Principle

Effective documentation is an essential and integral part of good manufacturing practice (GMP) and, in particular, one of the essential features of a properly operated quality management system (QMS), hazard analysis critical control point (HACCP) plan, food safety management system (FSMS) and food integrity management system (FIMS). The purposes of formalised (documented) systems are to define the scope of the management systems, the materials, operations, activities, control measures and products; to record and communicate information needed before, during or after manufacture; to reduce the risk of error arising from oral communication; and to develop records that form a vital part of the audit trail necessary for tracing components used to produce the final product. The system of documentation should be such that as far as is reasonably practicable the history of each batch of product, including utilisation and disposal of raw materials and packaging, intermediates and bulk or finished products, may be ascertained.

General

13.1 Documents fall into three main categories:

1. manuals, which define company strategy, policy and protocols and how the organisation may seek to address a QMS standard such as ISO 9001:2015 Quality management systems – Requirements, or the British Retail Consortium (BRC) Global Standard for Food Safety;
2. procedures, which define the company prerequisite programmes (PRPs), countermeasures and system procedures such as customer complaint procedures, management of incidents and product recall, traceability or calibration procedures; and
3. work instructions, standard operating procedures, specifications and master forms. These are the documents that define production activities and identify the quality standards and control checks that need to be undertaken. A master form is the blank template, which once completed becomes a quality record. These records can often form part of the organisation’s due diligence documentation.

Failure to undertake the required activities and complete the appropriate records will nullify many of the benefits of GMP, food integrity management or effective manufacturing operations and effective food control. Documents may include the following types.

1. Manuals and policies, including:
   • quality manual;
   • HACCP manual/plan;
   • health and safety manual;
   • Control of Substances Hazardous to Health (COSHH) manual (in the United Kingdom (UK) or equivalent elsewhere);
   • quality policy;
   • food safety policy;
   • food integrity policy;
   • allergen policy;
   • environmental policy;
   • ethical trading policy; and
   • health and safety policy
2. Procedures and programmes, including:
   • production programmes;
   • training programmes;
   • internal quality audit programme;
   • pest control programme;
   • plant maintenance programme;
   • procurement procedure;
   • supplier approval and performance monitoring programme;
   • management of incidents and product withdrawal and recall procedure;
   • quality control (including analytical and microbiological) procedures and methods;
   • premises housekeeping and hygiene, including cleaning schedules;
   • traceability procedure;
   • calibration procedure;
   • personnel hygiene procedure;
   • document control procedure; and
   • quality records management procedure, including archiving.
3. Work instructions, standard operating procedures, specifications and master forms such as:
   • ingredient specifications;
   • packaging materials specifications, including artwork standards;
   • copy of order and/or terms of conditions of purchase;
   • master manufacturing instructions, job notes and material resource planning instructions, including flowsheets and standard recipes;
   • work instructions and task procedures;
   • product formulations;
   • intermediates specifications;
   • bulk products specifications;
   • finished products specifications; and
   • machinery operating instructions.
4. Records and reports (system records)
   These documents in particular should be designed with due regard to intelligibility to the intended user, including the need to recognise possible numeracy, literacy and language problems. These documents include:
   • records for monitoring of critical control points (CCPs) and critical quality points (CQPs);
   • records of receipt, examination, approval and issue for use of raw materials and packaging materials;
   • records of the testing and release of intermediates, bulk products and finished products;
   • records of process control tests;
   • in‐process recording instrument charts;
   • weight or volume control charts;
   • batch manufacturing records;
   • customer complaint and service level reports;
   • minutes of management system review meetings;
   • quality control summaries and surveys;
   • quality assurance, audit reports and records; and
   • superseded documents.
5. Additional system documentation, including
   • site plans, e.g. water system plans, plant layout, drainage plans;
   • copies of applicable codes of practice and relevant legislation; and
   • equipment manuals.

13.2 Detailed advice on documentation related to specific production categories and specialised topics are contained in many of the chapters of this Guide. These chapters should be consulted in conjunction with this chapter.

Quality Manual

13.3 A quality manual should outline the structure of the QMS and provide a means to reference associated system procedures and programmes, work practices, policies and forms. The quality manual must be established and implemented, and verification activities such as internal audits (see 11.9) must be undertaken to ensure its appropriateness to the processes undertaken and the degree of effectiveness in addressing food safety and quality criteria. The quality manual should be available to all relevant staff. It should integrate fully with the HACCP documentation (and, as appropriate, threat analysis critical control point (TACCP) and vulnerability assessment plans and documentation; see Chapter 6) and define how the organisational structure has been developed to ensure food safety, food integrity and product quality, and continued compliance with defined product and process criteria.

Formal Policies

13.4 Formal policies should be signed by the member of the senior management team with overall responsibility for the safety, legality, integrity and quality of the products manufactured. A quality policy is a statement of the overall mission, intentions and strategic direction of an organisation as related to quality criteria. The quality policy must be documented and approved by senior management. The policy defines the organisation’s intentions and commitment to manufacturing safe and legal products that meet customers’ quality expectations. The organisation must demonstrate that it has communicated its quality policy to all personnel and that they understand the importance of the policy statement and associated QMS.

A food safety policy addresses the food safety intentions and objectives of the business and can be a standalone document or be integrated with the quality policy into a joint statement. Equally the quality manual may be a standalone manual that interfaces with the HACCP plan or a combined food safety and quality manual.

A food integrity policy may be a standalone document or subsumed into an integrated food safety, quality and integrity policy. A food integrity policy statement addresses the intentions of senior management to ensure that there is accountability with regards to products, processes, data and employees’ activities and actions. Quality, safety and integrity objectives should be formalised, that is, documented, time based and measurable, so that achievement can be demonstrated. Policy objectives should be communicated to all staff, whether through the formal policies or other means. Consideration should be given to the reading or language difficulties of staff when these objectives are communicated. Appropriate personnel, at a minimum time frame of annually, should monitor the ongoing progress towards the achievement of food safety, integrity and quality objectives, and the results form an input into the management review process (see Chapter 11).

Delivery/Intake Inspection Records

13.5 Due to the requirements of the supplier and buyer, and the need for inspection records containing certain information along with other recorded data, a separate record is normally required for the inspection of every delivery or part thereof. Copies of this record may go to the vendor, production manager, purchasing manager and quality control manager. This documentation will also play a pivotal role in the case of contract manufacturing (see Chapter 33). Considering the number of times this information is used, it is necessary to make the process convenient and brief, but complete in all the essential details relating to the consignment. This record will also be an important link in effectively managing product identification and traceability (see Chapter 14). Consideration should be given to designing the form that is to be completed in such a way as to remove the need to continually repeat certain information on every entry, for example date, location and units of measurement, or product, that may in some circumstances only need to be stated once on the form, whether completed by hand or electronically. Traceability of raw materials and packaging materials to their initial inspection records is critical within the QMS/FSMS/FIMS to ensure that food safety, integrity and quality criteria have been met. These records will form part of the audit trail in the event of a product withdrawal or recall (see Chapters 11 and 27).

In‐Process/Production and Finished Product Inspection Records

13.6 It is vital that accurate records be maintained of all relevant production data, including actual processing details and performance, and end product quality. These records should be readily available for a predetermined time after the end of the expected shelf life of the product (see 13.10).

The manner in which these records are kept will depend on the requirements and size of the operation and can range from individual worksheets and diaries to full‐scale computer systems. Any mandatory requirements, such as those for UK weights and measures legislation, must be implemented (see 13.10).

13.7 The use of clear concise notations should be ensured and all records made in non‐fade permanent ink. The use of Tippex‐like materials on written documents should not be permitted; any alteration of an entry should be done by strike‐through, accompanied by the corrected entry and initials of the person making the correction. This function should also be available on electronic records. Any amendments that require formal authorisation, for example by the quality control manager, should be appropriately and clearly authorised. Wherever possible, all records should declare the units of measurement and the physical conditions of these measurements. The use of the British Standards Institution (BSI) notation is recommended. Records should, wherever possible, bear details of the target and actual values recorded.

13.8 Personnel completing records should have sufficient training on how to complete the form, and the effectiveness of this training should be assessed routinely. Particular attention should be paid to ensuring that personnel understand the need to fully complete the record. Personnel must be aware that a blank box on the record implies that the inspection or test has not been undertaken, that is, there is no evidence to support it has been undertaken. The quality control manager should ensure that all quality control personnel show consistency in how they complete the records and also assess the use of quantitative rather than semi‐quantitative or qualitative measures of quality criteria. The use of scoring systems or colour‐coding systems (such as a traffic‐light system) for records should be assessed, especially where criteria are being used to provide data to monitor performance against food safety and quality objectives. Terms such as ‘good’, ‘nice’ and ‘ok’ are qualitative and may represent in practice different standards of quality as assessed by individual staff. Appropriate training associated with developing quantitative measures to assess product quality should drive greater consistency between individuals, shifts and processing units (see Chapter 17).

Training of production and quality control personnel should emphasise the importance of completing all records at the time the activity is undertaken for which they are recording the data. Personnel must not fill in a succession of ticks and/or initials at some later convenient time. Records should be designed where possible for actual numbers, code letters or words to be written rather than just a tick or cross. Repetitive ticking of a record can lead to checklist fatigue for the personnel completing the record, and this must be avoided at all costs. It is very important that the individual initials each set of information that (s)/he completes on a record so that in the event of non‐compliance, there is traceability on the records to the particular individual who undertook the task. This will also provide an audit trail to associated training records in order to confirm the training that individual has received and whether it has been appropriate and remains current, that is, that they are competent to undertake the tasks for which they have signed or completed the record. Personnel such as the quality control manager or designate, who are required to countersign or ‘sign off’ quality records, should formally identify whether the countersignature identifies the form has been received and is ready for filing or if the countersignature demonstrates that the information on the record has been independently verified and signed off as accurate and complete.

Master Forms

13.9 The term ‘master form’ here relates to both paper (hard) forms and electronic systems of data collection. To assist in the design and construction of master forms and the data they then contain, whether in paper or electronic format, the following checklist may be of assistance for the quality control manager:

1. Determine the person(s) responsible for developing, designing and setting up the necessary master form(s) and determine the competent personnel who will be undertaking the checks and then completing the record(s). Suitable training must be given to ensure adequate understanding of the role required of inspection personnel and the significance of identifying system or product non‐conformance and the action to be taken.
2. Ensure that results may be recorded easily and there is sufficient space on the master form to adequately record the results of inspections.
3. Ensure that results and data can be transmitted promptly to those personnel who require it.
4. Arrange that results and data can be transmitted to the proper and appropriate personnel and that the recipients are in a position to take action as and when necessary.
5. Ensure there is sufficient space to record preventive and corrective actions taken as a result of inspection.
6. Ensure that re‐inspection activities, if required, can be appropriately recorded.
7. Control charts may frequently be used to replace tabulated forms with the major advantage that the situation may be noted at a glance and not lost within a mass of numerical values. Where appropriate, data logging for automatic control systems should be used (see Chapter 39).
8. Wherever possible case markings, batch numbers, delivery vehicle and container numbers, along with container seal numbers, are all items of information that should be recorded when examining incoming and outgoing goods. All documents, samples and related data should be clearly dated, if necessary with the time, day, month, week number and year. The use of a sequential or consecutive numbering system is to be commended.
9. Ensure that if samples of packaging and labels are going to be attached to the paper forms there is an indication of where they should be attached, the time they were attached, that is, whether quality assurance or quality control processes are adopted, and a mechanism for ensuring that such labels are formally signed off. If the packaging or label information is scanned into an online system there also must be an indication of where this information is stored and how such processes are formally approved and details retained on the electronic system of who formally signed off the packaging or labels as suitable for use.
10. Ensure that master forms are routinely reviewed to ensure that the design of the master form does not impinge on the ease of completion.

Control of Records Procedure

13.10 Not all records may need to be kept after the production period has ended. The QMS/FSMS/FIMS should not require the retention of excessive records and should ensure that a protocol is set up and followed as to how long individual records should be kept, that is, for a defined time period. Special attention should be given to the shelf life of the product and any legal requirements, including the records and their value in the provision of evidence of due diligence. A controlled records list involving an ongoing and continuously monitored system for purging the files of unwanted old data should be adopted. The control of records procedures should identify how records pertaining to the QMS/FSMS/FIMS and ‘one‐up’ ‘one‐down’ traceability are collated, reviewed and verified, and maintained, including storage and retrieval. In the event of a product recall, customer complaint or other incident, it may be required to retrieve records in a short period of time, for example less than 2 hours, less than 4 hours or within a day, and this should be stated within the procedure and tested a minimum of annually as part of the product recall testing process. All records and data should be carefully examined by a responsible person before filing and at the same time screened for any irrelevant data, which should be removed. The retention time for documents and records should be determined by assessing the shelf life of the product or the shelf life of the customer’s product if manufacturing ingredients or the product is suitable for freezing by the consumer. Any alterations to records should be authorised and dated, and justification for the alteration should be recorded (see 13.7).

Document Approval, Amendment and Control Procedure

13.11 A working method should be established and documented to ensure a document approval procedure is in place prior to issue, and only those personnel with the appropriate level of authority have approved the content and authorised the release of the document. This procedure should be in place for both paper‐based and electronic‐only systems.

13.12 A further working method should be established and documented to ensure that all documents, specifications and so on that form part of the formal management system are updated, that any current amendments are maintained and superseded documents are removed from the system, but held on file for a pre‐determined period of time (see 13.10). The reason for any changes or amendments should be recorded so that there is a suitable audit trail in place. An adequate indexing and recall system, including records of amendments, is essential. The use of systems such as master indexes or master logs is recommended as a means to identify the current version of individual documents and master forms which are currently in use. The working method should also include the method of document identification and the system for replacing existing documents when they have been superseded, especially where there are multiple copies in circulation. Documents should remain legible. Care should be taken when photocopying master copies of paper documents to ensure that neither the quality of print is lost over time, nor a portion of the document is ‘lost’ due to incomplete copying, for example the document control information on the bottom of the document is not copied. Attention should be paid to the number of copies of a master copy required so that the numbers reproduced will be used in a timely fashion and will be adequately controlled. This will minimise the potential for obsolete master forms being used to record information when the form has been updated.

13.13 Internal audits should be routinely undertaken to ensure that the appropriate version of documents and master forms are being used (see 11.9).

13.14 Batch and laboratory samples, when stored, should be treated very much in the same way as documentation, records and data, but special emphasis must be placed on recording the physical conditions of storage, for example temperature, humidity and light intensity. All labels should be firmly affixed to the container and be checked to ensure that they are durable for the period of expected life. The date on which they may be discarded should be clearly defined.

13.15 Documents received and retained in electronic format should be adequately controlled to ensure they are not inadvertently deleted or amended. Provision should be made within the procedures to ensure that there is a back‐up procedure in place for all electronic data to minimise the risk of losing data. Fire risk must also be assessed, and contingency plans need to be in place with regard to paper‐only systems such as a fireproof safe for master copies/key documents or Cloud storage etc. (see Chapter 39).