.
PROCESS IMPROVEMENT VIA PDCA
Deming says that to continually improve a process, apply the Plan-Do-Check-Act cycle to it (PDCA). Roughly, plan how to perform a process, do the process as planned, check actual performance, and act: adjust the plan toward improvement. Then repeat. PDCA applies to each of Bob’s identified processes.
Roughly, in the plan phase, establish four things: a general process objective, specific objectives or goals for performance, a plan for processing, and metrics conveying actual process performance.
A general process objective must precede any controlled process. We must have an objective for processing, a reason to implement the process. A process objective defines what we intend to accomplish by processing. Bob says the objective of his machining process is “to make good parts.” What does “good” mean, Bob? “Parts that meet print.”
Roughly stated, perhaps, but accurate enough. In the business of making precision-machined parts to print, Bob has a plan for how to consistently make good parts. This plan is already implemented on his shop floor, where the Production process outputs good parts every day. It’s not by accident that the Production process outputs good parts, it’s the result of planning and effective implementation of the plan. Procedures, whether documented at this point or not, are effectively implemented.
Documenting a plan in a procedure provides a foundation for process consistency and transparency in process management. Management’s plan is objectively communicated to processing personnel in a good documented procedure. Documented, a procedure also provides a basis for management to objectively understand and evaluate a defined process. So a good procedure also provides a framework for process improvement. (Improving a plan or a process is much easier if the plan or process was well-defined in the first place.)
During the plan phase, two other types of objectives are established: those for effectiveness and those for efficiency. An effective process meets its process objective. An effective machining process outputs product meeting blueprint requirements. B =ob is interested in knowing to what degree his parts meet print, and how often the process results in parts meeting print. To that end, Bob (informally) tracks and trends, among other things, internal quality rejects and customer returns. These indicate process effectiveness.
Bob also likes to make good parts while consuming as little labor, tooling, and material as possible, too. Bob pays attention to set-up times, turn times, and scrap rates. These indicate process efficiency. So Bob is naturally interested in the effectiveness and efficiency of his Production process. This interest did not arrive with ISO 9001. Without such motivation, would Bob have arrived at top management of a successful machine shop in the first place?
Anyway, also as part of the plan phase of PDCA, now that we have a process objective, a plan for processing, and objectives for effectiveness and efficiency, we need some type of metrics. These will be used during the check phase of PDCA to gage performance of the process. We are in a sense defining “expected results” so we have something against which to evaluate “actual results” in an effort to identify opportunities for improvement later. Of course, it is during the act phase that management is responsible for implementing any needed improvement actions—by adjusting the plan.
The above represents a process approach to establishing a quality management system. It’s a system designed to output quality product. It’s this system that is documented using the process approach. The process approach results in documentation that is structured according to an organization’s own processes, documentation that is designed to implement PDCA.
THE PROBLEM PRESENTED BY ISO 9001
Given the requirement to document their systems, organizations frequently followed the widely-offered advice to define and document their systems according to, you guessed it, the requirements of ISO 9001. Though effective in passing audits (for now), this ISO 9001-based approach opposes a process approach to quality management.
The resulting “ISO” procedures reflect the requirements of the standard, rather than reflecting any organization’s own system of core processes. If Bob didn’t know better, he would be asking how many procedures ISO 9001 requires. The real question of course, is how many procedures does Bob’s QMS require?
“ISO” procedures do not, and never did, describe how any core process is supposed to be performed. In fact, in following these ISO 9001-based procedures, product is never output at all. So procedures supposed to define “business as usual” were defined as something other than “business as usual.” No wonder the confusion.
While work could be said to be performed “in accordance” with procedures meeting ISO 9001 requirements, work could not be said to be performed “according to” management’s planned arrangements. Though the difference may seem subtle, its impact is not. “ISO” systems don’t work for organizations. As defined, they shouldn’t. They are not designed to output product, they are designed to pass audits.
Because “ISO” systems use the standard as their foundation, organizations must work to upkeep these systems. “ISO” systems don’t describe business as usual, so organizations must go out of their way–beyond business as usual–to demonstrate conformity with them.
A QMS is supposed to work for an organization, not the other way around. Good QMSs describe business as usual, providing a mechanism for managing business as usual using PDCA. Following sensible procedures, personnel don’t need to go out of their way to demonstrate ISO 9001 conformity. Good QMSs work for organizations.
For more information about the process approach problem itself, please see:
https://insights.cermacademy.com/2013/10/29-is-iso-9001-working-t-dan-nelson/
https://insights.cermacademy.com/2013/11/30-an-iso-approach-designed-to-fail-t-dan-nelson/
https://docs.google.com/file/d/0B9JfgnGKRwahTXRCMHlzdlUtUTg/edit?usp=sharing
SHORT CURVE BEFORE 2015
If the 2015 version of ISO 9001 is properly applied, “ISO” systems should no longer pass ISO 9001 audits. However, this will require a change in the common mind-set condoning a standard-based approach. Those involved with ISO 9001 need to unequivocally promote the process approach, yet the process approach represents a change in mind-set for many, one that is not easy to achieve. For ISO 9001 to be successful, and for organizations to be successful with ISO 9001, the process approach represents what should be a welcome change.
Even though a change toward the process approach is a change toward immediate improvement, it’s nevertheless a change and something often resisted. There are reasons for that. An article appearing on the Mind Tools website addresses the typical phases of organizational change. The article’s use of the terms “systems” and “processes” could be understood to be consistent with “QMS” and “QMS processes.” Exploring the psychology of change, it appears to offer some insight into this problem. It’s titled, “Change Curve.”
http://www.mindtools.com/pages/article/newPPM_96.htm#sthash.8K9hrQq6.dpuf
The article states: “The fact is that organizations don’t just change because of new systems, processes or new organization structures.”
This would seem consistent with the experience of those who used ISO 9001 to raise their systems. Here, the new systems were actually ill-conceived and should have been resisted. Using ISO 9001 to define their systems, they ignored definition of their existing systems in favor of defining systems that would merely pass audits. The documented system and the real operating system don’t match, and only one of those systems actually outputs quality product. A QMS is supposed to be integrated into that system actually outputting quality product.
Of course, organizations didn’t change, nor did their core processes change with a new set of ‘ISO’ documents based upon ISO 9001. They continued to operate as usual despite the poorly-conceived system documentation.
So the change needed involves a return to viewing processes as they viewed were before ISO 9001 came along to confuse everyone. The 2015 standard will more clearly require a process approach, which represents the easiest way for any organization to meet ISO 9001 requirements. More important than conformity with ISO 9001, it’s a good way for organizations to improve their performance today, while providing a foundation for organizational improvement and success in the future.
Bio:
T. D. (“Dan”) Nelson is a quality management consultant, author, and trainer specializing in the process approach, ISO 9001, and related sector schemes. Dan has roughly 20 years of experience with ISO 9000 and over 15 years’ experience with the process approach. Dan holds an MA in Business Administration from the University of Iowa. Dan can be reached at:
dan@tdnelson.com
319.210.2642