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Originally from a domestic electronics and radio communications foundation, I spent ten years in the Oil, Gas and Nuclear industry in the fields of Hazard Assessment and Reliability specialising in software quality, hardware reliablity and availability maths modelling. I have published technical papers on the subject and have contributed to others. I have also been a member of the European Workshop on Industrial Computer Safety (EWICS) .

I have been in the Pharmaceutical Industry since 1994, was Managing Director of my own Limited Company for six years during which I worked exclusively in the pharmaceutical industry. The remainder of my resume, configured in present position first is as follows:

Simple CV

Software Quality Engineer at LifeScan (Scotland) a Johnson and Johnson Company  

February 2006 - Present (3 years 2 months) 
Quality Engineering Role associated with Software Development Lifecycle and best practice 
for software-embedded medical devices. 

Computer Systems Validation Specialist (Contract Role) at AstraZeneca 

2002 - 2005 (3 years) 
Liaison with IT infrastructure team., leading Quality role on high profile IT projects, 
review, influence and approval of lifecycle documentation and best practice. 

Computer Systems Validation Specialist (Permanent Role) at GlaxoSmithKline 

May 1999 - January 2003 (3 years 9 months) 
Site Computer Systems Inspection Readiness Representative - process mapping products from end to end, 
identifying computerised systems, performing gap analyses and managing their validation or revalidation. 
Computer and Controls System Validation Consultant at GlaxoWellcome 
Public Company ; GSK ; Pharmaceuticals industry 
November 1996 - May 1999 (2 years 7 months) 
As Managing Director of my own consultancy firm I supplied services that included managing competitive 
tender processes from a commercial perspective and controls engineering through to validation of 
regulated computerised processes used for the manufacture of drug product. 

Project Engineer at GlaxoWellcome  

September 1994 - November 1996 (2 years 3 months) 
Supplying consultancy services under my own limited company (GRD Project Services Litd), Managing 
several multidiscipline projects supporting Pharmaceutical Research Requirements responsible for 
budget, tender, contractor and contract management, engineering within own areas of expertise, 
validation and financial closure. Responsible for the design and implementation of site-wide 
lone worker alarm system to cover a 135 acre site including sub-ground level coverage. 

Validation Engineer at Eli Lilly 

1994 - 1994 (less than a year) 
Wrote computer system validation procedures 

Lead Reliability Engineer at Industrial Control Services plc (Now ICS Triplex)  

July 1984 - November 1993 (9 years 5 months) 
Identification of revealed and unrevealed failure modes at low
level (circuit) and establish the impact at system level.

Recommend maintenance test strategies based on known failure

Perform reliability and availability studies from system to component level for Energy 
Industries customers for onshore and offshore installations

Training - participation in Industry working Groups 
Senior Communications Technician. at London Communications (Equipment) Limited 
Telecommunications industry 
January 1982 - July 1984 (2 years 7 months) 
Fault finding, calibration and alignment of radio communications equipment.
Design of small specialised customisations for the above - British Transport Police, 
British Aerospace Security etc... 

What Have I learnt over the years?

The basis for the following is the consideration of a pragmatic and practical view of two opposing corporate scenarios. On one hand there is the oversimplification of 'statistics' that purports the success, or otherwise, of business processes that contribute to the making of important management decisions. On the other hand there is a frequent perception of overzealous application of costly and time consuming methods that are difficult to understand at the upper echelons of a company.

Somewhere in the middle of these two extremes lies a pragmatic and common sense way of working. In the construction industry, the analogy would be the difference between the widespread application of engineering tolerances to the construction of a housing estate. The opposite would be the widespread use of building industry tolerances in the implementation of a high risk high capital process installation.

Most large manufacturers strive to achieve a leaner and more cost-effective way of running their business in order to maximise profits and to deliver value for money to their customers. Many industries are also governed by strict regulations that are in force to protect employees and customers alike. This is especially so where hazardous processes drive a need for safety critical systems that protect personnel or customers.

Companies producing drug product must ensure that in the event of an unfortunate anomaly that results in damage or injury, they shall be able to prove in a court of law, that everything reasonably practicable was done to avert the disaster. As most readers know this phrase applies to all industries. Anything that affects strength, identity, security, purity or quality of a drug product shall meet current Good Manufacturing Practice (cGMP) as defined in the EEC 'Orange Guide' or the
FDA Code of Federal Regulations in the USA.

Quality standards in many industries are there to guide manufacturers and to provide customer confidence. In many industries strict adherence to quality standards is not mandatory. In the Pharmaceutical industry it is law. The simplest rule of cGMP is 'if you didn't sign and date it then it didn't happen and it is rumour'. So much for the ideal of the 'paperless society' you may think, but the recent legal acceptance of electronic signatures changes this - albeit that there are specific ways in which this must be achieved.

The Computer Validation Initiative Committee (CVIC) , a working group of the Society of Quality Assurance (SQA), provides current industry perspectives on Computer Validation Issues. They have good reference text available online including specific feedback from the FDA on Electronic Records and Electronic Signatures (ERES).

Whether by using a pen and paper, or by electronic means, a signature has legal standing such that signatories hold a legal responsibility for their actions. cGMP requirements, therefore, require appropriate documented experience and authorised training of personnel who apply their approval signature to cGMP documentation. Application of a signature means that they have read and understood the contents of the document they have approved.

A product that has 'inbuilt' quality must inherently have traceability from design to shipment. Traceability in the pharmaceutical industry is manifested in batch records. It does not stop there. Systems that are used in the process of drug product manufacture, archival and retention of records, procurement of critical items in contact with the product, identification, filling, packaging, labelling, patient information, and shipment are all subject to validation in their own right to ensure that the overall requirement of traceability is met. Another term for traceability is 'visibility of process'.

Systems used to achieve the above listed functions must therefore have 'visibility of design'. This means that when an audit is carried out on a system, its specification is expected to be detailed enough to ensure repeatability in the scientific sense and be approved by experienced and trained people. It shall also be understandable and approach the design process from a 'top down' perspective. Testing against these exacting specifications must also have been conducted in a similarly controlled (and credibly independent) way with a traceable link to the system that has undergone the testing.

The introduction of 'Total Quality' (TQ) philosophy or 'integration of quality' are concepts that are frequently 'sold' to industry. The financial benefits of devolving quality related activities to those performing the tasks are easily measurable by monitoring short term profits. The improper use of statistics that fail to consider the rate at which events occur rather than the instantaneous 'number of failures' contributes to ill advised decisions being made. In many hi-tech industries, about five years after implementation of a 'TQ programme', product quality and customer confidence drastically wanes as a result of lost learning experiences.

The reason for this is that human nature takes over and basic traceability - a factor intrinsic to quality - all but disappears under the illusion that quality is 'built-in'. In the pharmaceutical industry there are validation specialists who are there to prevent this from happening. Validation personnel are not only concerned with testing. They ensure that the whole entity can withstand scrutiny by ensuring that tangible evidence exists - pretty much in the same way that the legal profession prepares a case for a hearing. Other industries do not necessarily have quality personnel who have the same 'clout' or influence. Support industries to pharmaceutical companies have enormous difficulty in understanding these quality requirements - especially if it is not their core business interest.

There are many examples in industry where these principles have failed in this way - consider the number of household names that no longer exist. Many quality gurus predicted that the 'TQ' principle will not function in the western world because of cultural differences between it and Japan where the concepts originated. Some of this is obviously necessary to stay competitive. One should also not ignore the
sixty year business cycle, that oscillates between between Eastern and Western cultures. This only proves that you can modify human behaviour but it is difficult to totally change it.

Draconian 'hire and fire' 'X' management styles that vociferously shun the 'what is required for this to fail' views of the safety and quality professionals are on the increase due to international business interest in Europe. This goes against most European management training and results in unwanted politics and face-saving. The strongly promoted views in this environment are 'you do what is required to make it work' Coupled with the above principles, this will most likely mean that a new quality revolution will need to happen within the next ten years.

Realisation of the problem will arise from inevitable undesirable events and consequences. This is not supposition. Shareholders, Bankers and financiers, generally do not understand regulatory control and quality requirements over the industries they are involved with. Companies are often forced by them to make drastic decisions based on maintaining growth curves without consideration of the consequences of making cuts in the wrong areas. There are several serious events that have taken place recently that could be perceived as being attributable to this.

Value for money is indeed what quality is all about. In some industries quality means more than this because of the potential consequences of failure. The age old quality cost curve, when law suits and lack of customer confidence for critical products are considered in the equation, is still a very valid tool. It is unfortunate that it is all too often incorrectly used to reduce the investment in quality disciplines rather than ensuring that quality expertise exists to protect companies from themselves.

(c) Geoff R Duke - June 2001

No specific company is implied or referenced in the above text. The above represents a personal view based on experiences and conclusions drawn by the author and is thus not representative of any view held by any company, body or institution.

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