7. Product development
What are the key aspects of a good product development system?
We look at the steps, hazard controls, trials, samples, and validation.
The standards
This article on the product development system is written to meet the following sections of the standards:
BRCGS Food Safety Issue 9 | 5.1 Statement of intent 5.1.1, 5.1.2, 5.1.3, 5.1.4 Product design and development 5.2.4 Product labelling 5.3.4 Management of allergens 5.4.7 Product authenticity, claims and chain of custody 5.5.3 Product packaging |
BRCGS Packaging Issue 6 | 5.1.1, 5.1.5 Product development 5.2.2, 5.2.3, 5.2.5, 5.2.6, 5.2.7 Graphic design and artwork control |
BRCGS Agents & Brokers Issue 3 | 4.6.1, 4.6.2, 4.6.3, 4.6.5 Product design and development |
BRCGS Storage & Distribution Issue 4 | 10.3.4.1, 10.3.4.2, 10.3.4.4, 10.3.4.5, 10.3.4.6 Product design and development 12.5.6 Packaging system performance – testing and validation |
FSSC22000 Version 6 | 2.5.13 Product design and development |
IFS Food Version 8 | 4.3.1 Product development |
SQF Edition 9 | 2.3.1 Product Formulation and Realization |
The requirements
The product development procedure
There must be a procedure for the development, assessment and approval of new and existing products. The procedure must include:
- The steps of the product development process including; project brief, hazard analysis, trials, product review, product approval.
- Responsibilities at each step.
- Customer requirements relating to design, development, specification, manufacture and distribution of the product.
Documentation must be collated during the development process, including:
- Product development briefs.
- Trial information.
- Validation evidence.
- Customer approvals.
- Pack copy.
- Artwork.
- Specifications.
- Approval samples and masters.
Where documents, are kept in digital format, they must be:
- Suitably protected to prevent loss.
- Secure to prevent alteration by unauthorised personnel.
Design requirements
All parties must agree, review and approve the product brief, to ensure that the product developed:
- Meets the customer’s expectations.
- Can be manufactured consistently to specification.
- Meets the functional requirements of the customer and the final consumer.
- Is legal.
The product brief must include:
- A description of the product.
- Any compositional requirements.
- Quality, functional and safety parameters.
- Any requirements for recycled materials.
The brief should be in place before the new product is progressed.
Control of hazards
The site must understand the product safety rationale and legal requirements for all new products.
Any parameters critical to the product shall be identified and defined, to ensure that new products are developed within these guidelines:
- Barrier requirements.
- Maximum/minimum use temperature.
- Machine running.
- use of recycled materials.
All new products and changes to existing product formulation, packaging or methods of processing shall be formally approved by the HARM team leader or an authorised HARM team member.
This is to ensure that hazards have been assessed and suitable controls, identified through the hazard analysis system are implemented prior to trials.
The approval must be documented, even where no action is required.
Consideration must also be given to product safety requirements that require ongoing verification, such as any free from claims or functional requirements.
Sample approval
Product samples must be formally reviewed against the brief.
Where customers samples to be kept, their requirements must be followed.
Customer approved reference material or control samples of product, packaging, artwork or colour standards, must be controlled and stored to minimise degradation.
Where degradation can’t be prevented (e.g. fading of colour due to light, or shelf life of samples) and therefore, the renewal of reference materials or control samples are required; a procedure must be in place, which details how they can be created and approved.
Product samples, artwork and associated processing equipment (e.g. plates, tooling/moulds) must be approved, prior to launch to confirm that the product meets the agreed specification.
Processing trials
Where allergenic materials are brought onto site for product development, that are not on the approved allergen tracker, they must be controlled.
Where allergenic materials are required for trials, they must be risk assessed through the new product development process, before they are approved to enter the factory.
Processing trials must be carried out to validate that the product formulation, the process, and to ensure that a consistent product can be produced, which meets the required specification.
Where trials are not necessary, the justification for this must be documented.
Records of trials and results must be retained as evidence.
Trials must be carried out where:
- The product formulation or artwork is new, or has been updated.
- The packing format, unit or pallet configuration is new.
- The processing of the product differs from current products.
- New or recommissioned equipment is to be used.
- The agreed specification parameters are more stringent than current product.
- There is a change to the transit process.
- As requested by the customer.
Trials of the full process may not be necessary, but must meet their objectives – which is to validate the aspect that is new or has changed.
Prior to trials taking place, the following must be agreed:
- What samples are required from the trial.
- What changes to the formulation or processing parameters are required.
- The success criteria of the trial, e.g. throughput rates, specification parameters.
Sufficient processing data must be collated during the trial, in order for processing specifications to be generated. The information may include:
- Equipment settings.
- Throughput speeds.
- Processing methods.
- Product parameters and acceptable limits.
Validation
Samples from trials must be used to validate that the product meets the agreed specification, this may include:
- Nutritional
- Sensory (flavour, colour, appearance).
- Physical attributes.
- Functional requirements.
- Shelf life.
- Preparation or cooking instructions.
Shelf life validation must be carried out following documented protocols that take into account:
- Worst-case conditions (e.g. temperature) that the product is subjected to during processing, handling, distribution and where applicable consumer handling.
- Any rework, or work in progress materials, used in the product that will affect shelf life.
- Safety requirements for microbiological or chemical testing.
- The use of quality attributes standards for sensory analysis.
- A margin of safety, so that shelf life is validated to slightly beyond the intended life.
- Sampling rules, e.g. start, middle and end, and the number of batches.
- Recording of the method and results.
Where theoretical analysis is used to determine the shelf life of long-life products, the theory and justification must be documented.
The validation must consider the criteria for ongoing verification, during the lifetime of the product.
Even where the business is not responsible for the cooking instructions, they must remain accountable.
There must be validation and verification in place for products labelled with claims.
Obsolete items
Where materials, artwork, printing equipment or packaging becomes obsolete, due to product life cycle or development, there must be a procedure in place to manage these items, to ensure that they do not get used by mistake. The procedure must include:
- A system to prevent accidental use of obsolete items.
- Maximum timescales for disposal.
- How obsolete items will be disposed of.
- A process for rendering trademarked materials unusable.
Transit trials
Packaging must be designed to ensure effective that the product meets the specification. Transit trials must be carried out using worst-case scenarios to confirm this.
This validation must consider:
- The distribution environment, taking outside temperature into account where this has an impact.
- The different type of distribution channels (e.g. road, sea)
- Unit and SKU configuration and measurements (e.g. dimensions, weight).
- Mixed load requirements
- Handling and storage requirements (e.g. leakage, damage)
- Load plan requirements (including weight and minimum/ maximum loads)
- Re-usage of any component of the packaging system
- Product (e.g. tampers) and vehicle security (e.g. seals)
- Legal requirements.
BRCGS Food Safety Issue 9
5.1.1 A procedure is now needed for product development.
There’s an additional requirement that the procedure should ensure that claims are considered when developing products.
The interpretation has been rewritten. A procedure must be in place which details the stages in the development process and ensures that each are controlled to prevent risk to the product.
5.1.4 Additional wording has been added for clarity, but it doesn’t change the expectations of the clause.
Examples of why shelf life must be established accurately have been provided. This doesn’t change the meaning of the change, but it’s possible with the addition of the text that the expectations will be higher. Therefore, focus is needed to ensure that current systems are robust.
5.2.4 Further clarity has been provided regarding the accountability for cooking instructions – the site must remain accountable even where the activity is carried out by another party.
5.4.7 Issue 8 clauses 5.4.6 and 5.4.7 have been combined.
Issue 8 clause 5.4.6 was focused on nutritional claims. This has now been expanded to include all claims for authenticity purposes. There’s been an addition to the clause to reiterate that claims must be proven and that they must meet legal requirements.
Further clarification has been provided so that the process must be assessed for potential cross-contamination risks which will impact claims – this is essentially, the beginning of an M&S integrity style requirement.
This requirement has always been in the clause, although it’s never been pushed before – probably because auditors have never understood what it meant before, so this is a big change and requires careful attention.
No longer is validation focused on nutritional claims, but it stresses that this must be for all claims. This means that the process must be validated to identify process controls to ensure that claims are met.
Excellent and very informative, thank you
Very good document. Thank you.