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
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:
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.