In this article we examine some general systems thinking points and consider the structure of a Quality Management System together with the underlying concept of Quality Management principles – the “oil” used to maintain our Quality Management System.
Note: This article is based on Chapter 3 of the first Unit of our QP Quality Management Systems course and can also be viewed as a video – see below.
For those of you that prefer reading to looking at a video the text below covers the points made in the video :
Systems are good things!
They give rigour, regulation and consistency to what we do. They are an ever-present facet of our lives. They give a focus to activity, they give format to otherwise dis-organised chaos!
Yes, systems are good things! We have our parliamentary system, our railway system, our motorway system, our education system, our health system – systems are everywhere.
One man, Antoine de Saint-Exupery, put a particular system under the microscope in 1942 – the French Military system, and in doing so suggested that systems might, indeed, not be all that they could be!
In his book “Flight to Arras” Antoine, a Free-French pilot during the Second World War, described the system that he found himself in, to such effect that he found his book banned by the authorities! He maintained that:
“We are living in the eyeless belly of an administrative system. The system is a machine. The more perfect the machine becomes, the more it can eliminate the arbitrary human element. In a perfect system where men are cog-wheels, laziness and dishonesty and injustice can no longer hold sway. But just as the machine is built to ensure a sequence of absolutely pre-ordained actions, so it cannot create. It administers. It applies the right penalty to any error, the right solution to any problem. The system is not designed to resolve unexpected challenges. If you introduced pieces of wood into a steel press, furniture would not come out at the other end. For the machine to be adapted to the purpose, a man would have to have the right to pull it apart … but in a system designed to rule out the disadvantages of the arbitrary human element, the cogs will not accept human intervention. They reject the watchmaker”.
Antoine was describing here a system that was vindictive, brutish, malevolent – sound systems should be capable of creating and not simply administer. Sound systems should be designed to resolve unexpected challenges and of course we ignore the arbitrary human element (in other words “us”) at our peril.
As an integral part of a system, as a user of a system, as someone dependant on the system you have the right, the duty, to pull it apart – because you are the watchmaker!
Tom Peters, our management guru, was less philosophical and argued; “The trouble is, companies have either lots of passion but no systems, or too many systems and no passion”.
A generalisation no doubt but there is no doubting that we need both a system, a system that is not vindictive, or brutish, or malevolent, as was Antoine’s and we need passion within that system, passion that may be gained by not ignoring the arbitrary human element.
And so, in thinking about questions that we may ask of our Quality Management System; we need to ask “how effective is my system?” We need a system which will ensure compliance, which will ensure “fitness for purpose”.
We also need to ask “how embracing is my system?” Does it embrace more than “product conformance”? Does it embrace the notions of an embracing system seen through our evolving definitions in the previous chapter? Does it embrace all stakeholder needs?
We should also ensure that we do not exclude the “arbitrary human element” and ask “how passionate is my system?”
And finally, perhaps most importantly, we should ask “am I an effective watchmaker?”
What is a Quality Management System?
Having looked at some general aspects related to systems thinking we would now do well to try and define what a Quality Management System actually is. In doing so we can turn to the International Standards Organisation based in Geneva, Switzerland and a document known as ISO 9000 Quality Management Systems – Fundamentals and Vocabulary.
So, what is a Quality Management System? The internationally accepted definition is that it is “a management system to direct and control an organisation with regard to quality”.
What then is a Management System?
A Management System is “a system to establish policy and objectives and to achieve those objectives”.
Three elements of note fall out from this definition – policy, objectives and achieve.
And so we can begin to build our Quality Management System model comprising our Quality Policy and our Quality Objectives. But how do we achieve our policies, our objectives? Achievement?
To achieve our policies and our objectives we exercise, we employ “Quality Management” – “co-ordinated activities to direct and control an organisation with regard to quality”.
Through the deployment and implementation of these co-ordinated activities that direct and control us, we are working towards the achievement of our policies and objectives.
Just dwell a moment and think about the types of co-ordinated activities that you would employ within your own organisation.
A whole raft of co-ordinated activities may be employed so that we achieve our policies and our objectives; training, inspection, internal audit, equipment maintenance programmes, documentation control, planning and logistics, purchasing, product and system review and calibration are all examples of co-ordinated activities we may employ.
What about our Quality Policy?
The Quality Policy sets out the “overall intentions and direction of an organisation related to quality as formally expressed by top management”.
A document to give focus to our efforts, a sense of purpose, a quantifiable statement of intent rather than an ephemeral wish list.
And our Quality Objectives?
Defined as “something sought, or aimed at, related to quality”.
And so, our Quality Management System model begins to look like this …
With our co-ordinated activities grouped into one of 4 major areas – Quality Planning activities, Quality Improvement activities, Quality Assurance activities and Quality Control activities.
When I look at this model I see a car engine. The cylinders, the pumps, the ignition elements, the valves, the wires, the carburettor, but something is missing!
Management Principles – the oil
We may have the best engine block in the world but we need oil to make it function effectively and efficiently, to make it purr, to make the elements interact smoothly. In order to achieve this we need to “pour in” certain Management Principles. This will provide the oil to the engine block.
In order to make our engine block function effectively and efficiently we need to maintain a customer focus – recognising both our internal and external customers. We need to exercise leadership – at all levels and throughout the organisation. We need to involve our people and engage them and we need to maintain mutually beneficial supplier relationships. We want longevity of consistent and reliable supplier inputs. All giving passion to the “engine block”, all engaging the “arbitrary human element”.
Let’s pour in some more oil !!
We need to adopt a factual approach to our decision making process – decisions based on on-going monitoring. We need to make continual improvement a permanent objective – both organisationally and at an individual process level. We need to take a systematic approach and integrate our different systems – not keep re-inventing the wheel and duplicating effort and, finally, we should adopt a process approach to our operation, thus ensuring efficient operation between our different organisational processes.
In combination we have then ….
Our Management Principles – designed to be used and deployed by Top Management in order to lead the organisation towards effective, efficient and improved performance.
And when integrated with our “Engine Block” we have …
A final structure
Where we see the “Engine Block” combined with the “Oil”.
A final structure that gives us the Foundation for a system through which we may monitor the effectiveness of our operations, a structure that can be embracing and implemented in all organisational areas that may impact on Product Quality and a structure that embraces the human element, through our Management Principles, and so is Passionate.
It gives us a structure, a system, that can be seen and replicated at all levels. An organisational system maintained by Top Management, a departmental or process-based system maintained by Departmental Heads or Process Owners.
In this article we have looked at some thoughts on systems and whilst a sound concept Antoine showed us that systems can be narrow, lack passion, be ineffective and inflexible and ignore the “arbitrary human element”.
We have, through International Standards definitions, defined a structure for a Quality Management System model and seen the elements that make up the engine block. We have suggested that this is a multi-dimensional model that can be seen at all levels in the organisation. And finally we have identified and established the role of certain Quality Management Principles – these providing the “oil” to our “engine block” and ensuring its smooth running, principles that may be used by Top Management to promote the effective, efficient operation of the system and to provide a catalyst for continual improvement.
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 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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