Tip Sheet 09 - Document Control and Records

The food safety manual, documents and records are the physical evidence of the site’s SQF System. The food safety manual includes the site’s written procedures, pre-requisite programs and any other documents that supports or provides evidence of the development, implementation, maintenance and control of the SQF System.

Documents include policies, procedures and forms that must be controlled so as to be up-to-date and current. Records are evidence of the execution of the food safety plan and include such things as monitoring logs, certificates of analysis and calibration records; these must be current, readily accessible to staff, securely stored, but easily retrievable when necessary.

Learning Objectives

• Document and maintain a food safety manual
• Prepare and control documents
• Maintain and store records

Applicable Code Elements

• 2.2.1
• 2.2.2
• 2.2.3

Key Terms

Food Safety Manual

Written procedures, pre-requisite programs and any other documents that supports or provides evidence of the development, implementation, maintenance and control of the site’s SQF System

Document Control

The manner in which documents are developed, maintained, distributed and/or used.

Records

Documents that provide evidence of results achieved or activities performed.

Register

An official list.

Process Steps

1. The Food Safety Manual
   1. There is no prescribed format for the manual; format is determined by the site.
      1. It can be divided into a separate policy manual, food safety manual, etc. or combined into one manual. It can be integrated with other operational procedures, or housed in a separate SQF manual - the choice depends on what best suits the site’s business.
   2. The main aim is to ensure the manual conforms to the relevant requirements of the SQF Fundamentals Code, and be readily useable by the staff located at the site. It therefore is to be brief, concise and available in a form and language that meets the access needs, language and literacy levels of the operating staff.
      1. It may reside in either paper or electronic form.
2. Document Control
   1. All management system documents (e.g., policies, procedures, specifications, food safety plans, work instructions), and any other operational reference documents (e.g., regulations, customer requirements, equipment instructions, etc.), must be controlled to ensure their currency and relevance.
      1. This includes templates for records that are used to report calibration, monitoring, inspection and audit results.
   2. Documents can be paper-based, stored electronically, or a blend of both. However the current copy of the relevant documents must be available to employees who need to use them.
   3. A list (also known as a register) of documents and any amendments to documents must be maintained to identify the current documents in use.
3. Records
   1. Records collect and retain the information about processing operations recorded on forms, which must be clear, concise, legible and accurate.
   2. Records must be stored so as to not be damaged so they can be retrieved for investigation purposes. Storage can be electronic or paper-based.
   3. Records must be suitably authorized and must be stored as required by the site, customer or legislation.
   4. Electronic records are acceptable. The site must have the means to manage electronic security of records, electronic signatures of monitors and reviewers and the means for electronic review.
   5. On paper-based records, if errors occur, a line through an inaccurate recording, with accurate recording and initials of the monitor is most often used within the industry.
   6. The SQF Code does not prescribe the duration for retention of records. Instead, it may be prescribed by legislation, customer requirements or insurance coverage. Apart from those requirements, the general rule is to retain records for the commercial shelf-life of the product (i.e., the maximum time before consumption). However for short shelf-life products, site must retain records beyond the next recertification audit, as a minimum.

Relevant Resources

• Skipper, Stephanie L. How To Establish A Document Control System For Compliance With ISO 9001:2015, ISO 13485:2016, And FDA Requirements A Comprehensive Guide to Designing a Process-Based Document Control System ASQ Quality Press, 2015
• American Society for Quality
  • http://asq.org/