Senior management leadership and commitment of personnel at all levels (in other words, the organisation’s ‘quality culture’) are the foundation of measures that ensure product quality and continuity of supply. Although described in current guidance such as GMP Chapter 1 and ICH Q10, the importance of quality culture has been recognised for nearly half a century.
In 1972, a failure to sterilise a batch of intravenous fluid led to a public health emergency in the UK – often referred to as the ‘Devonport Incident’. The defective medicines were linked to fatalities and the Department of Health initiated what it called a ‘life or death’ search for unused product in the distribution network.
In the days following the incident the Government commissioned C M Clothier to lead an inquiry into the circumstances leading to the use of the contaminated fluids. It was a pivotal investigation in UK medicines history, which continues to influence international GMP requirements 47 years later.
The findings in the Clothier report were wide-ranging, but several are of relevance to quality culture in 2019:
- “There was no imminent technological advance in the field of production of intravenous fluids which will eliminate the need for skillful people devoted to their work”
- there was “a belief that sterilisation of fluids is easily achieved with simple plant operated by people of little skill under a minimum of supervision, a view of the task which is wrong in every respect”
- “Public safety ….. depends ultimately on untiring vigilance both in industry and by government”
The warning was clear: regulations, GMP and inspections alone could not guarantee prevention of similar disasters. Sadly, there have been other examples globally since the 1970s.
Despite long-term awareness of its importance, it remains difficult to define and measure ‘quality culture’. MHRA inspectors look for indicators showing that personnel at all levels of the organisation have appropriate technical knowledge to enable good decision-making and understand how their actions impact the product and patient.
A strong quality culture is built upon:
- knowledge of what is important, and how a process achieves critical quality attributes
- diligence, by fostering awareness that everyone contributes to product quality, and understanding that “my actions impact the patient and the company”
- vigilance by individuals who know what ‘right’ and ‘wrong’ look like in their process, and a mechanism for management to be aware of problems
- senior management commitment to being visible and transparent in decision-making so that positive outcomes can be seen from the diligence and vigilance efforts. This is more than the company mission statement – it’s ‘walking the talk’.
Pharmaceuticals utilise an increasingly global manufacturing supply chain. Common approaches to organisational behaviour may not always be effective due to societal considerations and there are many different influences on quality culture. We should be prepared to accept that an effective quality culture in one region may look different to that in another.
By being sensitive to the influence of global culture on organisational behaviour, we gain insight into the effectiveness of the ‘vigilance’ part of the quality culture, which can influence the selection of metrics. What matters is that the desired outcomes are achieved.
Quality culture – facilitating desired behaviours
Enabling a good quality culture requires continued effort from leadership and empowerment at all levels of the organisation. It is facilitated by clear communication of priorities:
- to personnel, helping them to understand the importance of their work
- to shareholders, to avoid unrealistic productivity pressures and explain the business and reputational benefits that a positive quality culture can realise
- to supply chain partners, making clear the information and resource requirements required for a consistent supply of high quality product
Communicating priorities to regulators can also influence the company’s risk profile, and for organisations who consistently demonstrate good quality-focused decision-making, the possibility of achieving regulatory relief as a result.
Back to 1972 ...
In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.
Technology in 2019 continues to progress at an incredible pace in new product development and novel manufacturing, analytical and supply chain practices. Some of these may require new regulatory approaches, which I will describe in a future blog post.
Despite significant progress in automation, there is still no replacement for a skilled and dedicated workforce who understand the importance of their work. Industry and regulators must maintain the highest levels of quality culture vigilance. I wish you success with these efforts as we go forward in 2019.
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