A quality management system (QMS) should describe how an organisation conducts business and manages quality in the fullest
sense. Although this is a very simple concept, many small organisations fail to grasp it and tie themselves in knots trying
to run their business in one manner while their QMS is set up to run the business in another. This results in an organisation
that is not correctly aligned, and the tensions between the QMS and the business then cause conflicts, inefficiencies and
risks that, if not addressed, can endanger the future of the business. To describe this as a headache is certainly a severe
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Many small organisations do not understand what a QMS should be designed to do and, as a result, they struggle to operate
the system in an effective and efficient manner, and within regulatory standards. More importantly, they fail to gain the
true benefits from a business perspective.
So, why do many small organisations not adopt a QMS wholeheartedly and, hence, fail to realise the benefits? One of the primary
reasons is that such organisations do not have a clear idea of how to develop and set up a QMS. Additionally, being typically
R&D-lead organisations, they do not usually have the expertise or the culture to drive QMS introduction. These factors can
cause organisations to make the wrong decisions on how to develop and introduce a QMS. Subsequently, when the QMS does not
meet expectations, the QMS itself is blamed, and the chances of convincing the management team to go back and re-deploy a
new QMS are slim.
A 'simple' QMS
Documents within the QMS need to effectively describe the key processes being used by the organisation, but this should be
done in a non-bureaucratic manner — the application of common sense goes a long way to ensure that documents and associated
systems are well-designed and effective in their application. It is recommended that the organisation develops a hierarchy
of documents starting with policies at the top, which then establish the necessary procedures within the QMS. There also needs
to be a solid and disciplined approach to prevent the number of documents increasing as the business develops. Some additional
documents may be necessary, but these need to be carefully considered to prevent the QMS from becoming unwieldy and disorganised.
QMS development should be accompanied by a proactive training strategy and the organisation will also need to consider whether
there is a need for a cultural change (the time taken to do this should not be underestimated). The key to a successful QMS
is the people who operate it; hence, culture, training and organisational structure must embody the best approach to gaining
people's engagement and alignment to the business strategy.
QMS key strategic elements
The introduction of an effective and efficient QMS requires the backing of the organisation's entire management team; otherwise
the system will not be aligned to the core aims of the business.
ICH Q10, which has been accepted globally by regulators as the best top-level design for a QMS in the pharmaceutical/biopharmaceutical
sectors, provides an excellent description of the responsibilities of the management team in the QMS:
- management commitment: ensuring the QMS is effective and achieves the quality objectives
- definition of the quality policy: describing the quality strategy which will, of course, include regulatory compliance
- oversee quality planning: defining and communicating the quality objectives; ensuring resources are in place; establishing
and reviewing of performance indicators
- resource management for all types of resources and their appropriate application
- internal communication in a timely manner, appropriately done, and in the correct flow, including clearly defined escalation
- management review — in other words, governance for suitability and effectiveness; assessment of periodic reviews of the QMS
- management of outsourced activities as necessary and purchased materials.
If these elements are built into the QMS from the start, it will allow a business to fully alight all strategies embodied
in the QMS, which will allow the organisation to meet the three main objectives of having a QMS — compliance, risk management
and productivity. The management team also needs to consider how best to ensure that the QMS is embedded within the organisation,
and how the quality function should be organised and deployed to ensure the QMS remains effective and compliant. It is essential
that the management team truly own the QMS and does not merely speak about its objectives and aims, while leaving the work
and worry to the quality manager and/or their team.