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This article will consider the concept of “quality” and looks at how a range of experts in this field have arrived at various quality definitions.

Note: This article is based on Chapter 2 of the first Unit of our QP Quality Management Systems course and can also be viewed as a video by clicking here.

John Ruskin, the Victorian art critic, suggested that “Quality is never an accident, it is always the result of intelligent effort”. In other words, “quality” doesn’t just happen – we have to work at it!

Across the Atlantic Ralph Waldo Emerson, the 19th Century American poet, essayist and philosopher proposed that a “quality product”, even if only a mousetrap, was something worth seeking out!Ralph Waldo Emerson

“If a man should paint a better picture, preach a better sermon or even build a better mousetrap, then even though he builds his house in the middle of a forest, people will make a path to his door”.

People will make a path to your door! And that is what an aspect of “quality” is about perhaps, getting people to make a path to your corporate door!

Ask any group of people what “quality” is and what it is about and you will get a myriad of answers. Quality is undoubtedly a moveable feast – and what is “quality” for one person is not necessarily “quality” to another.

Generally though, such answers will centre on well-rehearsed clichés such as “meeting specification” or “the right product, at the right time and at the right price”.

“Getting it right first time, every time” and “making goods which do not come back for customers who do” would also surface in any discussion.

We may even have definitions of quality thrown in – Dr Juran’s “Fitness for purpose” and Philip Crosby’s “Conformance to requirements”.

The important thing to note is that quality thinking has evolved over time.

Principles associated with business needsenvironmental needsdesign and development needscustomer needs (both internal and external), stakeholder needs and the operational needs of effectiveness and efficiency have all been “embraced” into contemporary quality-thought.

This evolution in quality thinking is perhaps best seen through the changes evident in quality-related definitions.

Both Juran and Crosby crystallised their thought processes, through their definitions in the 1970’s. The focus being very much on product quality, the product will be “fit for purpose”, the product will “conform to requirements”.

In the 1980’s WE Deming, our management guru, introduced a temporal aspect to our “quality thinking” suggesting that we should be concerned about “fitness for purpose” not only today but also in thinking about the future and future consumer needs “quality should be aimed at the needs of the consumer, present and future”.

Armand Feigenbaum, the Total Quality Control expert, suggested a much more embracing view of quality. He said that quality was “the total composite product and service characteristics of marketing, engineering, manufacture and maintenance through which the product and service in use will meet the expectation of the customer”. In including elements such as “marketing”, “engineering” and “maintenance” he was suggesting that we should not only consider the product quality, but also those elements that may impact on the achievement of product quality; such as “marketing” – in promising the earth but not delivering and “engineering and maintenance” – with down-times and equipment malfunctions.

ISO, the International Standards Organisation, in “ISO 9000:2005 – Fundamentals & Vocabulary”, defines quality as “the degree to which a set of characteristics fulfils requirements”.

Whilst at first ephemeral the definition allows scope for us to embrace a whole set of “characteristics” (such as achievement of product specification, delivery on time and in-full, achievement in an effective and efficient manner) and a range of “requirements” (such as those of internal and external customers, shareholders, society, employees and regulatory bodies).

As with Feigenbaum – a more embracing view of quality.


Driving this thought process forward have been saleability models that, whilst maintaining the pre-eminence of product quality, also highlight the importance of delivery and cost as “quality considerations”.  Whilst delivery and cost are important factors when choosing something, it is normally quality that has the sustained impact.

Other quality models have suggested that attention now needs to be paid to all quality parameters, not only conformance to specification, but also the quality of design andquality of use (that is the actual cost of ownership). In other words you can have a great product, but it’s no good if it breaks down shortly after use.

Additionally, attention now needs to be paid to all quality dimensions – not only product quality, but also business quality (including our environmental and ethical stance) and organisational quality (including our effective and efficient operation).

Such thinking has prompted us to view “quality” as a much more embracing concept and not something solely concerned with “product conformance”.

And so, in this introductory chapter we can see that quality is an evolving notion – it has evolved and continues to evolve. It has become a more embracing entity, more holistic as it embraces not just product quality, but also those elements/ factors that can impact on quality. The development in thought process has been evident, over time, in the various attempts made to define quality and is seen through the evolution of definitions.

Whilst many systems, and indeed, many standards, continue to focus on product conformance – and this element is core to quality – contemporary quality thinking suggests that this is not enough.

Attention now needs to be paid to all quality parameters and all quality dimensions – we ignore their potential impact on product conformance at our peril. We can be effective and be making product that wholly conforms one week, and if this is not achieved efficiently, be out of business the next week.

And in line with this evolution in quality thinking our thoughts regarding the constitution, role and workings of a Quality Management System have also evolved and we will look at this evolution in the next chapter – see earlier article.

Lots more articles on Quality Management Systems can be found on the QMS news page.

Note: This article is based on Chapter 2 of the first Unit of our QP Quality Management Systems course and can also be viewed as a video by clicking here.


Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

Our 2-day course is updated for Annex 1 changes

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