As an executive, you want to assure that you get the most for your money in terms of a quality management system that will work appropriately and meet regulatory requirements. But more importantly, you want a system that manages risks and assures that you are producing safe products and protecting public health. These are not necessarily the goals of your risk management staff. They are focusing on risk management in their area of expertise and not necessarily on the entire operation.
ISO 14971 references several tools that are commonly used in the medical device and other industries. Your risk management staff, or consultant, usually implements a tool they have used or perhaps is the newest rage in the news. However, this method is not the best way to select a risk management tool.
Hazard Analysis and Critical Control Points (HACCP) is a system that has been in use since the 1960s as a risk management tool, but its primary exposure to industry has been in the form of a regulatory and inspectional tool. Industries required to use HACCP saw this as something that they had to implement to meet regulatory obligations and missed its real value as a risk management tool.
HACCP – not for foods only
Since HACCP’s birth was in the food industry, it has largely been ignored by the drug and device industries. Misconceptions include that HACCP is for foods and that it requires a regulatory and inspection component to be attached. Neither of these ideas is true. HACCP can effectively be used across many different industries to improve the safety and quality of a product, without a regulatory component.
While the goal of HACCP is to improve the safety of a product, the tool can be used as the backbone for a comprehensive Quality Management System. This is especially helpful to small manufacturers with limited resources. When implemented and followed correctly, HACCP will help assure safe products; therefore regulatory quality management requirements can easily be added to support the HACCP system. Even though HACCP is product-, process- and facility-specific, it is also helpful for consistent management practices in large organizations with multiple manufacturing sites. The basic HACCP system will be consistent and the regulatory requirements for the specific country of manufacturer can easily be integrated. By using HACCP as the backbone, the manufacturer will be assured a safe product is being produced throughout their organization.
But how can something developed at the corporate level be used and understood at various sites, potentially in different countries, having different culture, and speaking different languages? HACCP addresses this issue as it has a different cultural mindset than many industries are currently using. HACCP relates down to the individual performing a task in the manufacturing operation. A team approach is utilized and the training of the employees in HACCP methods gives each team member ownership into the system. Employees realize their importance in producing a safe product. It is not just another document from management, but a living document that must be followed on a daily basis.
A complete management system
While HACCP is a risk management tool when implemented properly, it is also a complete system of management. I like to call it a HACCP Management System. It is a system that is used for the entire life of the product. HACCP identifies the hazards associated with the product from the conception and design phase throughout production and finally in the distribution chain and end of product life. Total Product Life Cycle is the term commonly used; however, this very concept is embedded in the HACCP system. These elements combine to make HACCP one of the most useful and powerful tools available to industry.
Many firms base their device history record (process traveler) around the HACCP Plan Form developed during the implementation process. The HACCP Plan Form can also be modified to meet any regulatory requirements or industry standards or norms. The basic information at a process step can be displayed for the worker as a constant reminder to meet the established limits. This can usually be done as a graph or display so that the operator understands the requirement. Having such a visual aid may be especially important with manufacturing expanding into countries where language may be a barrier, or where employees may be immigrants and not read or speak the native language.
As referenced earlier, HACCP is effective because its development and implementation involves input from each level within the organization–from the assembly line workers or operators to the design and industrial engineers. While the design engineers should be able to identify the hazards in the product, and the industrial engineers the potential hazards in production, the assembly line workers understand their processes in detail and where they have problems and potential hazards on a daily basis. By becoming part of the HACCP team, the assembly line workers provide valuable input into the process, identify hazards that may have not been anticipated during design, as well as identify mitigation steps and corrective actions if there is a process failure. This gives them ownership into the HACCP system and helps them understand how the manufacturing hazards can cause device failure and potential patient or user injury.
Simplicity, its strength
Also, the HACCP system, unlike some other frequently used risk management tools, is simple enough that it does not require development by engineers and other experts. HACCP can usually be developed in-house with proper training and outside experts can be brought in as needed. Thus, by using this tool, cost savings to the organization can be recognized, employees buy in to the program, and safe products are assured. This may in itself be a cost savings for the organization.
HACCP is also useful in internal audits and vendor audits. Its structure identifies areas that should be of major concern to the auditors and thus they are able to concentrate on the elements related to the safety of the product, component, or process being audited. Also, some have found that by implementing HACCP, they have better process control and are able to move away from testing. These changes, requiring fewer personnel resources as well as fewer laboratory tests, result in cost savings.
HACCP also identifies all potential hazards in the manufacturing process and where other appropriate regulations (OSHA and EPA for example) that affect the operation may be integrated into a HACCP Management System. For example, if a hazardous material is used as part of production, it should be identified as a potential hazard in the HACCP plan and the appropriate regulatory citation referenced. These referenced regulatory requirements must be met to safely store, use, and dispose of any hazardous material even if audited by different entities. This may also link to a firm’s Environmental Management System, ISO 14001.
So, in closing, why not take a risk and try this worthwhile management tool? Based on information from various firms who have implemented HACCP, the benefits will be well worth the costs. HACCP is a system that is relatively easy to understand and implement, works great when properly implemented and maintained, and is easy to update and change when appropriate.
In future articles I will address the various principles of HACCP.
About the Author:
CAPT Joseph L. Salyer, RS, MPH, is Consumer Safety Officer at the Center for Devices and Radiological Health at Food and Drug Administration. He can be contacted at Joseph.Salyer@fda.hhs.gov. He is also an Adjunct Professor with Virginia Tech's Center for Applied Health Sciences and the Training Coordinator for the Global Risk Management Alliance, a non-profit educational organization.
