Developing, documenting, implementing, and maintaining the necessary documentation to properly maintain a food safety management system (FSMS) is an integral part of doing business for food processors, ingredient manufacturers, and packaging suppliers large and small. Yes, even the very small operator who might not be mandated to have such programs will, in all likelihood, be asked to show it has a food safety system in place for its customers. The bottom line is fairly simple: Without a FSMS, a business will suffer and might even vanish. The expectation is each and every operation shall have a fully documented system that includes procedures, work instructions, and the necessary recordkeeping forms for all elements of the food safety plan.
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Creating procedures and implementing them is not easy nor is it something that can be accomplished overnight. As an example, a company may have what it considers to be a well-documented FSMS, but updating that system to meet the requirements of one of the Global Food Safety Initiative management schemes or the ISO 22000 food safety standard could take 12-18 months (see Table 1). For a small company or startup that is developing everything from scratch, this is probably an unrealistic timeline. Why? The equation for building your program was highlighted above: development, documentation, implementation, and maintenance. Implementation includes the training element, which must be properly documented. This takes time, commitment, and lots of work. So, what can be done to help meet these challenges?
Meeting Challenges Head On
First and foremost, management must be committed to the project, which includes providing the necessary resources and support to get the work done. Management must also be patient since the work is not going to be completed overnight. The following steps will help overcome documentation challenges.
- Appoint a document control officer.
- Develop a standard format for procedures and work instructions.
- Create a master list of the programs that need to be documented.
- Develop a plan for developing these programs.
- Assign responsibility for developing protocols.
- Create the procedures.
Hiring or appointing a document control officer should be a task for top management and one that the food safety or quality manager needs to emphasize the importance of. Be cognizant of the fact that this would be a permanent appointment, not a temporary position while building the program. Document management will remain an ongoing task throughout the development process. The document control officer’s role is not to write the procedures but to manage the process of developing the necessary documents. He or she could be the quality manager, but that need not be the case. The document control officer could be someone from IT, but above all, must be someone who is organized and has computer skills. The document control officer should be responsible for:
- Ensuring all procedures and work instructions are created using the standard format;
- Ensuring documents are created by approved persons;
- Assuring that all new documents are reviewed and edited as needed;
- Tracking changes to existing documents;
- Tracking non-controlled documents;
- Maintaining a master log of all documents and records;
- Ensuring all new protocols and revisions have been properly reviewed and approved;
- Controlling distribution of new and/or revised documents and maintaining a record of distribution; and
- Collecting and destroying old documents and forms.
This is an ongoing task and not one that should be eliminated once the program is up and running.
Food processors need to create a standard form to be used for all procedures and work instructions. Table 2 is an example of what might be adopted. The standard should also include either a header or footer to indicate the procedure number, the date it was adopted, who created the document, and whether it is an original document or has been revised. One element many processors fail to do when developing procedures is include corrective actions. If product safety is potentially compromised, the corrective action needs to address how that product will be handled. For example, calibration is an essential program for ensuring that monitoring devices are working properly. If an instrument such as a temperature monitoring device is found to be out-of-calibration, there is a chance product safety was compromised. The calibration procedure must address that concern.
Operators must create a master list of all the procedures and work instructions that need to be created. The FSMS needs to include protocols for the Hazard Analysis ad Critical Control Point (HACCP) plan, the supporting prerequisite programs, food defense, and more. For a partial list of what a processor might need to develop, see the List of Procedures to be Developed box. There will also be programs in which different levels of procedures will exist. The primary example is cleaning and sanitation program. This program would include general procedures that describe the expectations of the program, define the master cleaning schedule, and establish a means to both validate that cleaning procedures are effective and verify that the work was done properly. The cleaning program would also include specific work instructions that defined how each piece of equipment and each area/part (floors, walls, drains, overheads, etc.) of the plant would be cleaned.
The next step is to create a plan for developing and documenting each of the procedures defined above. The schedule highlighted in Table 1 could serve as a model. Ideally, when this plan is created, priorities and scheduling should be developed based on risk. When developing the implementation plan, the team should assign responsibility to specific persons within the company to develop and document each element on the master list. If a person has been doing a task, he or she would be the logical choice to be assigned the task of developing the procedures for that area. A word of warning: It is a bad idea to hire someone from the outside to create a company’s HACCP plan or write the supporting procedures. For a program to be successful, it is imperative the company have a sense of ownership of those procedures. If a third party writes them, there is no ownership, which is a precursor to failure. Consultants should be advisors or facilitators, not creators.
Which brings us to the last step: developing and documenting the individual procedures. This can be a real challenge for companies since there are many who are not comfortable when it comes to writing or sitting in front of a computer. There are ways around this. One is give the person assigned with creating the protocols a voice recorder to talk through the protocols. The procedures on the recorder can then be typed up and edited by someone within the company.
Getting things on paper is only part of the whole equation. Remember the mantra from the start of this piece; develop, document, implement, and maintain. There is always an issue with creating procedures. Are they well-written and will they be easily understood by those responsible for conducting the work? One means for ensuring this is to run draft procedures by non-technical types. If they can grasp what is wanted, there is a very good chance the procedures will be acceptable and easily understood by those who will do the work.
Don’t forget, procedures, work instructions, and recordkeeping forms are constantly evolving. They will be upgraded, updated, modified to meet changing demands, and developed anew as operations expand and seek to do things better. This is one reason why appointing a document control officer was the first step in this procedure. Their task or tasks won’t go away.
Stier, industry editor for Food Quality & Safety magazine, is a consulting food scientist with international experience in HACCP, plant sanitation, quality systems, process optimization, GMP compliance, and food microbiology. Reach him at firstname.lastname@example.org.