Stuff happens, and HACCP is an iterative process
When Bad Things Happen To Good People was a 1981 best selling book by Rabbi Harold Kushner that chronicled his life while dealing with the diagnosis of his three-year-old son’s degenerative disease that meant he most likely would only live until his teen years. The author and father explores the doubts and fears that accompany such terrible news and the years to come. Thankfully many of us have never experienced such an event.
Why does this relate to HACCP? Because those in the food industry have chosen careers that make us responsible for the safety of the nation’s food supply, and our efforts or lack thereof can harm the health of hundreds or thousands when bad things happen. And bad things do happen, as regular national headlines show. The 2011 Listeria monocytogenes outbreak from contaminated cantaloupes discussed in an earlier piece killed several and sickened many more. And those responsible were given a suspended jail sentence and fined severely. Examining such occurrences whether they happen to us or related businesses, and determining not only what happened but how to prevent it from happening it again is paramount. This is what Principle 5: Establish Corrective Actions is all about.
When bad things happen in the food industry they can become national headlines. In 2012 a US Salmonella outbreak was linked to a peanut butter supplier to Trader Joe’s, Whole Foods, and numerous outlets. A similar outbreak in 2008-2009 killed nine and sickened hundreds; the CEO of that corporation is currently going to trial for conspiracy mail and wire fraud and the introduction of adulterated and misbranded food into interstate commerce. Others in the company are charged with obstruction of justice (Link to Source).
Those versed in ISO 9000 quality processes are familiar with two major types of actions, corrective being one, preventative being the other. A US FDA presentation provides the following definitions for these terms along with some explanatory notes (Link to Source).
Corrective Action: action to eliminate the cause of a detected nonconformity or other undesirable situation.
Preventative Action: action to eliminate the cause of a potential nonconformity or other undesirable situation
The FDA give further guidance as to the steps that will be needed for a Corrective Action.
The FDA is also very clear on where to go from these three corrective actions. “As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product (Link to Source)." I would add that the documentation should contain a description of the non-conformity plus analysis and determination of the root cause.
As was noted in previous pieces about HACCP implementation, what can be easy to define may be more difficult to describe fully, and why taking the broadest view may be the safest. One challenge for the HACCP Team in Establishing Corrective Actions will be the potential push to bypass the process and to bow to business pressures to keep going even when things go badly. After all, businesses don’t make the money needed to pay us or our colleagues when they don’t ship or sell products. Thankfully managers know the risks associated with food safety and hopefully err on the side of extreme caution when something is found amiss during a production run.
Two examples of Corrective Action plans can help provide some ideas as to how to approach this step. The first is a more extensive plan that defines the Raw Material or Process Step, Hazard, CCP Monitoring, and Corrective Action (Link to Source). Each Item in the left column is addressed and most importantly the procedure and responsible person are identified. It is best if the responsibility is a specific person and not a department, QA or QC or Production for example since this would leave the process open to the perennial chasing of one’s tail with, “I thought X or Y was doing that.”
The second speaks directly and only to the Corrective Action Form itself (Link to Source). This is useful when an incident occurs and corrective action is underway. Note the date of the incident and each step as well as the person responsible for verification are noted along with a description of the problem and corrective action taken.
Both of these forms are for in-house nonconformities. When product is shipped and then identified additional steps are needed and may include customer notification, warnings, or even a recall.
A web search will reveal many other resources on the web to help get started. As in the previous steps and as in ISO processes, procedures are to be developed that match current practices and insure the desired results, and because of that the team will need need to customize or modify its processes to match their operation’s capabilities without compromising HACCP ideals.
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