12 PRODUCT AND PROCESS DEVELOPMENT AND VALIDATION – Food and Drink – Good Manufacturing Practice, 7th Edition



Products should be designed to ensure that the end product meets consumer expectation within the intended and anticipated circumstances of use, and to ensure that product design and performance have been fully evaluated for the required function in respect of microbiological safety, chemical safety, physical safety and sensory quality as elaborated in Chapter 2. To this end, a hazard analysis critical control point (HACCP) study undertaken by a multidisciplinary team is recommended, preferably applied from the earliest stages of product or process development with a view to eliminating or minimising potential hazards wherever possible and incorporating effective control parameters in the product design (see Chapter 3). The HACCP study should encompass any possible deviations from the design objectives. It is important to consider all realistic potential hazards that may occur at each stage of the manufacturing process. In order to design the product to achieve these objectives, it is necessary to identify all the possible causes of the identified deviations. A hazard analysis and operability (HAZOP) study is a recognised hazard analysis method used during process development and validation to identify both food safety hazards and potential operational issues that could lead to food safety or environmental hazards or impact on manufacturing efficiency (see Chapter 3). Similar considerations apply where changes are made to existing products that would affect the integrity, safety or stability of a product. Such changes could include those made to:

  1. ingredients or supplier;
  2. formulation or recipe;
  3. operations, e.g. order of addition;
  4. machinery;
  5. processes or process parameters;
  6. packaging;
  7. storage;
  8. distribution;
  9. organisational structure or staff responsibilities; or
  10. consumer use.

The above list is not exhaustive but is based on experience of situations where failure to take such changes into account has resulted in serious human or commercial consequences or both.

Customer Requirements

12.1 Before commencing the design procedure, it is advisable to define the customer and/or consumer expectations of the new product or process. These should be established by market research or by direct agreement with the customer (e.g. the retailer, caterer or distributor). If established by market research, these expectations should be translated clearly into design objectives. It is also important to consider whether the food is targeted at a section of the population that is deemed as a vulnerable group with regard to food safety, for example the elderly, the young, pregnant women or immunocompromised individuals, and the possible implications in terms of product design. Customer requirements may include the utilisation of recognised food safety hazards, for example allergens in the product formulation, a formulation, packaging design or manufacturing process that may lead to higher risk of pathogen survival, or the use of packaging that in itself presents a food safety hazard, for example glass, brittle plastic or metal. Some products or food ingredients may be more vulnerable to integrity issues, such as very expensive spices that can potentially be substituted with inferior material and/or other ingredients that are liable to supply shocks caused by drought, weather impact etc. It should be noted at the start of the product development process if there is the potential for a risk of loss of integrity that cannot then be appropriately mitigated.

12.2 Due account should be taken of any specific standards that are to be met to justify special claims (including those related to packaging), specified requirements such as suitability for a specific nutritional or health purpose, or other particular expectations, for example:

  • provenance and geographic location;
  • environmental benefits, e.g. recycling,
  • use of novel technology;
  • claims of being free from specific ingredients, e.g. sugar free;
  • specific production method: halal, kosher, organic, vegan, vegetarian;
  • animal welfare friendly;
  • diabetic or other health‐related product; or
  • low‐carbohydrate, low‐fat or suitable for a low‐calorie diet.

Those claims that could be attributed to the product should be agreed before beginning the design process.

Design Objectives

12.3 Before commencing the design of a new product, design objectives should be established clearly, having due regard to the following requirements:

  1. customer/consumer expectations;
  2. product safety;
  3. product integrity, including the need for authenticity markers;
  4. regulatory requirements for the intended market; and
  5. minimising operating costs while remaining consistent with the fulfilment of (i), (ii) and (iii).

Design objectives should include acceptance criteria and tolerances. Establishing tolerances is crucial to achieving customer expectations at a realistic cost. They may be established by past precedent or by agreement with the customer (e.g. the retailer, caterer or distributor).

Regulatory Requirements

12.4 Where regulatory requirements include statutory maxima or minima for particular parameters, the design targets should provide at least sufficient margin below the maxima or above the minima to allow for ingredient composition variation, within and between batch variation and process variation.


12.5 Planning for a new process or product should include clear identification of responsibilities for the design activities, agreed actions and timescales. This is best achieved through a multidisciplinary project team, which could comprise technical, production, engineering, marketing, and purchasing and distribution expertise. In the event of changes to existing products, packaging or processing methods, the existing HACCP plan(s) and food safety management system (FSMS), quality management system (QMS) and food integrity management system (FIMS) needs to be reviewed by the HACCP team and/or project team if they are the same group of individuals. Any proposed changes should be validated. Validation should include a range of trials as applicable to the situation (see 12.6). Validation is the collection and evaluation of ‘scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards’.1

When a new product is proposed, the HACCP team should consider whether the product is addressed by an existing food safety/HACCP plan, or whether a new HACCP plan needs to be initiated. In the event of a new packaging or process system being introduced, a new HACCP plan needs to be developed. New HACCP plans or a modified existing HACCP plan must be approved by the HACCP team before factory trials can take place.

Quality, Safety and Integrity Planning

12.6 At each critical stage in the design process (e.g. kitchen, pilot scale, pre‐production factory trials, first production, packaging trial, distribution (transit) trial, retail trial) it is essential to verify that the product meets its agreed design criteria and agreed tolerances, and that the HACCP study has been successful in effectively managing food safety hazards. This can be achieved in a number of ways, including:

  • shelf‐life testing;
  • quality control testing of microbiological, chemical and sensory parameters and packaging;
  • market trials;
  • process monitoring; and
  • checks for compliance with regulatory requirements.

The trials should be undertaken in accordance with documented procedures and the results of the trials should be documented and retained. If the factory trials and associated testing form part of the validation process for the HACCP plan and general FSMS and FIMS, these should be referenced within the HACCP documentation. The FSA publication E. coli O157 – Control of cross‐contamination: Guidance for food business operators and enforcement authorities (2014) stresses the importance of not only validating the HACCP plan, but also focusing on validating the control measures in place to ensure that bacterial loading on fresh produce is reduced on receipt, that physical separation of materials is effective and that disinfectants are purchased and used in compliance with validated dilution levels and contact times.

Traceability of materials used in factory trials is critical, and trial ingredients, in‐process material and finished product should be suitably labelled, segregated and controlled to ensure that it does not enter the general stock system. If the materials used are, or contain, potential allergens, then allergen‐control procedures should be followed (see Chapter 8).

12.7 Nutrition analysis should be undertaken to ensure that at the end of the shelf life, nutrient values comply with the product label, especially where the original design phase involved calculation of nutrition content from standard sources. This is critical where nutritional claims are made for the product, for example ‘free from’, ‘high in’ and ‘low in’ claims.

12.8 A food crime risk assessment needs to be undertaken to determine the potential vulnerabilities associated with the new products and any potential integrity risk, or areas where transparency is weak or there are potential threats that need to be adequately controlled (see Chapters 5 to 7).

12.9 A quality plan needs to be developed to manage key product quality parameters. Guidance on the development of quality plans can be accessed in ISO 10005:2005 Quality management systems – Guidelines for quality plans.

12.10 Failure to achieve the design objectives can be caused by three factors: unrealistic initial design objectives, an inadequate HACCP study, risk assessment or quality plan, or failure to implement the requirements properly within the product development process. In all cases the entire new product development procedure should be revisited, although revision of the initial objectives and design criteria may be considered if the end result is demonstrably acceptable to the manufacturer and their customers in all respects despite the failure to meet an original design objective that is no longer deemed necessary. If the objectives are changed at any point during the design and development process, a thorough re‐evaluation of the implications of the changes in terms of food safety, integrity and quality must be made.


12.11 Checks should be undertaken to ensure that the labelling of the new product is legal and in accordance with the formulation and product specification. These checks should include weight control and volume control information, nutrition information, allergen information, customer storage instructions, cooking and preparation methods and other instructions for use, and product durability information (see Chapter 37).