2. Document management
The product safety and quality management system
Document control, record keeping, customer focus and contracts
The standards
This article is written to meet the following sections of the Standards:
| BRCGS Food Safety Issue 9 | 3.1 Food safety and quality manual 3.2 Document control 3.3 Record completion and maintenance 3.4.3 Internal audit records 3.5.4.5 Contracts and traceability |
| BRCGS Packaging Issue 6 | 3.1 Product safety and quality management system 3.2 Document control 3.3 Record-keeping 3.9.1 Use of subcontractors |
| BRCGS Agents & Brokers Issue 3 |
3.1 Product safety and quality systems manual 3.2 Documentation control 3.3 Record completion and maintenance 3.4 Customer focus and communication 4.2.5 Subcontracted services |
| Storage & Distribution Issue 4 | 3.1 General documentation requirements 3.4 Customer contractual arrangements 3.5.2.1x Management of subcontractors 10.3.2.1, 10.3.2.2 Customer focus and communication 13.1 Contractual arrangements (all services) 13.7 Contracted services records 14.2 Inspection contract review 15.1 Contract packing |
| FSSC22000 Version 5.1 | ISO 22000:2018 7.5 Document information |
| IFS Food Version 7 | 2.1.1 Document management 2.1.2 Records and documented information 4.16.6 Maintenance supplier contracts |
| SQF Edition 9 | 2.2 Document Control and Records |
The requirements
Management system
Purpose
The company shall develop, implement and effectively manage a document management system which meets the requirements of the certification standard and the customer’s requirements.
The management system will be made up of instructional documents (e.g. procedures, work instructions, standard operating procedures) and records.
The system will be continually reviewed to ensure that it is kept up-to-date.
The system must be managed, so that the records can be accessed efficiently for audit, mass balance and traceability within 4 hours.
Instructional documents
Instructional documents (e.g. procedures, work instructions, standard operating procedures) must be:
- Legible and written so that anyone can understand.
- Detailed enough to enable them to be applied correctly.
Where written explanation is not sufficient to make information clearly understood pictures, photographs or diagrams should be used.
Point of use work instructions
Instructional documents must be:
- Accessible at point of use.
- Available to relevant personnel.
Language
Translation of documents into appropriate languages should be considered. Where translations are used, a record must be kept of who completed the translations and the details of the language used.
When an interpreter is used, both the interpreter and the staff member being trained should sign the training record, to confirm that the translation version has been understood.
Where written communication alone is not sufficient, pictures, photographs and or diagrams must be used.
Group systems
If the site is part of a company that is governed by a head office, the interaction between the system of the site and the system of the head office should be clear.
All policies and procedures that are necessary for assessing the operation of the site, must be available at the site.
Review
To ensure that the management system is always kept up-to-date, applicable standards will be constantly monitored for change. Where a change is highlighted, a review will be instigated to establish if updates are required to the documents within the management system.
Retention
All records must be retained for a defined period of time, which must consider:
- Any legal or customer requirements.
- The shelf life of the product (this must take into account where it is possible for the consumer to extend the shelf life e.g. freezing).
At a minimum all records must be retained for at least the shelf life of the product plus 12 months.
Where products have an undefined shelf-life, the company must define a reasonable retention period based on:
- Customer usage.
- Time for complaints to be notified.
- Any legal precedents.
It would usually be at least 3 years in these situations.
Training records for full and part time permanent staff must be retained for the duration of the employee’s employment plus 3 years.
Internal audit reports, non-conformities, corrective, preventive actions and their verification, must be kept for at least 2 years.
Digital documents and records
Where documents and records are stored electronically, they shall be:
- Securely stored (e.g. authorised access, password protected, there is control of amendments).
- Backed up to prevent loss or malicious intervention.
The company must be able to demonstrate how the documents are controlled, and what safeguards are in place.
Electronic documents must adhere to the document control procedure.
Consideration should be given to testing the electronic retrieval systems, with records of the tests being retained.
If the controlled documented are all on an electronic system, printed copies must be authorised (e.g. with a signature or stamp), to show they are for use.
Consideration should be given to the most effective way to communicate changes to the relevant staff.
Amendments of changes to electronic entries must be retained, such as programme settings.
Document control
There must be a procedure in place to manage the documents that are part of the product safety and quality system.
This procedure must include:
- A list of all the controlled documents, and the latest version number.
- How controlled documents can be identified and how they are authorised.
- A record of changes or amendments to the documents, and the reason for them being made.
- Details of the system for replacing existing documents when they are updated.
- Archived documents will be retained for a defined period, based on legal customer requirements.
Record Keeping
Records
Records shall be:
- Accurate following the instructional document.
- Legible.
- Contain genuine information (e.g. prescribed or adjusted times are not to be used).
- Initials and signatures must be traceable back to the individual.
- Signed and dated by the person completing them.
- Verified by someone who didn’t complete the checks.
The use of pencils or correction fluid is not allowed.
If mistakes are made, the inaccurate information must be neatly crossed through, with the reason for the change being noted and initialled by the person making the change.
Record archiving
The records must be organised so that they are accessible and can be found easily.
The system should provides an overview of how all of the records are filed and where they are archived.
There should be a mechanism in place to make sure that records are complete, accurate and in good condition before they are filed.
Records must be stored appropriately so that when they are retrieved they are still legible (e.g. not damp due to poor storage conditions).
Customer focus
Customer requirement
The company must have a system in place to identify if customers have specific requirements. Any specific requirements will be made known to all relevant staff and kept up to date.
When customer policies need to be enacted by manufacturing, processing or packing sites, the company shall effectively communicate them to the relevant suppliers of products or services. This should be done through product specifications, contracts with suppliers/service providers or codes of practice.
There must be available records of the company being notified of requirements, the communications to the relevant suppliers, and supporting documentation which confirms the suppliers have understood and implemented the requirements.
Customer KPIs
The company must have key performance indicators that relate to the customer requirements, the performance will be measured, and the results communicated to all relevant staff.
Supply of information
When a customer requires information to approve the last manufacturer or processor of the product, the company will provide this information, including the identity of the manufacturer or processor.
Contractual arrangements
Customer agreement
Any customer requirements for the storage and/or distribution of their product must be agreed and documented with the customer prior to the work. This includes specific handling requirements for the product(s) such as:
- Temperature.
- Humidity.
- Light conditions.
- Stack height.
- Compatibility requirements.
- Any limitations on the acceptance of goods (e.g. partial pallets, unprotected pallets, pallet configuration, product received outside of usual handling temperature and damaged or contaminated product).
They must also be in place for any services that are provided by the company. It must clearly define service expectations and ensure that any potential food safety risks associated with the service have been addressed. This could be in the form of a company issued specification, where a customer-issued specification doesn’t exist.
Customer contract review
Prior to putting a new customer agreement in place, the company must undertake a documented review of:
- The site’s ability to meet the requirements consistently.
- An evaluation of the effect of the requirements on other products the site handles (e.g. potential tainting from strong smelling products or allergen contamination).
The company must have the ability to meet customer requirements without compromising the quality, safety or legality of the customer’s product and any other product handled.
The review should be repeated routinely, where required by the customer.
Any changes to existing agreements or contracts must be agreed, documented and communicated to all relevant personnel.
Resources
The company must ensure that the required resources and equipment is provided so that all customer contracts are met.
There must be procedures in place for any services undertaken, and staff must receive the appropriate level of training, so that they are understood by staff responsible for the work.
Subcontracting agreement
Where activities are subcontracted, the contract with the subcontractor must include the requirements that they must:
- Work in accordance with the relevant legislation.
- Maintain product traceability.
- Work in accordance with the requirements identified by the hazard analysis plan.
- Not subcontract any part of the contract without prior written agreement.
Where any process is subcontracted for customer branded product, this must be declared and agreed in writing with the customer prior to use.
Subcontracted processes must meet the customer contracts and specifications already in place.
e-Commerce T&Cs
Agreements must be in place between the company and customer which clearly define service expectations and ensure that potential risks associated with the service have been addressed. These are usually in the form of terms and conditions, on-line product information and order documentation (which is a form of electronic contract).
These shall include information on (where appropriate):
- Delivery periods.
- Specific product-handling instructions.
- Change/cancellation options.
- Substitution policy.
- Returns policy.
- Contact details.
Hazard analysis
The company must ensure that all of the services and products that they provide are included in the hazard analysis. Any new products or service components must be assessed to identify any additional potential risks, and their appropriate controls. The company must take into account the source of potential hazards and where they may arise from subcontracted service providers.
BRCGS Food Safety Issue 9
There haven’t been any significant changes that affect this topic.
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