Less is more | Joe Hagan-Brown

Quality Management Systems are often structured in a predictable manner which involves the creation of a hierarchy of documents. Often this system can be document heavy and inefficient. Typically a QMS will include the following types of documents and records:

  • Quality Manual

  • Quality Policy

  • Quality objectives

  • Quality procedures/Work instruction

  • Quality records

There can be many procedures, forms records etc which are created to meet the specific needs of an organisation. Often in order to keep track of everything, The Document and record control procedure makes use of a Document control register or some other log or record which lists / indexes all of the Quality documents which make up the QMS.

One area I often see a lot of duplication in when auditing Quality management systems, is in the area of Quality records and forms. Often organisations have e.g:

  •  a complaint form,

  • a CAPA form,

  • a product non-conformance form

  • Customer feedback form

  • PMS submission form

  • Vigilance reporting form

  • Change control form

These are just a few examples. A careful reading of ISO 13485:2016 and the relevant clauses of the standard relating to some of the process areas associated with the types of form/record above, will reveal to the reader that the standard does require certain records to be defined (it clearly states this in multiple places throughout the standard). However nowhere in ISO 13485:2016 does it indicate that e.g. the complaint form has to be separate from the CAPA form. Likewise the customer feedback form does not have to be separate from the complaint form.

Why can't we have one quality record which fulfils the need for a complaint record, but which also can accommodate a CAPA, or a product non-conformance. Or maybe all three?

What stops us from using the same form to record PMS, as well as customer feedback?

Can we not reduce the quality and regulatory burden on our most valuable resource (our people), by converging records into fewer documents?

In my experience, the only thing stopping us in most cases, are the limitations we self impose on how we interpret the requirements of the standard.

Do you really need to create yet another new form, or quality record template?

Less is more.

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