Acknowledgments
The opportunity for this book came from an invitation to write something for Business Expert Press. The, somewhat pretentious, title I offered was changed to this wider scope and gave me the opportunity to share the experience and understandings from a varied career.
After starting in Aluminium Chemicals research, I moved into technical paper-making with Wiggins Teape, which was then owned by BAT (formerly British American Tobacco) and is now Arjo Wiggins Appleton. I started at Glory Mill near High Wycombe in Buckinghamshire and the graduate intake scheme I was fortunate to join introduced me to their very mature leading-edge approach to quality management. Experience at Stoneywood Mill in Aberdeen and then the paper-converting operation at Dyce as a quality manager provided a base in the best practice in quality assurance and quality control well before there were international standards to support it. My mentor throughout those years and for a number afterward was Peter Daisley, and I would like to acknowledge that deep debt of gratitude for all his support and particularly the direction to the statistical disciplines that are such an important part of quality.
Dental Chemicals, with the very wide range of materials science involved, and testing laboratory supervision introduced me to Pharmaceuticals and the Orange Guide as some of the chemicals claimed therapeutic benefits.
This was followed by quality management in a medical devices company making single-use sterile and reusable Class II anesthetic and sterile single-use class III blood circulation devices and device sets. This also involved regulatory responsibilities setting up registration and all the device forms with the U.S. FDA and hosting one of the early Good Manufacturing Practice inspections in the UK. The quality management systems developed used local access to computer bureaux for the documentation. The work also involved national and some international standards experience.
In both experiences I was deeply indebted to the very able and experienced team members and have many happy memories of the individuals.
The next steps involved training in use of the emerging business microcomputers and software to develop quality management system, and this interest has been a constant theme beginning with the help of Roger Chambers in Aberdeen, who worked in the NHS on the IT side and is now a long-term family friend and fellow believer.
Quality management in computer and software manufacturing brought invaluable experience in this area followed by the first exposure to quality consultancy using the new, at the time, UK government grant scheme for development of basic quality management systems (QMS) but also included development of QMS software for gauge control and hospital ward management.
Contacts made in the time with Wiggins Teape resulted in a move into pre-clinical trial testing of chemicals and pharmaceutical testing with responsibilities in training and quality improvement. The experience of developing trainers and resources, and then delivering the programs, was a rich development time and contact with the four key original directors of the organization and the key QA and human resources staff a great joy. I am deeply indebted to Geoff Cox of new directions for all the vital input to our quality and management training in the pre-clinical chemicals and pharmaceuticals organization and particularly for the pointer to the work of Roger Harrison that forms such a key foundation of the later chapters of this work.
Experience of independent auditing for the UK Competent body for Medical Devices just prior to the passing of the first EU Medical Devices legislation was accompanied by a large team project work on the establishment of an early ISO 9000 QMS preparatory to the floatation of a major Scottish government building management organization and also experience in delivery of auditor training for the major UK standards and quality training and consultancy body.
Working in ISO 9000 and then TQM Quality Consultancy for the Renault Institute of Quality Management was founded on very well-developed training materials, which were a joy to deliver. This work also included IT support network creation and support for the team of consultants in the days when ISDN was the preferred, and the only really feasible, option for wide area networks for staff teams.
Recent years have seen specialization in test laboratory and calibration systems in the Marine Energy Renewables sector, long-term indwelling sterile Class III Medical Device specification and prequalification with major international agencies, authorized representative role with the same medical device, inspection body, and Innovative Environment Technology Verification (ETV) assessment, and work as an EU expert arising from this, quite apart from keeping the professional competence up to date in ISO 9001 certification.
The support from John Griffiths and the whole team at EMEC, including Lesley Bews, Chris White, and Neil Kermode, and those that I have worked there over the years has been key over the past decade and more, along with the EU ETV colleagues arising from this association.
The very rewarding long-term association with EMEC sprang from a membership of the UK Chartered Quality Institute (CQI), which was then the Institute for Quality Assurance (IQA). The consultants register for this body led to long-term associations with Ian Dalling, John Jeffery, and Roger Horne and others, and many opportunities for enjoyably widening, deepening, and maintaining quality management competences.
The understanding, support, and learning from Dr Bill Potter of Stapleford Scientific Services, and John Hurll of Hurll Technical Services have been rich friendships and have been invaluable in many important connections and particularly the statistical and scientific dimensions and connections.
Andy Taylor worked with me on eLearning and with his authoring of training material and with the science and quality background, his encouragement on reading the first draft was crucial. The help from my daughter Fenella Hayes throughout and in preparing the document for copy editing was greatly appreciated.
But without the long-term support of my wife Maureen and family, of which two of my three children have worked with me in my business for differing times before moving into their own careers, none of this would have happened. And we are both so grateful for the overarching care and leading that we both depend on in life.