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Tom Taormina

Risk Management

The Future of Quality Management Is Business Success, Part 4


Published: Wednesday, April 15, 2020 - 11:03

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the subclauses of Clause 6 of the standard.

Clause 6. Planning

Using Clause 6 to build organizational excellence and assess risk
Planning is another of the more obtuse words in ISO-babble. In my experience working with more than 700 companies, planning runs the gamut from how quickly and inexpensively you get product out the door to formal organizational plans for each process that have success metrics that are meaningful.

As we discussed in the article on Clause 5, successful planning begins with the principals creating meaningful and immutable vision, mission and values for everyone. You can’t plan a road trip if you don’t know where you are going and how you are going to get there.

In the context of the standard, where does planning begin? Entrepreneurial startups seldom have any formal plan for the success of their organizations. Once they get their funding, the business plan goes in a drawer, never again to see the light of day. For more mature companies, the concept of formalizing the planning process is often the result of ISO 9001 implementation.

For larger organizations, planning may be manifest in expansion plans based on growth in market share. Seldom is quality management planning on the radar screen of senior management. Understandable, since the QMS is typically an overhead expense on the balance sheet.

6.1 Actions to address risks and opportunities

6.1.1 and organizational excellence
It is curious to me that the first step in planning, according to the standard, is actions to address risks and opportunities. In planning for organizational excellence, I would start with developing a strategic plan defining the objectives of the organization and mapping an infrastructure of interrelated processes that would cover every aspect of achieving the overall goals of the organization.

Planning for organizational excellence would subsume that QMS planning is integral with overall organizational planning. The QMS is a strategic component of overall planning, but it is seldom a key element of the organization’s master plan.

The subclauses of 6.1 are right up there with the definition of obtuse.

a) give assurance that the quality management system can achieve its intended result(s)
b) enhance desirable effects
c) prevent, or reduce, undesired effects
d) achieve improvement

I have never understood how to quantify these requirements, and they are clearly intended for compliance, not for excellence.

6.1.1 and risk avoidance
Prevent, or reduce, undesirable effects are not the foundation of effective risk avoidance. Again, I ask why the topic of risk is the first paragraph in “planning.” The only satisfactory answer is failing to plan is planning to fail.

6.1.2 and organizational excellence
This subclause states that the organization shall plan actions to address risks and opportunities. As stated in Clause 4, when defining the infrastructure of the organization and the QMS, the tools of organizational excellence and risk avoidance provide enhanced methods that turn quality management from an overhead expense to a profit center. It more clearly defines the interaction of all internal and external factors so they can be measured and continually improved.

I challenge you to look at the metrics you associate with Subclause 6.1 that define if this conventional planning is returning an investment or is just compliance fodder.

6.2 Quality objectives and planning to achieve them

6.2.1 and organizational excellence
In my opinion, Subclauses 6.1 and 6.2 should be in the reverse order. Quality objectives and plans to achieve them should precede requirements for actions to address risks and opportunities. A big step in achieving organizational excellence is having a strategic plan based on the vision, mission, and values of the principals. 6.2.1 is a viable checklist of what should be included in the quality objectives, but should they not be included in the overall objectives of the organization?

6.2.1 and risk avoidance
Missing from the requirements of this subclause is any mention of identifying foreseeable risk and planning to avoid risk. If risk avoidance is not a mandatory objective, any conformity controls will be less than optimal.

6.2.2 and organizational excellence
Again, this subclause is about compliance, not about creating excellence. It is missing:

f) What is the return on investment?
g) How will the vision, mission, and values be implemented and measured?
h) How will the customer become a referral, not a victim?
i) How will we achieve 100-percent defect-free products and services?

6.2.2 and risk avoidance
When planning how to achieve quality objectives, we need to add:

j) How do we identify foreseeable risk?
k) How do we avoid foreseeable risk?
l) How do we anticipate how customers can misuse our products?

6.3 Planning of changes

6.3 and organizational excellence
Process changes are typically for improvement or to remedy a problem. Given that most companies will not be disposed to do a wholesale initiative to incorporate business excellence and risk avoidance tenets into their QMS, implementing process changes is an ideal time to use the criteria in these articles to test each process to identify opportunities to add value to and to identify foreseeable risk.

6.3 and risk avoidance
As any software developer will tell you, the smallest of changes can have unintended consequences that are difficult to anticipate, find, and remedy. Having been a signatory on many electronic and mechanical drawings, by the time the drawing was at revision H or I, I went back through the revision history to ensure we had not changed a facet back to where it was before.

The same risk questions in 6.2.1 and 6.2.2 need to be incorporated in changes, plus, there needs to be stricter scrutiny of how the changes affect other processes.


About The Author

Tom Taormina’s picture

Tom Taormina

Tom Taormina is a subject matter expert in the ISO 9000 series of standards, having written 10 books on the beneficial use of the standards. He has worked with more than 700 companies and was one of the first quality control engineers at NASA’s Mission Control Center during the Gemini and Apollo projects. He also is an expert witness in product liability and organizational negligence.