What is Quality

There are many "Quality Gurus", and as many philosophies of and approaches to 'quality'.

Product and service 'quality' outcomes can be thought of as a symptom or by-product of the priorities of the Top Management of an organization.

This is the reason for Section 5.4.2 "Quality management system planning" of ISO 9001.
"Top management shall ensure that:
- the planning of the quality management system is carried out in order to meet the requirements in (section) 4.1, as well as the quality objectives, and
- the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented."

See also "Big Q" vs "Little q" Quality

MISC THOUGHTS

If Top Management is only willing to pay lip service and give speeches about quality but will not commit to putting the organizational structures and systems in place that are necessary to achieve and maintain good quality, and if they (Top Management) aren't willing to say 'no' when someone proposes a short-cut in order to meet a date or make another compromise to quality, then it should be no surprise if the result is poor quality, or -- at best -- inconsistent quality. To achieve consistently good quality requires an effective organizational structure, policies issued and enforced by top management, and business processes and systems that are documented, followed, measured/monitored, and used as the basis for continuous improvement.

We are attempting to change the mindset from "quality is chasing today's defect" to "Quality is a set of interrelated business processes that lead to consistent conformance to customer expectations".

We also need to develop an awareness of sampling uncertainty, and that testing only one unit ("Testing is expensive and takes time, you know?") does not necessarily mean that we have any idea what will happen in the population of all units.

"I have never yet seen an inspection problem which would not benefit from the point of view that the product to be inspected was a frequency distribution."
- (G.D. Edwards - mentor to Walter Shewart)

The challenge is in the mindset:

As long as we continue to refer to non-conformances as "quality problems" and look to the "Quality function" to retrospectively fix them, we will always have quality problems.

What exactly is a 'quality' problem? Is 'quality' a line-item on a bill of material and someone just forgets to add it during the production process? No. The things that are typically referred to as 'quality problems' are really problems with one or more of the following business processes and systems:

outcomes of the design process,
identifying customer requirements,
understanding the environment in which a product will be used (see 'requirements'),
the full extent and impact of manufacturing variation (including sourcing),
the lack of manufacturing controls to manage change, or
a design that is not robust to manufacturing and/or sourcing variation.

If every activity is ad-hoc and everyone is left to define their own processes, the result is chaos. There is no predictable flow of information, no agreed and understood hand-offs between processes, and no understanding of cause and effect.

What is more efficient when running a business? A chaotic environment? Or a well-planned environment?

A well-planned Quality System is a set of inter-related Business Processes that bring order to chaos, and which allow the performance of each process to be measured, which in turn supports improvement.

A SIMPLE TEST

When Top Management emphasizes the importance of 'quality' in the organization, here are a few simple questions:

How far down from the top of the Organization Chart must one go before they find a position with the word 'Quality' in the title?
- To whom do they report?
  - CEO/COO ? President ? Vice President ? other ?
- What is the scope of their influence within / across the organization?
  - Are they prohibited or discouraged from working with certain parts of the organization?
How may resources are allocated toward 'quality'?
- What is the scope of their influence and authority?
  - Does their scope reach across the organization, or is it limited functionally, regionally, or otherwise siloed?
What are the 'quality' function resources tasked with doing, and at what level?
- Are they mostly inspectors?
- What influence do they have with product realization (development, manufacturing, sourcing)?
- Do they have influence with the system of Business Processes?
- Whose meetings are they invited to: Local or functional management? Middle management? Top Management?
Has Top Management taken the time to understand the different definitions of 'quality'?
- Have they codified their intent toward 'quality' in a policy that clearly defines the intent for the entire organization?
- Do they have business objectives that are related to 'quality'? (Not necessarily product quality, but also service quality, internal efficiency, and others.)
- Have they taken the time to understand and plan the business processes and environment needed to achieve these outcomes?
In the course of a project, when trade-offs between project schedule, project and product cost, and product performance/conformance (e.g. 'quality') are discussed, does 'quality' usually come last in priority?

Conformance starts with:

getting the requirements right (what is the performance target that the product is conforming to?),
designing the product to conform to the requirements,
developing manufacturing/sourcing processes that minimize variation around the conformance target and that are stable over time,
putting into place procedural controls around the product design and the manufacturing processes to ensure that they do not drift, and that any changes are appropriately vetted and approved, and
a design that is robust to the remaining manufacturing variation and to variation in the distribution and use environments.

Some companies seem to have regressed to an early-1970's quality paradigm; inspect, inspect, inspect. Worse still, the inspections are focused on product, and not on auditing the business processes and systems that lead to the design and manufacturing outcomes.

There are some who seem interested in preventing issues and to create "closed-loop" systems so that we can learn from and prevent issues. But when it comes time to allocate resources in certain areas there is still reluctance from Top Management. Proactive, closed-loop quality takes effort and resources and requires an appropriate organizational structure, business processes, and commitment from top management.

What is a Quality System?

A Quality System (aka Quality Management System) is a set of inter-related Business Processes. The output of the Business Processes includes the product. The "quality" of the product is an outcome of the business processes (aka quality system).

The value of a Quality System can be thought of in this manner:

What is more efficient and effective: Chaos? Or a system of planned and understood processes?

If a company does not have Top Management commitment (section 5.1) and does not proactively plan and execute a System of Business Process (section 5.4.2), then the result is chaos, confusion, and inefficiency.

ISO 9001 (or equivalent) simply documents accumulated wisdom gained from collective experience as expectations for best practices in all aspects of the business that can affect "Quality" of product or service.

Businesses generally tend to take one of two paths:

Path A: They put minimum effort into implementation of the standard, preferring instead to construct a thin veneer that appears to the uninformed external observer to satisfy the standard but which is not effective.
Path B: They implement a system that is effective, and in a way that is consistent with the needs of the business, their customer's needs, and their industry.

Quality is of process of exploring and minimizing the gap between "should be" and "is".

A Quality System minimizes chaos and entropy.

Fuzzy requirements = Fuzzy 'quality'