Documenting and Organizing Food Safety and Quality Programs

Document, document, document! If it is not documented, it is not done.

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.

In addition to the need for comprehensive and user-friendly procedures, well-maintained records are also required for internal and external purposes. The goal of record keeping is to provide a set of records that reflects the actions taken and the existing conditions. Ideally, those actions and conditions are in line with program expectations. High-quality records include routine and non-standard activities. An example of a non-standard activity record might be an unscheduled line shutdown, reason the shutdown occurred, and corrective and preventive actions that were taken.

Reliable records can be used to track and trend information to determine means of continuous improvement. Historic information is vital for conducting a root-cause investigation and identifying a failure or inadequacy with the product or the system. Tracking information is not only necessary to investigate a failure, but also to identify success. If you do not know or understand the conditions that led to a successful outcome, it will be difficult to repeat those same conditions.
 

Practical definitions

The differences between policies, programs, procedures, and records are commonly misunderstood. These practical definitions should clear up some of the confusion:

• Policies are sweeping, general statements that outline philosophies or general goals. An example of a policy is a quality mission statement, which, at its core, states that you will manufacture safe and legal products.
• Programs are the entire combined effort to achieve a goal. It includes all documentation, training and education, and actual practices.
• Procedures are the instructions for doing an activity.
• Records are real-time notations of activities and measurements. Forms are the documents that are created for recording activities.
  
   

Best Practices

One crucial aspect of successful documentation is to ensure all documents are designed for the user. The key characteristics should be that the procedures are written clearly and concisely and that they are user friendly. Consider how an employee will use the procedure to learn a new task. There is often a delicate balance between having enough detail, and keeping it to the point. User-friendly procedures also clearly distinguish between separate ideas and activities. Procedures must be in a language that is clearly understood by all employees. Photographs are a very effective way to communicate exact procedures and expectations.

Well-designed forms include sufficient room for the resulting information, signature, date, and time. There may even be references on the form to procedures or other instructions related to taking measurements or responding to out-of-tolerance results. Typically, the best forms are designed with user input.
 

Organizing Documentation

Policies and procedures are typically organized into manuals. These can be paper-based or electronic. Using a manual system will help to keep your materials organized. Overarching policies and procedures are typically maintained in a master quality manual and impact multiple departments. Examples of overarching procedures include hold and release, raw material and finished product traceability, label development and review, etc.

Separate manuals are developed for department-specific procedures and activities. Department-specific manuals may include sanitation, integrated pest management, preventive maintenance, HACCP, laboratory procedures, etc.

Each manual, whether overarching or department-specific, should contain a table of contents that lists the name of each document, its corresponding alphanumeric document control code, and the most recent revision date. Documents that are well-organized are more likely to be used and, therefore, increase the chances for food safety and quality success.
 

Formatting Documentation

Effective and reliable documents include document-control information on each page. This information is typically in the document header or footer. Critical information to include is: document name, alphanumeric code for the document, revision date, page number, and total number of pages. Document control information also should include the name and title of the document author and the name, title, and signature of the person who approved the document.

Available and readily useable documentation of policies, procedures, and associated forms are necessary to ensure your company’s expert knowledge is retained, to promote continuity of doing the desired task with the same method, and to be able to recreate the conditions of the plant when the product was being made.

Customers, audit standards, and regulatory bodies are requiring more documentation so that you can prove you actually have a program and that you are following the policies, procedures, and instructions.

The author is Food Safety Professional, AIB International.