General Requirements

At this time in our food chain, there are many reasons why a company may choose to develop, implement, and maintain a system compliant with one of the Global Food Safety Initiative approved, benchmarked approved food safety schemes. Of course, one of the most recent drivers is the pressure being applied by major customers.  However, the decision to move forward must be a decision not only because customers or regulators are forcing or encouraging the move, but also because it makes good business sense for the organization. A well-defined, managed, and compliant system adds value and reduces overall costs for the organization.

Actual cost figures are tough to identify. It is difficult to measure the savings of something that did not happen?  However, there are enough companies with recalls, incidents, and ruined reputations for management to fill in the blanks, understanding what could happen and might very well happen if the organization does not take control and focus on preventing issues rather than addressing issues after a crisis. In the past, we learned from our mistakes. In modern times, we cannot afford to learn from our mistakes; we must avoid these mistakes by being proactive. The structure and discipline provided by an effective food safety management system does not guarantee food safety, but it absolutely provides the foundation for a proactive process to ensure that many mistakes can be avoided and prevented.

This type of system requires a team effort that is not only supported by top management, but also empowers and trains all associates to understand and play a significant part in food safety every day. Food safety affects everyone; each person has a role no matter what his/her area of responsibility includes. 

The optimum food safety management system

“The optimum food safety management system is one that reduces risk through systematic reduction of variation. The benefits of a healthy food safety management system include minimized food risks, stronger relationships with other links in the food chain, and a clear message about your proactive approach to food safety.” (Link, An ISO 22000:2005 Pocket Guide for Every Employee.  C2008. Quality Pursuit, Inc. Pg 6).

The effective food management system must be defined and implemented in a manner that ensures that all activities that impact food safety are defined. The structure of the food safety management system must fit the needs of the company. Although the food safety standards do have most of the requirements in common, there are definitely some specific requirements, depending on the focus of the chosen standard. It is important for management to understand that second only to the production of a safe product, is the assurance that the requirements are integrated into the system, limiting re-engineering of the process for the standard. There are some very specific requirements that must be met; however, even among these, a requirement may not relate to the organization’s operation or the operation may have mitigated the risks which have eliminated the hazard or reduced it to an acceptable level. Mitigation and risk assessment is discussed in more detail in chapter 15.5. 

Management system scope

When thinking about defining, implementing, and maintaining a system compliant with any standard, it is very important to understand not only the focus of the standard, but also the scope of the standard reflected by the organization’s management system. Many times, when working with a company, defining the scope of the system often becomes a struggle for top management. Basically, the requirement is very straightforward; how should the requirements of the standard be applied to the system? The main result must be an effective food safety management system that incorporates change management and continuous improvement processes that are not only effective, but also meet the requirements of the standard of choice.

The scope connecting the company with the requirements of the food safety standard of choice must be clearly defined and meet the requirements of the standard.  ISO 22000:2005 Section 4.1 has very specific requirements related to defining the scope of the system. These include, but are not limited to specifying “the products or product categories, processes, and production sites that are addressed by the food safety management system”. SQF edition7 describes the “scope as the food sector categories and products processed and handled by the site.”

General requirements for compliance

ISO 22000:2005 Section 4.1 is basically a summary of the entire standard. Titled “General Requirements”, it states that the basic requirements for compliance must ensure that all food safety hazards that are reasonably expected to occur are identified, evaluated, and controlled in such a manner as to not directly or indirectly, harm the consumer. A process is defined and implemented so that food safety related product information could be (and is, when needed) communicated throughout the “food chain”. If the organization has an issue with food safety, is there a process in place to communicate this in an effective manner that prevents any harm to the consumer? Communication is stressed both internally (within the organization) and externally. External communication means throughout the food chain that includes the suppliers, customers, and consumer (chapter 3).  A customer may be the same as the consumer; however, a customer may also be a broker or a large chain that purchases directly from the organization and then sells to the consumer.

Each of the food safety management standards either require a formalized food safety manual (top level manual) or a formalized process for documentation that identifies and links to system documentation and records required for the food safety program. The Global Food Safety Initiative (GFSI) guidelines does require a top level manual thus as discussed in chapter 1, in order for a scheme to be approved by GFSI it must meet the requirements of its guidelines.  

The advantages of such a food safety manual (i.e. top level manual) that answers the requirements of the specific standard are many. When the standard says “shall”, then the top level food safety manual answers as to how this is being done specifically for the organization’s system or it references the documentation that does define this. It is highly recommended that the organization creates a food safety manual that is clearly links to the requirements of the chosen standard and where ever possible defines the organization’s response to the defined requirements of the chosen standard. This provides an excellent foundation and in as many opportunities as possible may relieve the necessity to have extra documents (chapter 6).

Example one: The standard states “the organization shall provide the resources for the establishment, management, and maintenance of the work environment”.  The food safety manual answers this “shall” statement specifically for this operation by stating that “Top management assesses and ensures that the food safety management system has the necessary resources through several means, such as management review meetings, daily shift meetings, project planning meetings, staff meetings, and internal audits.” 

Example two: ISO 22000:2005 Section 5.8.1 states that “top management shall review the organization’s food safety management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.”  The food safety manual’s response would be that “top management reviews this food safety management system at a minimum of quarterly through the management review process to ensure its continuing suitability, adequacy, and effectiveness.

Example three: Related to the same reference as example two, the food safety manual may state that “top management reviews this food safety management system at planned intervals as defined in the procedure for Management Responsibility (chapter 3). Keep in mind that a theme that will be emphasized throughout this text is to never define the same thing in more than one document or section of a document. If the topic is referenced, then state “according to” and send the reader to the document or section where this is defined.

Example four: SQF Code edition 7 clause 2.1.3 requires that a Food Safety Manual be documented and maintained by the organization. The manual must include:  (a) a summary of the organization’s food safety policies and the methods it will apply to meet the requirements of the standard; (b) the policy statement and organizational chart; (c) the scope of the certification; and (d) a list of products covered under the certification. Additionally, the manual shall include references to the written procedures, prerequisite programs, food safety plan, and other relevant documentation.  (Note:  Above information was taken from the standard which is under copyright by the Food Marketing Institute.)

Review additional information related to document control in chapter 6. 

The management system manual

If an organization has established multiple management systems (i.e., quality, food safety, environmental, etc.), then it is strongly recommended that a “management system manual” be created that incorporates or better stated, translates the requirements of the standards (integrates the complete requirements) into the organization’s processes.  

Top management and management commitment

As we proceed through understanding, defining, implementing, and maintaining an effective management system, a central theme will be top management commitment. Top management is defined as management ultimately responsible for the system. This may be one person such as the president or the general manager, or it could be the top position and those who answer directly to them (i.e., staff). Defining top management and management responsibility is discussed in more detail in chapter 3. No matter which standard is chosen,  it is critical to continually focus on the fact that top management of an organization must not only demonstrate a strong commitment to the implementation and management of this system, but also to the resource needs of the management system (chapter 3).

Hind sight is 20-20 and it is always a great learning opportunity to discuss the experiences, challenges, victories, and the “if we had only done this” comments shared by system implementation associates once the system has been established and implemented. Guido Abreu, Quality System Analyst for Dosal Tobacco Corporation shared that it would have been beneficial to have had a “simple ISO orientation for the non-QMS professional, focusing on the different levels throughout the organization.” This is a frequent statement and sometimes is based on the organization not having competent management system compliance training through the initial defining phase. It is very important to plan the journey or experience the “challenges” cause from lack of or ineffective planning.  Journeys of any scope are much more enjoyable and less stressful when effective planning prior to the journey is performed. A related example may be to leave on a road trip without planning the stops such that when every one is exhausted and ready to stop due to lack of planning, either there are not any or all hotels are full.   Mr. Abreu, in looking back, commented that “taking more time to plan and perform process flow analysis would have minimized the amount of documents produced. As the system began to materialize and mature, we learned quickly that a major continuous improvement project would focus on reviewing the current documents, revising and reducing to enhance their focus and overall effectiveness.”

Controlled processes 

“The key enabler for food safety is control. For this reason, it is appropriate to briefly elaborate on controlled processes. A controlled process is work conducted in predetermined order and applied at specified levels, resulting in the consistent achievement of the desired outcome. Maintaining the order of the process steps and controlling the process parameters, minimize the variation of outcomes. If the order of work to be done and the level at which it is applied are left undefined, each individual will do their best, but not necessarily use the same process on the same job each time. The outcomes of such efforts will vary widely. In other words, following an established process will provide better overall results than the overall results of individuals putting forth their best efforts. This is why Dr. Deming reminds us that “Doing our best is not always good enough.” (Link, An ISO 22000:2005 Pocket Guide for Every Employee.  C2008. Quality Pursuit, Inc. Pg 6)

Systems Approach for Management

The “systems” approach to management is a central theme when discussing effective management systems. Dr. John Surak describes the following: 

“The standard recognizes that processes do not operate in isolation. The output of one process usually becomes an input into another process (Fig. 34.3). These processes link together to form a system. Therefore, if a company is to be effective and efficient in meeting its goals, the company must manage all of the processes as a system rather than trying to manage each process individually.  ( “International Organization for standardization ISO 9000 and related standards”  Schmidt, Ron and Rodrick , Gary. The Food Safety Handbook,  Wiley (2001)  Page 707)

A summary of the key points of this chapter follows:

• Each organization must evaluate the standards and choose the one that makes the best sense for its operation and products.
• Although initial interest may focus on customer pressure to develop and become certified to a third party type food safety management standard, the value to the company overall does become evident.
• The structure and discipline provided by an effective food safety management system does not guarantee food safety, but it absolutely provides the foundation for a proactive process to ensure that many mistakes can be avoided and prevented.
• Positive, on-going management commitment is critical to the ultimate success and effectiveness of the food safety management system. 

 

Examples of common findings/nonconformances identified based on these requirements:

System findings that are identified or linked to the overall system are rare, but may be identified if the total overall system has not been established.  In some instances, a system finding can be a result of several findings related to several elements.  Individually, the findings may not be significant, but together indicate a breakdown of the total system.  Findings related to the overall system would be graded as a major nonconformance almost 100% of the time.  The following are examples of findings that could be reported against the system as a whole: 

• It could not be confirmed through review of objective evidence that this organization had implemented a management system that was compliant to the current version of the chosen standard.  
• Evidence at this time was not available to confirm that requirements as stated in “blank” standard had been implemented and in compliance.
• Findings during this evaluation indicated that the organization did not have a system compliant to the requirements of the chosen standard.

From Debby Newslow's new book: Food Safety Management Programs: Applications, Best Practices, and Compliance. Chapter 2 "General Requirements"Pages 21-25. c2014 CRC Press. Boca Raton, FL.