Part II Appendices3.1.2The food safety and quality manual shall be fully implemented and the manual or relevant
3.2 Document control
The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.
Interpretation
Documents must be effectively controlled to ensure that staff are working with the most up-to-date information and to minimise the potential for mistakes. Documents include policies, procedures, work instructions, records, forms, specifications, data lists and any information that is written down and defined. They may be available on paper (i.e. as hard copy) or in electronic format.
Clause Requirements
3.2.1 The company shall have a procedure to manage documents which form part of the food safety and quality system. This shall include:
• a list of all controlled documents indicating the latest version number
• the method for the identification and authorisation of controlled documents
• a record of the reason for any changes or amendments to documents
• the system for the replacement of existing documents when these are updated.
Where documents are stored in electronic form these shall also be:
• stored securely (e.g. with authorised access, control of amendments, or password protection)
• backed up to prevent loss.
Interpretation Documented management system
The control of all documents within the food safety and quality system (for both external and internal use) is important for several reasons, including:
• the documents are kept up to date
• staff are working with the correct version
• the potential for mistakes caused by multiple versions of a document is minimised.
Therefore all documents in use need to be properly authorised and must be the correct version.
The Standard requires the site to have a documented procedure that describes the method by which documents are controlled and managed. This procedure needs to include instructions on how the following features of the document management system are controlled:
• responsibilities for the management of the system
• list of all controlled documents, indicating the current version number and the allocation of controlled copies of the document (see below)
• identification of controlled documents (e.g. document ID, issue date, version number)
• records of the reason for any change(s) (see below)
• method of rescinding and replacing documents.
In order to demonstrate the control of document issue, it is necessary to maintain a
register of all controlled documents, their allocation and issue status. Where the controlled documents are all contained on an electronic system, it is usual for printed versions to be marked as uncontrolled. Each copy must be authorised (e.g. with a signature or stamp) to show it is for use, and each must be given a version number so that out-of-date documents can be identified and removed. This must be evidenced by the fact that all documents in use are the most up-to-date versions.
Where documents are maintained electronically, the site is required to ensure that they are stored securely and cannot be amended by unauthorised persons; for example, by using individual passwords or security swipe cards. This includes backing them up appropriately to ensure no data is lost. The auditor will ask to see evidence (e.g. a procedure) that the site has an effective backup process, rather than auditing that the backup contains all the relevant files.
Part II Appendic es
Interpretation
continued The methodology or type of electronic storage is not specified. The site may choose to use an internal server to store data; or it may use cloud services, which are generally considered to be secure and backed up, providing there is control of authorised/authenticated users.
When a document is changed, a record needs to be made of the change and the reason for it. This can be achieved by keeping a copy of the previous version with the reason for the change written on it, or by keeping a history of amendments. Consideration should also be given to the most effective method of communicating the changes to staff; for example, by highlighting the change within the new document or training relevant staff.
Further guidance How to put a document control procedure in place
Firstly, ensure there is a single, clear, documented system that operates across all documents within the food safety and quality management system and that it includes the minimum requirements highlighted in the Standard:
• identification of the individual(s) responsible for management of the system (i.e. who is authorised to issue or amend documents). This might be someone with the authority to instigate and maintain the system
• the list of all controlled documents
• methods of identification of controlled documents
• records regarding the reasons for any changes
• the method of collecting and replacing documents.
List of documents
Your site needs a list of all the documents within the food safety and quality system.
Typically this will include:
• the document identification or number. The Standard does not set out how you should identify your documents, but an example format would be using sequentially numbered documents or an initial letter (often representing a department or activity) followed by a number (e.g. P0123); Figure 6 shows an example
• the document title. Use a concise title that clearly explains the purpose or content of the document (e.g. ‘metal detector check procedure’)
• the current issue or version number. Each time the document is updated, amended or replaced, a new version number should be used
• the issue date. Include the date when the current version of the document first came into force
• withdrawal date (if applicable)
• review date (if applicable). Documents may require periodic review to ensure the information remains applicable and up to date
• the allocation of controlled copies (i.e. who has a copy of the document).
Further guidance
continued REFERENCENUMBER TITLE VERSIONNUMBER ISSUEDATE WITHDRAWAL REVIEWDATE ALLOCATEDCOPIES
P101 Metal Detection
Check Procedure
1 1 June
2019
1 January 2020
N/A J Jones
B Brown S Smith
P101 Metal Detection
Check Procedure
2 1 January
2020
N/A J Jones
B Brown S Smith
P102 Product
Check Weight Procedure
1 1 January
2019
N/A S Smith
G Green
Figure 6 Example of a document list
Identification and authorisation of your documents
The simplest way to identify your document is to include a footer on each page that contains the relevant information, as shown in Figure 7. This may include the:
• document reference
• issue or version number
• title of the document
• date of issue
• page number and total number of pages.
REFERENCE: P101 TITLE: METAL DETECTOR CHECK PROCEDURE
Version Number: 2 Page: 1 of 5 Issue Date: 1st January 2020
Acceptance of Raw Materials Version 1 Page 3 of 4 Issued: 1/1/20
G001
Figure 7 Typical formats for footers
You will need to include a method of authorisation too (e.g. a signature or a stamp that identifies genuine copies of the document). Where these are held electronically, it may be more convenient to label printed copies as uncontrolled copies.
Making changes to your documents
When a document is changed, you will need to make a note of the change and the reason for it. You can do this by:
• keeping a copy of the previous version with the reason for the change written on it, or
• keeping a ‘history of amendments’ log within each document; Figure 8 shows an example.
Part II Appendic es
Further guidance continued
New metal detector purchased which needed to be reflected in this procedure
DATE CHANGES
1 Jan 21
28 Sept 21 Frequency of checks updated to reflect requirements of a new customer
Figure 8 Example of an amendments log
A new issue or revision always replaces an existing document. You must not have two different issues or revisions of the same document at any time.
You will also need to ensure that any policy or procedure changes are communicated to the relevant staff. This can be done by highlighting the change within the new document or by specific training prior to the issue of the new version.
Replacing your documents
You will need to keep a record of all controlled documents and their allocation. This will mean that whenever a document is updated or replaced, the person responsible can ensure each old copy is returned when the new version is issued. The easiest way to do this is by using a sign-off sheet where staff sign to indicate that they have returned the previous version and collected the new one.