Senior healthcare managers

As Chapter 17 (Kirwan and Shorrock) demonstrates, there is a huge amount that could be learnt from other safety industries and sectors. Some of the methods which have been tried and tested within the nuclear and oil and gas sectors are only just starting to be applied within healthcare (e.g. safety cases and human reliability assessment - Health Foundation 2012). Others such as the concept of safety intelhgence (discussed in Chapter 17 Fruhen et al. 2014) offer the potential for future work, particularly as it relates to senior managers within healthcare. Even a cursory glance at the accounts and recollections of well-known researchers in... 

Simply monitoring quality performance is just not adequate. The effectiveness of quality management systems should be actively managed and performance improvement opportunities seized. Business benefits should more than compensate for any investment in quality. Senior management, system owners, project managers, and anyone else involved with computer projects need to appreciate this. This book will help explain what needs to be done to successfully achieve quality and compliance of computer systems in the pharmaceutical and healthcare industries. 

Pharmaceutical and healthcare companies should appoint a senior management representative with specific responsibility for ensuring that the requirements of GxP are implemented and maintained. This individual, who often takes the job title of Computer Validation Director, must wholeheartedly champion the cause of GxP. The authority and responsibility of this senior position should be clearly dehned and recorded. 

Computer validation should not be undertaken unless fundamental validation controls have been fully understood and implemented within the pharmaceutical or healthcare company s organization. Here we allude to properly qualified personnel, effective document management and change control systems, internal audit procedures, methods of managing the deviations from standard practice thereby exposed, and a culture of continuous improvement (see Chapter 4 for more details). Senior management must not fall into the trap of assuming through complacency or idleness that these controls have been fully instituted In most firms there is usually much that still needs to be done in these areas. Let us examine these controls a little more closely. 

In such extreme situations justihcations for releasing pharmaceutical and healthcare products to market under these most exceptional conditions must be fully documented by responsible personnel, approved by senior management, and agreed in advance with relevant regulatory authorities. 

The first review level is necessary to confirm the inspector s understanding of the criticality of computer systems and set the inspection priorities. This will involve discussions with the pharmaceutical and healthcare company s senior technical management and a tour of the facihty. 

When a request to conduct an inspection is received, the pharmaceutical or healthcare company s senior management should be immediately notified. Notice of an inspection may be received by a number of people in a pharmaceutical or healthcare company, so it is important that a procedure exists describing how and to whom the request is passed onto. Usually the focal point is the Head of Quality. 

It is important that the inspection findings be presented to senior management in an honest, direct, and timely fashion. It may be many weeks, even months, before the inspector officially presents inspection findings back to the pharmaceutical or healthcare company. This is too long to wait to keep senior management informed of the implications of the inspection. 

Level 1 and Level 2 assessment outcomes usually denote pharmaceutical and healthcare companies whose senior management are still not committed to the implementation of validation and rely on their subordinates to enact validation without the practical support they could offer. Computer validation is often characterized by firefighting. 

As the new product lines came on-stream, Lilly s top management decided to sell off its non-healthcare business. Not only were the profit margins lower, but, as one senior executive stressed, they demanded a disproportionate amount of management time. In 1988 Lilly sold its Elizabeth Arden Cosmetics to Faberge for 700 million. The following year its agricultural chemical business was turned over to a joint venture, DowBlcano, in which Lilly held 40 percent of the equity and Dow Chemical the rest (see Chapter 3). By 1991 Eli Lilly had 78 percent of its sales in pharmaceuticals (9... 

A sample of 475 staff from 10 hospitals in Costa Rica, Gimeno et al. (2005) found that safety culture was related to self-reported work-related injuries. Another study of 789 hospital-based healthcare workers in the USA, found that experienced blood and body fluid exposure incidents for workers were lower when senior management support, safety feedback and training were perceived favourably (Gershon et al. 2000). In Japan, reduced needle-stick and sharp injuries to hospital workers were associated with safety culture factors, such as being involved in health and safety matters (Smith et al. 2010). In our Scottish hospital sample, we collected information on self-reports of worker injuries, as well as observed errors affecting patients. 

Elina Pietikfiinen works as senior research scientist at the VTT Technical Research Centre in Finland. Her background is in psychology. Her research interests include safety culture evaluation and development, safety management, safety expertise, organisational evaluation and organisational learning. She works in research and development projects in several safety critical industries, such as social and healthcare and the nuclear industry. 

Annemie Vlayen has a background in rehabilitation sciences and healthcare and hospital management. She is a senior researcher in patient safety at Hasselt University, Belgium. In her PhD research she focused on medical record review, prospective risk analysis and safety culture in hospitals. Her research interests include approaches to improving safety culture, leadership and patient safety education. 

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