The water related certification programs at NSF International are certainly closely linked. Much of the credibility of the Bottled Water, Drinking Water Treatment Unit, Water Additives and Plastics/Plumbing programs relates to and builds on our expertise in each of the other programs. Drinking water treatment especially has been closely related to the bottled water certification and bottled water producer trade association audit programs. Virtually all bottled water has some sort of treatment, from simple sediment filtration of spring water to multi-stage, complex processing of purified water products.
The treatment equipment and water processing have, of course, always been a part of the certification inspections for bottled water. Remember that bottled water is a food and since the early days of food regulation and inspections, the audits have been reactionary by nature. The inspector goes into a food processing (water bottling) plant and documents what is wrong. In this traditional “floors, walls and ceiling” audit the equipment assessment was mostly related to construction and materials, cleanliness and installation of a piece of equipment. A bottled water plant audit may point out the fact that the reverse osmosis system is installed directly on the floor and against the wall so it is difficult to clean the area around it. The drains from equipment may be hard plumbed to sewer lines instead of allowing an air gap when needed. There may be lack of adequate back flow prevention. There may not be proof that a sediment filter was made of food grade materials. In the NSF bottled water certification audit program and the bottled water producer trade association audit programs, this type of audit was the standard until the early 1990s when monitoring the effectiveness of the water treatment equipment was added to the criteria. This was the beginning of the process assessment – based largely on Hazard Analysis and Critical Control Point (HACCP) concepts and terminology.
The advent of HAACP
HACCP is a process-driven food safety system. HACCP was initially developed by Pillsbury and NASA in the late 1950s and was officially named and had its first corporate level acceptance in the 1970s. Two decades later, HACCP had become a widely accepted international standard for food safety. In 2001, a HACCP audit format was adopted by the International Bottled Water Association (IBWA) for the member audits and NSF bottled water inspection program added the HACCP dynamic as well, bringing HACCP to the major North American bottled water producers well ahead of any regulatory requirement to do so (see timeline).
The HACCP system uses a team from each manufacturing facility to identify real and specific hazards. The most effective HACCP team is comprised of employees from the manufacturing facility who are intimately familiar with the bottling process and can therefore identify potential hazards. Once all potential hazards are assessed, the identified hazards, coupled with a likelihood of occurrence become the heart of the HACCP system. Hazards are often similar plant to plant, but with each individual processing system, and water source comes the potential for new and varied hazards in each facility.
After identifying the hazards, the team then examines the controls in-place for those hazards. If those controls eliminate the hazard or reduce it to an acceptable level, it can become a Critical Control Point (CCP). If, by chance, there is no current control in place for the hazard, a CCP must be developed. The rest of the HACCP plan would include monitoring the CCP, corrective action plans for if and when the CCP limits are breached, documentation of all HACCP steps and the implementation of steps to periodically review the plan and verify its effectiveness.
During an audit the HACCP plan is reviewed and the documentation and design assessed by the auditor to make sure the principles of HACCP are in place. The auditor is also tasked to verify that the plan has documentation to back the effectiveness. This is a much more proactive system than the traditional “floors, walls and ceiling audit”. The focus is on preventing hazards from affecting the product rather than pointing out what is not compliant with current regulations.
The impact of HAACP on bottled water treatment equipment
How can HACCP plan affect the way the equipment is assessed during an audit? For one, if Cryptosporidium or E-coli have been identified as hazards, it is very possible that an RO unit, microfilter and/or ozonators may become a critical control point in the HACCP plan. The definition of a CCP is “a control that eliminates a hazard or reduces it to an acceptable level.” The processes provided by this equipment can certainly meet the definition of a CCP in most circumstances. If an RO unit is certified under NSF Standard 58 to be effective against Cryptosporidium and is utilized as a CCP, the RO becomes the center of the plan. It is regularly monitored for effectiveness. Gauges and flow meters will be monitored and the results documented on a daily basis. The total dissolved solids (TDS) will be measured as often as deemed necessary to assure proper functioning of the membranes. As part of the master maintenance plan, the RO unit will have regularly scheduled and documented maintenance. Pre-filter changes, membrane sanitation and other routine or special maintenance will be documented.
If during routine monitoring, it is found one day that the TDS has jumped to 100 mg/L instead of the typical 1 mg/L, the production is stopped and the corrective action plan kicks-in. Corrective action involves several dynamics. First, what happens to the product produced since the last acceptable reading? The plan has several options here, all based on evidence, known as validation. The plant may just destroy all the product produced during that time frame, or may go back in the lot to test and determine when the breach took place, destroying product produced after that time. The next step is a gap analysis. Why did it fail and how can the plant keep it from happening again? All these steps and processes will be documented.
The ozonator and other CCPs would be monitored similarly. For the ozonator routine maintenance and regular verification of the ozone residual in the product would be monitored to be sure that there is an effective residual of ozone present – again validated, or explained with scientific or historical evidence.
When it comes to safety, many certification elements tie together
The water related certification programs at NSF do overlap in many ways, especially in the bottled water program where treatment equipment, drinking water additives, plumbing and materials play an important role. With the advent of HACCP and process driven audits, the water treatments units are sometimes the “heart” and focus of a pro-active bottled water safety program.
About the author
Loren Merrick is the General Manager of the Bottled Water, Packaged Ice and Beverage Programs at NSF International. A former bottled water plant manager, and public health official, he has been with the NSF Bottled Water Program since 1992 and the General Manager since 2003. He has visited more than 300 bottled water plants around the world performing audits and auditor training for NSF. You can reach Loren at [email protected] or 800-NSF-MARK, ext 5762.