Module 08: Food Safety Documentation and Record-Keeping

Importance of documentation in food safety in manufacturing

The expanding application of the Global Food Safety Initiative (GFSI) and increased documentation requirements as a
result of the Food Safety Modernization Act (FSMA) have highlighted the need for clear, concise, and easy-to-understand
policies, procedures, and records.

There are several key reasons why documentation is essential. Well-written programs help to ensure continuity of best
practices, which in turn, lead to a safe and consistent product. In addition, accurate and complete records will help to
demonstrate compliance with regulatory requirements, company and facility management standards, audit standards,
and customer expectations.

There are several examples where the presence or absence of documentation can impact the food safety effectiveness
of your operation. Try asking yourself if you rely solely on great people or if you have a documented program that can be
referenced when your most highly skilled employees are absent. For example, you may have the cleanest location in the
world thanks to a superior sanitation manager. However, if he or she leaves the company, does the knowledge of how to
maintain that level of excellence leave also? This could be a significant gap that could be narrowed with a well-written
program. Another example is the information needed to encourage continuity from shift to shift and operator to
operator. Creative and innovative employees have a tendency to adjust the equipment or invent shortcuts to improve
the process or make their jobs easier. Capture potential improvements through formal procedures that can be shared
across lines and across shifts.

The documents which has to be maintained includes,

 The quality manual

 All system operating procedures
 Formats for proper maintenance of the procedures- document control, production process, HACCP control and
update, read control, reception, storage, despatch, training, Management, GMP, GHP, Sanitation, Pest control
etc.,
 Raw materials specifications
 Product specifications
 COAs of raw materials and as well as products

Properly updating the documents and maintaining the important records are essential to have a well implemented
FSMS- Food Safety Management System.

Importance of Document Validation and Verification

Food manufacturers must obtain and maintain certain documentation, such as government-generated manufacturing
licenses, required permits, allergen statements, ingredient declarations, GFSI certification, and HACCP.

Securing these documents and validating their authenticity is a complex and expensive process that manufacturers often
bypass. It also makes the verification process less effective as it loses its efficacy.
Types of records and their purposes in manufacturing
Food safety records form an important part of your HACCP food safety program. They are an essential record to support
the implementation of your food safety management system and the application of HACCP Principles.

In this guide, I refer to both records and forms. By way of a quick explanation, a record is really just a form that has been
filled out. In this guide, will find:

 Logs of Temperature Monitoring: From storage units through to cooking equipment, these logs show that food
is stored and prepared under safe conditions. Helping to prevent the growth of harmful bacteria.
 Schedules for Cleaning and Sanitation: Regular cleaning and sanitation are crucial for maintaining a hygienic
environment; these schedules provide a structured approach and proof of adherence to cleanliness standards.
 Documentation of Raw Materials: Documenting details of raw materials, including supplier information, helps
trace the origin of food items, which is critical in case of food-borne illness outbreaks.
 Records of Employee Training: Training records show that staff are educated and updated on food safety
practices, ensuring a knowledgeable team equipped to maintain food safety standards.
 Logs of Customer Complaints and Incident Reports: Logging customer complaints and incidents is vital for
identifying areas of improvement and taking corrective actions to improve food safety.
 Annotations on Invoices: A quick note on an invoice about the temperature when food was received can be
simple, solid proof that it was delivered under safe conditions.
 Visual Documentation (Photos or Video Footage): Visual documentation can offer clear and undeniable proof of
compliance or identification of issues, making them a valuable part of record-keeping.
 Instructions in Verified Written Form: Documented instructions that have been verified help ensure consistent
adherence to food safety protocols.

Food Quality Control refers to the set of guidelines, measures, and procedures implemented by the food industry to
ensure that all food products meet the established quality and safety standards. It encompasses everything from careful
inspection of raw materials, monitoring and controlling the production processes, to rigorous testing of the finished
product.

Maintaining stringent quality control helps minimize risks, prevent foodborne illnesses, and ensure consumer
satisfaction. It is a critical aspect of maintaining the credibility of a food business, and it significantly contributes to public
health and safety.

Goals of Food Quality Control

The primary goals of Food Quality Control are multifold, and they revolve around ensuring product safety, maintaining
consistency, and building consumer trust. Let’s delve deeper into each of these goals:

Ensuring Product Safety

One of the main goals of food quality control is ensuring the safety of food products. This involves implementing
measures to prevent food contamination, whether microbial, chemical, physical, or allergenic. It also includes
monitoring and controlling food processing stages to maintain hygiene and safety standards.

Maintaining Consistency

Consistency in food products is another crucial goal of food quality control. This means that each batch of a particular
product must have the same taste, texture, color, and nutritional value. This consistency helps in enhancing the
consumer experience and maintaining brand loyalty.
Record-keeping requirements in the UK in manufacturing
Data retention is a part of a broader practice of records management, which entails the supervision and administrative
management of hard-copy and electronic records. Proper records management is considered a best practice for any
organization, while it’s mandatory in highly regulated industries.

When it comes to electronic records, here are some general data retention requirements:

 The data should be kept in a secure, reliable and non-editable format.

 The methods of record-keeping need to allow quick access, search and retrieval of digital documents for
compliance and legal purposes.
 The storage space should be reduced through automatic deletions of all the records that no longer need to be
preserved.

In the US, several major industries are strictly regulated, and various government and industry-unique laws and
regulatory bodies (FINRA, SEC, GLBA, SOX, FOIA, FERPA and others) provide guidelines for the retention and disposal of
email and other electronic communication records.

In the UK, there are 2 major data retention laws – the Data Protection Act (DPA)/GDPR and the Freedom of Information
Act. By taking a closer look at these laws, we’ll try to answer the most common questions about data retention
requirements in the UK and whether data archiving is mandatory.

Also keep records to ensure that weekly working time and night work limits (under the Working Time Regulations) are
complied with in your business. It's up to you to determine what records you need to keep for working time purposes,
but you may be able to use existing records maintained for other purposes, such as pay and payroll.

Document control and versioning in manufacturing

One of the important features of a manufacturing system is having control of the documentation that is used to
manufacture the product. This documentation includes every document used in manufacturing.

 Component specification documents

 Custom component drawings (Sheet Metal detail, Machined Part detail, Molded Part detail, etc.)
 PCBA documentation
 Etc.
 Assembly drawings and procedures
 Test procedures
 Checklist forms
 FAT forms (Factory Acceptance Test)
 Manufacturing Process Control documents
 SOP – company standard operating procedures (e.g., ESD Control Plan, Kitting Procedure)
 QMS documents – quality management system
 These documents have a few important features beyond the information they convey:
 Title – to aid in finding the document
 Document Number – a unique code which identifies the document and traces it through the ERP and QMS
systems
 Document Revision – a number or letter designation which identifies the revision of the document.
 Authorizing signature or other indication that the document is approved for manufacturing.

The information in a document is the purpose for the document, but the document’s meta-data, the Document Number
and Revision is what shows that the information about to be used is the exactly correct version of the information. If
there are multiple revisions of an assembly procedure, say, revisions A, B, and C, it is always the latest one (C) that is
used for new production builds. There can be only one version of a document at Rev C. If you must ask if you have the
latest version of the Rev C document, you’re doing it wrong; moreover, calling something the ‘latest version’ can prove
to cause problems in Production. Engineering could be referencing a document that is the ‘latest version’, while
Production has a completely different ‘latest version’ that conveys different information that could impact product.
Revision control aligns all stake holders related to a document.

Developing version control in document control work is essential to manage and track changes made to documents over
time, ensuring that the most current and accurate information is always available. Here are steps to help you establish
version control:

 Define a Versioning System: Decide on a version numbering or naming convention that suits your organization's
needs. Common methods include using numbers (1.0, 1.1, 1.2), letters (A, B, C), or a combination of both (1.0a,
1.0b, 1.1a).
 Create a Master Document Repository: Establish a centralized location where all documents will be stored. This
could be a physical file cabinet or, more commonly, a digital document management system or a cloud-based
platform like SharePoint, Google Drive, or a specialized document control software.
 Document Check-In/Check-Out: Implement a system that allows users to check out a document when they
need to make edits. During this time, the document should be locked for other users to prevent conflicting
changes.
 Revision History: Maintain a log or history of document revisions. This should include the date of each change,
the person responsible, a brief description of the change, and the version number or identifier.
 Access Control: Control who has access to edit or view documents based on their roles and responsibilities. This
is important to ensure that unauthorized changes are not made.

Maintaining accurate production records in manufacturing

Recording quality control procedures is not only a compliance requirement, but also an invaluable asset for optimizing
your plant operations. Keeping accurate records allows you to monitor and confirm the quality of your inputs, processes,
and outputs; detect and correct any errors, defects, or deviations; assess and enhance your efficiency, productivity, and
profitability; prove your compliance with quality standards and customer expectations; assist in decision-making and
problem-solving processes; and offer evidence and feedback for continuous improvement and innovation.

Maintaining accurate production records is crucial in food manufacturing to ensure product quality, traceability,
compliance with regulations, and overall efficiency. Here are some key practices for effectively managing production
records in the food manufacturing industry:

Document Standard Operating Procedures (SOPs):

 Develop detailed SOPs for each step in the production process.

 Clearly outline procedures, measurements, and quality control checks.
 Ensure all employees are trained on and have access to the SOPs.

Use a Comprehensive Record-Keeping System:

 Implement a robust electronic or paper-based record-keeping system.

 Include templates for data entry, production logs, and checklists.
 Ensure the system is user-friendly to encourage compliance.
Incident reporting and investigation in manufacturing
A food incident is when there are concerns about the safety of a food (or animal feed) product and action may need to
be taken to protect consumers.

With food safety-related recalls becoming more commonplace, it is essential for incident response teams to understand
and implement processes that will help manage these events in the most transparent and effective ways possible. How
your company chooses to function in the middle of a crisis, especially during the early stages when communication is
most critical, will undoubtedly affect your entire business going forward.

Incident management may mean different things to different people. As with all discussion points, it is always best to
clarify the meaning of the subject under scrutiny. Therefore, before diving into this subject, here are definitions of the
keywords in this discussion:

Risk : The potential that a chosen action or activity (including the choice of inaction) will lead to a loss (an undesirable
outcome)
Incident : An occurrence of seemingly minor importance that can lead to serious consequences
Crisis : Any event that is, or is expected to lead to, an unstable and dangerous situation affecting an individual, group,
community or whole society
Management : The act of getting people together to accomplish desired goals and objectives using available resources
efficiently and effectively.

Reporting unsafe food

 Must tell the relevant authorities if you think food or animal feed you have is unfit or harmful to health. This also
applies to food or feed that you previously had. The relevant authorities may include:
 Food Standards Agency (FSA) - for food
 Department of Agriculture, Environment and Rural Affairs (DAERA) - for feed
 It may also be a good idea to inform your trade association.

Types of food incidents

'Any event, where, based on the information available, there are concerns about actual or suspected threats to the
safety, quality or integrity of food or animal feed and that could require intervention to protect consumers' interests.

The main categories of incidents are:

 contamination of food or animal feed - during processing, distribution, retail or catering

 incorrect food labelling - such as the omission of allergenic ingredients on a food label
 environmental pollution - such as a fire or chemical or oil spills

The role of electronic record-keeping in manufacturing

Electronic file and document management as records is known as electronic records management, or ERM. Using
automated methods, electronic records management, manages records in any format. The broadest word for
electronically managing documents in a variety of formats—electronic, paper, microform, etc.—is electronic records
management. It ensures streamlined control of documents held in computer systems, and making sure they stay useful
from creation to deletion. The primary distinction between ERM and conventional records management pertaining to
tangible documents is the approach. As a component of a digital business process, ERM records information. It is like the
careful librarian of digital documents in a company. It’s all about keeping the digital files organized and safe from the
moment they’re created until they’re no longer needed.
Digital Records for Manufacturing

So far, most of what we’ve said about the benefits of digital document management could apply to any industry. What
makes managing your files and records electronically so good for manufacturing?

Manufacturers often have to manage complex workflows that rely on multiple suppliers, contractors, and vendors.
There’s plenty of paperwork to go along with all that. Plus, there’s paperwork associated with supply-chain and
inventory management for those workflows. On top of all that, there’s also product distribution, transportation, and
delivery to manage.

Retention and disposal of food safety records in manufacturing

Food safety records form an important part of your HACCP food safety program. They are an essential record to support
the implementation of your food safety management system and the application of HACCP Principles.

In this guide, I refer to both records and forms. By way of a quick explanation, a record is really just a form that has been
filled out. In this guide.

Designing your food safety forms

The key to a great food safety record is in the design. This quote by Samuel Johnson sums my feelings on form design in
a nutshell. The design of your food safety and quality compliance forms can have a real impact on their completion
success rate. The easier it is to fill out a monitoring form the higher the likelihood the form will be completed. If your
form is poorly designed, food handlers will find it hard to complete. This then has an effect on the ability for your
business to provide completed records during an audit.

Form Design considerations

When designing food safety forms, especially those that will be completed by hand, maintain a balance between
readability and aesthetics.

 There should be adequate space to record the required information. Make sure that the monitoring form is not
cramped.
 Text on the monitoring form is a font size that is readable and legible. If you have photocopied forms for use,
make sure you can actually read the printed information.
 Good use of white space around each entry field and the border of the form. Good spacing contributes to better
form completion.
 Ideally, stick to one colour in your form design. Using a dark colour will contribute to better form photocopying.