Contents of a Good HACCP Plan & Manual

Basic food safety principles applied in food processing and handling are no longer enough for the modern day customer. Industry standards have far surpassed regulatory requirements. There are several reasons behind the demand of increasing levels of food safety efficacy systems. The most important: ‘consumers’ health is never compromised by consuming adequate food.” When achieving food safety in a product there are only positive outcomes, such as assuring part of business continuity and regulatory compliance, brand protection and customer trust. In order to assure food safety, a methodology that can greatly contribute through documentation, implementation, and maintenance the HACCP Plan (Hazard Analysis Critical Control Points).

All elements of HACCP should be set in consecutive flow so that when consulted or reviewed, everything is aligned to the methodology.

The first element in a HACCP plan is a document where all the names of the HACCP Team members are written and signed, and the team leader is clearly appointed. A brief description of each member’s current position, expertise and experience should be included. A copy of a HACCP formal training certificate of at least one team member should be included. The more knowledgeable the team, the better plan will result.

The second item in the plan and manual should be a full description of the product or family of products within the scope of the plan. The description should include the recipe or formulation, when applicable. The packing materials should also be described as well as the conditions in which the product is to be stored (e.g. temperature, light, humidity) and the length of shelf life. In the description, methods of distribution should be addressed, too; taking into consideration the potential abuse in the distribution chain as well as on behalf of the consumers. The more you know your product, the better you can protect it.

The third component in the plan ought to be the identification of the intended use and consumers. Identification of the intended use must be based on the “usual” consumption of the commodity by the final consumer or user. The identification of consumers shall be based on the targeted consumer. It could be just a segment of the population, such as diabetic individuals, the elderly, infants, individuals allergic or intolerant to a certain food, immunologically compromised people, etc. The more you know your consumers, the better care you can take of them.

The forth constituent in the plan must be the flow diagram. The diagram has to be clear and in enough detail to provide a simple description of the process steps. This diagram is very helpful to the team for future tasks and to others (e.g. customers, auditors, consultants, regulatory officials). Adding some process parameters (e.g. temperature, time, etc.) for each step could be useful, too. The flow diagram must comprehend every process step which is in direct control of the facility manufacturing the food, from the very beginning (e.g. receiving and preparing ingredients, storing packing materials, etc.) to the very end (shipping, storing, etc.) Using engineering drawing is not recommended. The friendlier the diagram is to the viewer, the easier to understand the process.

The fifth element in the plan should be proof that the HACCP Team has verified the flow diagram. This could be the first version of the diagram where notes have been taken and changes made, initialized and dated by the participants. Proof of the verification could also be minutes of the verification process and changes made to the original. The new verified diagram must be available. When no inaccuracies were detected in the original diagram by the verification process, a signed and dated note stating that fact shall be available. The more accurate the diagram, the more useful it’ll be.

The sixth part of the plan must be the documented hazard analysis. This document must make evident the hazard significance assessment based on likelihood vs. severity. The consideration of a hazard being significant or not shall be supported by a justification. Non-significant hazards are not expected to be further considered. However, each hazard (physical, chemical or biological) found to be significant must have a linked preventive measure (e.g. GMPs, a prerequisite program) specific for its control. In the hazard analysis, it is expected to state the specific and actual hazard; and not the cause or the source of it (e.g. Salmonella, glass, sodium benzoate, etc.) The sequence of the analyzed steps has to be the same as that of the verified flow diagram. The more preventive measures, the fewer CCP may be determined.

The seventh portion of the plan should contain documents evidencing the CCP determination process. In this document, all hazards found to be significant have to be addressed. The method used for CCPs determinations shall be available, too (e.g. decision tree, questioner, etc.) CCPs found have to be documented.

The eighth section of the plan should contain the critical limits that were determined for each particular CCP. All the variables, values and units have to be clearly defined; for both lower and upper limits, when applicable. Documents related to the process and relevant sources used to establish the critical limits shall be available to support the limits. These documents could be regulatory standards, guidelines, internal or third party validation, experimental results, literature surveys or experts. The stricter the validated limits, the grater efficacy can be achieved.

The ninth segment of the plan should comprise of documents regarding the monitoring method for each critical limit. The monitoring procedure should contain the following: what is to be monitored? How often it shall be monitored? Who is responsible for performing the task? What instruments are to be used? How is to be monitored? The clearer the instructions are the fewer chances of failure.

The tenth element in the plan should be the corrective actions strategy. Each CCP should have predetermined and documented corrective actions for deviations that may occur. The corrective actions plan should comprise at least the following elements: the responsibility for each action, disposition of the non-complying product, the correction of the cause of failure and recording the event. Records of events should be kept readily available. The more preparation, the less improvisation.

The eleventh component of the plan should be the HACCP Plan verification procedures. These procedures should be content activities designed to confirm that the plan is effective and properly maintained. Responsibility and frequency shall be defined. Some of the following elements should be part of the verification process: description of auditing methods, product sampling and testing, trending analysis, reviewing records and reviewing the whole plan. The more exhaustive the verification is the grater the confidence.

The twelfth module of the plan should comprehend the record keeping and documentation system. In this section it should respond to the following questions? How the system is to be documented? What is to be included? Who is responsible for doing it? For how long are records to be kept? Where are they going to be kept? Who is to have access to what documents and how are those to be controlled?

A more documented plan helps with better execution.

As you may realize by now, developing and documenting an effective HACCP plan is not an easy task. Training on the methodology, experience and technical aspects are essential elements for developing and implementing an effective HACCP Plan. External help and consultation is often required in order to succeed in this endeavor. In such case, DFA  has the right people with the right knowledge and expertise to assist both members and non-members. At DFA of California we provide a recognized HACCP training, consulting and verification services.