Principle

There should be a comprehensive quality management system (QMS), so designed, documented, implemented, reviewed and continuously improved, and so furnished with personnel, equipment and resources, as to ensure that specifications set to achieve the intended product quality standards are consistently met. The attainment of this quality objective requires the involvement and commitment of all concerned at all stages of manufacture.

Explanatory Note

2.1 A manufacturer has to comply with the legal requirements relevant to the product manufactured, both in the country where manufacture takes place and the countries where the product is destined for export. The term ‘manufacturer’ is used here not in an abstract sense, but instead referring to the person who has overarching responsibility for the manufacturing operation and for ensuring that good manufacturing practice (GMP) is embedded into the day‐to‐day operation of the organisation. From a legal perspective, it is this person, for example in United Kingdom (UK) legislation they are termed the ‘business operator’, that ultimately has responsibility for ensuring all food products are safe and legal. While embracing these legal requirements, she/he or their appointed designate(s) will have also determined the market requirement that she/he aims to meet, and therefore the overall product quality standards the product needs to meet.

These standards can be intrinsic (i.e. associated with the innate nature of the food product) or extrinsic (i.e. relate to the way the ingredients, or the product as a whole, has been produced and processed often prior to manufacture). Extrinsic standards can include, but are not limited to, farm production standards, worker welfare and other ethical standards, environmental standards and so forth. Thus the product specification that is established as a result embodies both legal requirements (e.g. those of composition, safety, hygiene and labelling) and market requirements (such as product nature, appearance, flavour, texture, presence or absence and quantity of particular nutritional components, nature of pack, pack size, degree of inbuilt convenience, shelf life, presentation, extrinsic standards and price and so forth). While some commercial and marketing considerations affecting the market requirement specification are outside the scope of this Guide, those relating to the principles of design and development of products and processes to comply with that specification are dealt with in Chapter 12. The product and process design, when completed and validated, then becomes a part of the full product specification. Once established it remains permanent until formally changed. All references in this Guide to compliance with product specifications imply compliance with all of the foregoing requirements described as being embodied in the term ‘specification’.

2.2 In order to achieve the objectives of GMP, it is necessary to have in place:

1. Quality Assurance: that is, to design and plan, as relevant, raw material specifications, ingredients formulation, adequate resources such as processing equipment and environment, processing methods and conditions, intermediates specifications, appropriate packaging and labelling specifications, specification for quantity per pack, specifications for management and control procedures, a specified distribution system and cycle, and appropriate storage, handling and preparation instructions, which, taken all together, are capable of resulting in products consistently complying with the product specification and providing confidence that the products will consistently meet the product specification. These will form elements of the quality plan for the product (see 12.9). Furthermore, an effective verification system confirms that the quality plan, and associated quality activities, and the manufacturing operations will consistently deliver products of the specified quality both at a given point in the production process and throughout the product’s shelf life.
2. Effective Manufacturing Operations: that is, to validate and manage the operational production/distribution practices to ensure that the capability is translated into reality, so that firstly the process itself adheres to specified design parameters and secondly that the resulting products actually do consistently comply with the product specification (see Decision Makers’ Summary). This is relevant for quality, legislative and food safety criteria. Within the manufacturing operations there will be steps in the process where it is critical at that point to effectively manage quality. These points are often termed critical quality points (CQPs) and will also be included in the organisation’s quality plan(s) with associated criteria, quality limits and monitoring and verification plan. Within the manufacturing operations there will be steps in the process too where it is critical at that point to control food safety. These points are often termed critical control points (CCPs) and will be identified in the organisation’s food safety plan with associated preventative (control) measures, critical limits and monitoring and verification plan (see Chapter 3).
3. Quality Control: that is, to have in place an effective monitoring system that checks compliance with specified requirements and defines suitable corrective action in the event of ‘out‐of‐control’ occurrences.
4. Food Control: that is, to have in place an effective management system that ensures food safety, legality, quality and integrity criteria are consistently met (see Decision Makers’ Summary). An effective food control system requires well‐qualified and appropriately experienced individuals working in food control management participating in the development and validation of process controls and specifications that address the safety, legality, quality and integrity of food; competent staff and adequate facilities to do all the relevant inspection, sampling and testing of materials, and monitoring of process conditions and relevant aspects of the production environment (including all aspects of hygiene) and management of potential food safety hazards and food integrity threats; verification activities that are developed and implemented by appropriately experienced personnel in order to demonstrate that the food products and the process are under the appropriate level of control; and 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 to be approved as fit for either further processing or sale, or to be segregated for decision as to appropriate disposition, for example reject, regrade or reprocessing.

Good Manufacturing Practice

2.3 Thus, GMP may be viewed as having two complementary components, namely effective manufacturing operations and food control (see Figure 1).

Food Integrity

2.4 The Elliott Review of 2014 considered the integrity and assurance of food supply networks. The Review was written following the 2013 European horsemeat incident where horsemeat was substituted for beef in a range of products. The report produced as a result of the Review stated that food integrity was not only concerned with the nature, substance and quality and safety of food, but also involved other aspects of food production such as the way food has been ‘sourced, procured, and distributed and being honest about those areas to consumers’.¹ The design of food integrity management systems (FIMS) in food manufacturing is in its infancy as this version of the Guide is being written. The writing of a Codex Alimentarius Commission Standard that focuses specifically on food integrity has begun, but its issue will postdate this Guide. Food crime, the design of FIMS, food crime risk assessment, security and countermeasures are addressed in Chapters 5 to 7 of this Guide.

Quality Management Systems

2.5 Many manufacturers will have developed their own QMS, but increasingly are attaining or seeking to attain certification to a private QMS standard. EN ISO 9000:2015 is an international standard concerned with QMS design, and it describes the requirements of a QMS to assure conformance of product and production to specified requirements. BS EN ISO 22000:2005 is a complementary standard that addresses food safety management systems (FSMS) and the requirements for any organisation in the food chain. As a result of the increasing globalisation of food production, other private QMS standards have been developed specifically for food manufacturing. These include the British Retail Consortium (BRC) Global Standard for Food Safety. The Global Food Safety Initiative (GFSI) Standard has been developed to benchmark international private standards and both of these documents are referred to within this Guide.

Effective Manufacturing Operations

2.6 An effective manufacturing operation is one where, as appropriate:

1. the manufacturing process, equipment, activities, precautions and so on are fully specified in advance, and systematically reviewed in light of experience;
2. the necessary facilities and resources are provided, including:
   1. appropriately qualified personnel,
   2. adequate premises and space,
   3. suitable equipment and services,
   4. specified materials, including packaging,
   5. specified policies and procedures, including cleaning procedures, and
   6. suitable storage and transport;
3. the relevant written procedures are provided in instructional form and using clear and unambiguous language, and are specifically applicable to the facilities provided;
4. operators are trained, instructed and motivated to carry out the procedures correctly, and refresher training is undertaken at appropriate intervals;
5. records are made (whether manually, by recording instruments or both) during all stages of manufacture, which demonstrate that all the processing steps required by the defined procedures were in fact carried out, and that the quantity and quality of product produced were those expected;
6. records are made and retained in legible and accessible form, which enables the history of the manufacture and distribution of a batch to be traced;
7. a system is available to withdraw or recall from sale or supply any batch of product, if that should become necessary; and
8. a review system is in place to consider actual operational performance against proposed performance and drive the implementation of appropriate preventive and corrective action where appropriate.

Quality Control

2.7 Quality control is the function concerned with determining the compliance of finished products with specifications and with the activities ancillary thereto. It includes the undertaking of inspections and tests to determine the degree of compliance with specifications, the examination of process control data and the provision of rapid information and advice leading to corrective action where necessary. It is therefore a ‘lag’ activity designed to detect product and process failure rather than, in the case of quality assurance activities, to prevent product and process failure in the first place. The term is also used to designate the department responsible for this function within a manufacturing organisation. What is described in this guide in terms of quality control personnel and their activities does not preclude automatic process adjustment by negative feedback from automatic process monitors/recorders, or production operators receiving such information on‐screen and then taking appropriate action, provided that they are suitably trained, and that such procedures are written into the quality control system and that any actions undertaken by personnel are recorded.

Food Control

2.8 The Institute of Food Science & Technology (IFST) uses the term ‘food control’ to describe a comprehensive system that encompasses the QMS, the FIMS and a FSMS based on the principles of hazard analysis critical control point (HACCP). It is vital that the FIMS and the FSMS, and associated prerequisite programmes (PRPs) and countermeasures (see Chapter 7), interlink with aspects of quality assurance and quality control within the QMS that are appropriate to the products and processes involved and the inherent level of food safety and food integrity risk (see Chapters 3 and 6).

In describing the role of the quality manager below, it is recognised that alternative job titles may be used in a particular setting, but it is important for all food manufacturing organisations to distinguish clearly the management roles of quality assurance (failure prevention) and quality control (failure detection), especially where these are in practice managed by the same person. Effective food control requires that, where appropriate:

1. the quality manager participates, with others as necessary, in the assurance role of development and approval of specifications, liaising with suppliers in agreeing product specifications and service requirements, and the control function of assessing and approving suppliers on the basis of their ability on an ongoing basis to supply reliably in compliance with the specifications;
2. adequate resources, facilities and staff are available for sampling, inspection, testing and sensory assessment of starting materials (including packaging materials), intermediates and finished products, and for monitoring process and storage conditions and relevant aspects of the production environment (including all aspects of hygiene);
3. all samples used for inspection and testing are representative of the batch being sampled, and are collected by personnel under the direction of, and examined with methods approved by, the quality manager. The results of such examination(s) need to be formally assessed against the specification by the quality manager or a competent person designated by him/her to undertake the task;
4. established procedures are developed, validated, implemented and verified that ensure starting materials and all intermediates are approved unconditionally for use, alternatively are rejected or thirdly designated for a treatment that is intended to bring them within specification, in line with any inspection/test results obtained;
5. there is rapid feedback of information (accompanied, where appropriate, by advice) to manufacturing personnel, enabling prompt adjustment or corrective action to be taken when necessary, and, in the case of raw material, rapid feedback to the purchasing/procurement function;
6. a positive release procedure exists, where appropriate, whereby batches of finished products are temporarily quarantined until formally released for rectification, or into normal stock, or for distribution. The use, or lack of use, of a positive release procedure should be determined by an appropriate risk assessment process which is formally undertaken, documented and then reviewed at a frequency deemed necessary in light of operational changes or incidents that may occur;
7. sufficient reference samples of raw materials and packaging, or records of the result of their inspection, where deterioration could occur, should be retained to permit future examination and analysis, if necessary;
8. sufficient reference samples of finished products are retained for shelf‐life tests and to permit future examination and analysis, if necessary;
9. customer/consumer complaint samples are examined, the causes of defects are investigated where possible, and appropriate measures are advised and implemented for appropriate corrective action to prevent recurrence;
10. summaries of quality performance data, in an appropriate form, are provided by quality control to operating functions (e.g. general management, production management, purchasing and cost accounting). These summaries may provide input in the determination of food safety and quality objectives for the business whereby data are routinely analysed to determine performance against defined targets and potentially identify areas for improvement;
11. a direct interest is taken in the activities and quality assurance procedures of the suppliers of raw materials and packaging materials, and close contact is maintained with their quality assurance departments;
12. ongoing contact is maintained with the relevant enforcement authorities and matters raised by them are investigated and responded to; in the UK the Food Standards Agency (FSA) and the ‘Home Authority’ will provide useful contacts;
13. due heed is taken of new developments in food legislation, especially on changes in compositional standards and labelling requirements that may necessitate changes to specifications for raw materials or finished products, and on European Union (EU) and UK Government proposals for future food legislation and in the countries to which the food manufacturer exports; and
14. the authority and responsibilities of the production management and the quality management functions, respectively, are clearly defined so that there is no misunderstanding (see Chapter 17).