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Good Manufacturing Practice — You can’t manage without it! (Paper given at the lFST Annual Conference, 15 October 1998) J Ralph Blanchfield
Food and drink industry managers, food scientists and technologists have long recognised the special responsibilities of the food and drink industries to make available products of maximum value and desirability to their customers and consumers. To achieve this end the food or drink manufacturer has to ensure that the manufacturing process delivers a product that is uniform in quality, free from defects and contamination, and as safe as it is humanly possible to make it. GMP requires, therefore, that there is full and detailed specification of the product and of everything that goes into making it, and management of resources, measures and precautions to ensure that the Specification requirements are fulfilled. It is evident that GMP has two complementary, and interacting components; the manufacturing operations themselves, and the HACCP-based quality control / quality assurance system which IFST has designated "food control". Both of these components must be well designed and effectively implemented. The same complementary nature and interaction must apply to the respective managements of these two functions, with the authority and responsibilities of each clearly defined, agreed and mutually recognised. This is not to ignore or belittle the importance of other key functions essential to the well being and progress of a company, or indeed of those other functions contributing direct services or advice to the manufacturing function. So who needs GMP? First, company chairmen, presidents, chief executives. No, they are not directly concerned in designing or implementing GMP, but it is they who are responsible for establishing GMP policies and for providing authority, facilities and resources to the functional managers and staff. Apart from that, who needs it? Every kind of manager in industry. Here is a list (Table 1) and I dare say we could add to it — but note the ones at the bottom. Those involved in legislation and enforcement need to be GMP-literate, and likewise those responsible for teaching the next generation of all those managerial functions. Academics cannot take the line "GMP is for industry and does not concern academia." Effective Manufacturing Operations Every aspect of the manufacturing operation, including all resources and facilities, must be properly specified including critical control points, premises and space, equipment, trained people, raw materials, packaging materials, storage, transport, operating procedures, cleaning procedures, management and supervision, and services (see Table 2). And, critically important, these must be provided in the right quantities, at the right times and places, and MUST BE USED. To ensure that manufacturing operations DO go according to plan it is essential that • the relevant written procedures are provided to operators, in instructional form and in clear and unambiguous language, and are specifically applicable to the facilities provided; • operators are trained to carry out the procedures correctly; • records are made (whether manually or by recording instruments or both) during all stages of manufacture, which demonstrate that all the steps required by the defined procedures were in fact carried out, and that the quantity and quality produced were those expected; • (records are made and retained in legible and accessible form which enable the history of the manufacture and distribution of a batch to be traced; • a system is available to recall from sale or supply any batch of product, if that should become necessary.
Effective Food Control The other and complementary major component of GMP is effective food control. Effectiveness requires • well-qualified and appropriately experienced food control management participating in the drawing up of specifications; • adequate staff and facilities to do all the relevant monitoring of suppliers, inspection, sampling and testing of materials, and monitoring of process conditions and relevant aspects of the production environment (including all aspects of hygiene); • rapid feedback of information (accompanied where necessary by advice) to manufacturing personnel, thereby enabling prompt adjustment or corrective action to be taken, and enabling processed material either to be passed as fit for further processing or for sale as the case may be, or to be segregated for decision as to appropriate treatment or disposal. Licensing? Both the design of the manufacturing operations and the operation of the food control function need to be based on scientific and technological knowledge. Every food business needs at least someone with that sort of know-how and expertise. Even the smallest of food businesses needs food safety know-how appropriate to the nature and activities of the business, but many small and even medium businesses do not have it. That is the real reason for licensing and the reason why IFST has long advocated it. It is not a substitute for GMP; but if the licence is conditional not only on the satisfactory hygiene of the premises, equipment and operations but also on there being a responsible person with demonstrated food safety know-how in even the smallest food business, it forces many that are well below standard to shape up or get out. I well remember being involved, in 1990, when the Food Safety Bill was going through Parliament, and saying "You would not allow a small delivery business to operate with an unroadworthy van and a driver without a driving licence. Why allow the potential equivalent (with equally lethal potential consequences) in a small food business?" At the time I also said "If conditional licensing meant that some small food businesses would not be permitted to operate, so be it - a food business that is incapable of providing safe food ought not to be in that business"; and (sadly prophetic words?) "In the event of a serious food poisoning outbreak, it would be of little consolation to the bereaved of those who died, and to those made seriously ill, to be told ‘Ah, but it was only a small business’ ". I recall too, John Gummer ridiculing the idea, as he put it, that "the lady providing cups of tea in her tea-rooms needed a PhD". But she will also be handling cream cakes and sandwiches, and needs to have sufficient food safety know-how to do so safely. IFST’s GMP Guide 4th Edition It is easier to state the goals of GMP than to achieve them. For over a decade, the IFST GMP Guide in three successive Editions, has been the comprehensive "bible" that has set out the means by which GMP goals are achievable; and has been widely and effectively used to that end in the food and drink industries. The 3rd Edition, published in 1991, served its purpose well, and continued to receive international acclaim right up to the time when its successor was published. The basic principles of GMP do not change, but science and technology develop and the context in which GMP principles are applied does change. Since publication of the 3rd Edition there have been important developments, in food science and technology, in the intensity of public interest and concern over food safety, and in legislation. Of major significance has been the incorporation of Hazard Analysis Critical Control Point (HACCP) principles into obligatory legal requirements. It is inevitable that legislative references in this Guide concentrate on Europe and the UK; but the principles outlined are of general application and may be interpreted and applied in any country in terms of its own legislation. For the new 4th Edition (Blanchfield, 1998) the whole guide has been reviewed, revised and rewritten. Particular attention has been paid to updating the legislative information, to expanding greatly the HACCP material and to showing the interrelationships of HACCP, effective manufacturing operations, quality assurance and quality control, integrated into GMP. Increasing interest in novel foods and processes and increased recognition of food allergens as an important food safety issue, have prompted the inclusion of two new chapters on those topics. The new 4th Edition is a necessity to all in a managerial or technical capacity concerned with the manufacture, storage and distribution of food and drink. It will also be a valuable reference for food education, for training and for those involved in food safety and enforcement. What – No "Food Hygiene"? Those unfamiliar with the previous three editions may look through the 32 chapter titles and be astounded to find none entitled "Food Hygiene". That is intentional. GMP does not involve putting food hygiene in a self-contained "watertight compartment" but, on the contrary, treating it as an integral part of every aspect , a theme running through the whole subject and the whole Guide. Jeff Rooker, in his Ministerial Foreword to the GMP Guide 4th Edition, referred to the vital importance of food safety and went on "Consequently it is entirely appropriate that the professional organisation for those at the sharp end of food production should devote its resources to the development of guidance on good manufacturing practice, and I welcome the publication of the fourth edition of this IFST Guide." "for those at the sharp end of production" is relevant in the limited context, of the Foreword, but I am sure that MAFF Ministers and officials appreciate, and I hope that non-members of IFST present at this Conference will appreciate, that IFST is not limited to "those at the sharp end of production" but is the professional body for professionals in every aspect of food science and technology and in every relevant location; not only in industry but in academia, research, enforcement and even in Government departments! Production of the GMP Guide is only one of its many activities. Jeff Rooker continued "Although not Government guidance, it is wide ranging and comprehensive in scope, and aims to be applicable to all sectors of the food and drink industry. I am confident that it will continue to make a positive contribution to the setting of high food safety standards throughout the industry as a whole" It is right in the context that the Minister concentrates on the food safety aspect of GMP – but GMP consists of ensuring food safety – and a lot more. "Although not Government guidance ...? I would contend that because of the inputs to successive editions by many people and organisations, including many of those "at the sharp end", it is based, like its predecessor editions, on a collective knowledge, experience – and dare I add wisdom? – well beyond what any single company could acquire for itself, and is better than Government guidance. But then I would say that, wouldn’t I? As Editor of, and one of the contributors to, the GMP Guide. I am bound to be prejudiced in its favour, aren’t I? Well, we have received many favourable independent reactions from leaders in manufacturing, retailing and the world of food science. I’m sure the others will forgive me if I end with just a couple of quotes from industry leaders and one from an independent book review –
"The IFST’s Good Manufacturing Practice Guide has become, since its first edition in 1987, an indispensable document for any food or drink manufacturing organisation. The Guide does not endeavour to answer all questions – it is not its purpose – but it does challenge all concerned to ensure that those who are charged with executing on ‘Good Manufacturing Practice" do so in not only a logical manner, but also an effective one ensuring the production of products which are not only safe, but can meet consumers’ requirements as to price, quality and service."
"I welcome publication of the fourth edition as an important contribution to raising standards of manufacturing management and practice in our industry. This is a practical guide to industry best practice relevant to all sizes of operation".
"This guide is all meat with very little fat and no gristle and this means that you have plenty of good material for you to chew on and digest! If you are involved in food production this guide should be at the top of your budget for 1999." International Food Hygiene, Vol 9 No 4 (1998) -- Extract from commendatory book review of GMP 4th Edition
To sum up – what GMP is about is responsible management, knowledgeably applied. Reference Blanchfield, J.R., Ed. (1998) Food and Drink – Good Manufacturing Practice: A Guide to its Responsible Management. IFST. TABLE 1 Who needs GMP?
and
TABLE 2 Effective manufacturing operations Every aspect of manufacture fully specified in advance; all resources and facilities specified, namely:
and
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