An Alternative Approach to Quality Pyramid (A Greener QMS?)

In 1987, ISO 9001 was released with an analogy of a pyramid often being used to represent the documentation requirements of the standard for Quality Management Systems (QMS). Quality Pyramid analogy is a very essential illustration that is commonly used in almost all Quality Management Systems (QMS). This is mentioned to help readers to be able visualize the hierarchy of documents and based on the suggestion that there are layers of documentation in every QMS.

Quality Pyramid

Mainly, it suggests that at the top of the pyramid there is a quality policy mentioned and as we go down the pyramid it opens up as different layers to first as set of procedures and then to more detail of explanatory documents to clarify day to day activities (work instructions) and finally at the very bottom as forms and records.

Although this is commonly accepted by the industries, one may also argue that it is counterintuitive. Let me explain. As well known by the experts, the main reason that there is a QMS in organization is that it provides document traceability and the relationship between the documents. This is not very well pictured in the quality pyramid. The alternative suggestion would be to illustrate the relationship between the documents as a tree model.

Quality Tree

The reason why this alternative approach is suggested is basically because of the fact that most of the quality documentation users see these documents as formalities even to the point where some of the very essential documents (i.e. Quality Manual) are is being overlooked.

I am a strong defender of the idea that nothing irrelevant should find its place in QMS, hence everything mentioned should be pertinent, connected and feeding the unity of the entire system: just like a tree!

The Roots (Company Policies, company objectives, related regulations and standards):

This group is the information that is gathered to create an overview about the company. Company Policies, Business Objectives, target markets, in-scope products, and related regulations and standards can all be placed in this category. From the beginning the quality experts should know these and use them to build the Quality Manual. Just like the body of a tree is the most important part, the Quality Manual acts as the most critical document and an overview of the entire system.

The Trunk (Quality Manual)

Quality Manual acts as a backbone of the entire system. It feeds itself from the root hence provides information about the above-mentioned documents and resources. It also has connection to the main branches which are the applicable set of procedures, in other words Standard Operating Procedures (SOP). In ISO standards (i.e. ISO 13485) for quality management systems some of the main chapters are listed as:

•  Management Responsibility,

• Resource Management (human resources, infrastructure, work environment and contamination control)

• Product Realization (design and development, purchasing, production and service provision, control and monitoring of measurement equipment)

• Measurement Analysis (monitoring and measurement, control of nonconforming product, analysis of data)

When applicable, all these chapters should find their places in the quality manual as main set of procedures.

Limbs (SOP’s):

Standard Operating Procedures are the documents specific to a function area. These are high level documents that not only refers to related standards but also to the smaller branches (Work Instructions).

Branches (Work Instructions)

Every procedure, requires several work instructions to be able to complete the task. Work instructions describe the detailed work to be done and the generated evidence usually is kept in the form of a record or a form.

Twig (Forms / Records)

Just like tree loses its leaves and grows new leaves continuously, evidence captured from the work on daily operation must be saved in forms and records. These records are to be kept safely according to the retention policy of the organization.

Practical Examples to support the Analogy:

1.      When a new product or service is added to the portfolio, the QMS update should start from the roots. In other words, the related standards are to be considered, Quality Manual is to be updated accordingly, impacted SOP’s are to be considered and the related set or Work Instructions and forms are to be created. We do not make any update starting from the limbs or branches.

2.      The same logic applies when there is a scope reduction. This should start from the roots. By doing this, all the related elements in the QMS can be considered and the excluded from the system fiber by fiber.

3.      Everything is connected in a QMS, no document stands by itself. By this way, when a change is required, it is easier to estimate the impact.

4.      Nothing that does not support the ecosystem in a tree is kept in the system. If a standard or a regulation does not have a use in a QMS, it should be excluded from the entire system. Only relevant information should be mentioned.