As manufacturers wrestle with Food Safety and Modernization Act compliance, there is no denying one simple truth:![\"projects\"](\"https:\/\/b-spoke.net\/wp-content\/uploads\/2016\/08\/projects.png?w=300\")
once the regulatory genie is out of the bottle, there\u2019s no turning back. Regulations rarely become less stringent, and inspections and audits rarely become simpler over time.<\/p>\n
Waiting until the Food and Drug Administration has fully codified the rules and begun enforcement is not the time to start implementing your compliance plan. At Kepner-Tregoe, we have seen too many organizations caught in a cycle of catch-up, leading to skyrocketing costs of compliance and panicked goose chases for data, while managers (Quality and otherwise) get bound by bureaucratic red tape.<\/p>\n
This was underscored at September\u2019s (2013) Food Quality Symposium in Phoenix, Arizona, by Dr. David Acheson, director of the Food and Import Safety Practice at Leavitt Partners, and the former chief medical officer for both the FDA and the U.S. Department of Agriculture\u2019s Food Safety and Inspection Service, and Sarah Geisert, Senior Director, Global Product Safety and Regulatory Affairs at General Mills.<\/p>\n
Planning and organizing for the new regulatory environment \u2013 and properly implementing those plans \u2013 can be the difference between success and suicide. Not only in terms of regulatory, but in our current world where social media is a public relations behemoth, there cannot be a single misstep in terms of regulatory or market perception when it comes to food safety. As Dr. Acheson cautions, when things go badly with the FDA and USDA; that is a headache. When things go badly with our customers; that is the end.<\/p>\n
So how do manufacturers stay ahead of the curve when compliance rears its head? We hear consistently how critical documentation is; but documentation is not the means to the end. Sarah Geisert stated it most clearly, \u201cYou have to have process.\u201d She, and we at Kepner-Tregoe, define this as \u201cthe walk;\u201d involving the right people, at the right time, in the right way, to ensure each person is doing the right thing. Clear, consistent thinking drives success \u2013 across different levels of the organization, across different functional areas, even across different locations.<\/p>\n
Facilities that have thought clearly about how to operate under the new rules and have executed rational processes in preparation, will be in better stead. With a solid corrective action mindset in place, audits and exceptions can be treated as individual, manageable episodes \u2013 not devastating and distracting sagas, wrought by an unreasonable watchdog.<\/p>\n
![\"listeria\"](\"https:\/\/b-spoke.net\/wp-content\/uploads\/2016\/09\/listeria.jpg\")
Shawn Stevens, National Food Safety attorney submits this theory: Access to records is needed for the FDA to determine if your product is a risk. Visible, transferable process can help you operate and perform. Further, the Agency may conclude from your records whether or not you are at risk.<\/p>\n
As so many people asked at the symposium, \u201cWhat tools do we need to effectively plan, organize, and implement for success?\u201d \u201cHow do we get ahead \u2013 particularly in a world where resources are limited and time is precious?\u201d \u201cHow do we ensure that our thinking is robust enough and consistently applied?\u201d<\/em><\/p>\n We have found there are four phases where thinking clearly will provide manufacturers a key competitive advantage:<\/p>\n Effective preventive action plans define a framework for avoiding issues and provide a \u201csafety net\u201d to get back on track before incidents become problems. When we asked one Director of Quality to describe his role as he sees it, he replied without blinking, \u201cKeep the CEO out of jail.\u201d While that may seem tongue-in-cheek on one level, it also underscores the zero-tolerance environment of food safety, which requires diligence and focus across the organization.<\/p>\n Identifying \u2014asking \u201cWhat could go wrong?\u201d\u2014results in an understanding of potential risks and their likely Protecting quality is not t<\/em>he Quality Department\u2019s job. It\u2019s everyone\u2019s job. Knowing how to Manage Involvement<\/em> \u2013 whether to be autocratic or democratic, when to manage by consensus or fiat – is crucial. Well-orchestrated involvement of people leads to the high level of commitment that moves an organization toward common goals.<\/p>\n Even the most brilliant plan offers no value unless it is implemented. Good Project Management<\/em> techniques at this stage help clarify and build agreement around the action plan\u2019s scope and purpose. Effective teams know ahead of time what the plans will accomplish \u2013 and what they won\u2019t<\/em>. Project planning identifies resources and optimizes schedules.<\/p>\n Following our previous analysis of Potential Problems<\/em>, Quality managers can bullet-proof the plan\u2019s implementation. Here, you can analyze \u201cWhat can go wrong?\u201d around resource (human, equipment, material) shortages, scheduling conflicts, personnel decisions, outside interference, and more; again, clear triggers will alert you if the project is in danger of missing its mark and will allow for appropriate corrective actions.<\/p>\n Project Management<\/em> skills come into play to monitor progress against the plan and modify activities, as necessary, to ensure timely execution.<\/p>\n Operating under this new environment will require changes in peoples\u2019 behavior \u2013 throughout all levels of the organization. Successful organizations understand that defining the Performance System<\/em> correctly \u2013 setting clear expectations and removing roadblocks \u2013 is as critical to success as the employees\u2019 skills and capabilities.<\/p>\n Conditions change, and successful plans change with them. By using a systematic process to clarify concerns, agree on their relative priority, and ensure they are effectively resolved, the team can make sense of the shifting landscape.<\/p>\n A well-designed machine may be \u201cset it and forget it\u201d but people are not. Managing the Performance System<\/em> at this point means providing pinpointed feedback and \u201cbalancing\u201d the consequences, that is, making it easy to do the right thing becomes an ongoing function of leadership. The days of Command and Control \u2013 \u201cDo it because I said so\u201d \u2013 are long gone.<\/p>\n The Number One concern we hear from food manufacturers \u2013 from the C-Suite to the plant floor \u2013 is, \u201cWe just don\u2019t know how to troubleshoot effectively.\u201d In the food safety environment, this is no small capability gap. As Stevens said and we all know, \u201cGet to root cause to prevent outbreaks. Government and media, consumers and While every company\u2019s details and challenges are unique, in the food industry, the risks of getting it wrong are too high. Having a process that allows manufacturers to audit themselves is one of the critical factors of competitive advantage. Cross-functional preparedness, getting the right people involved in the right way, at the right time, doing the right things; these are common themes where using rational, clear-thinking processes can significantly reduce the stress and uncertainty currently felt.<\/p>\n Food safety professionals are the gatekeepers of brand equity. No silver bullets can eliminate all of the risks of running an operation. Thinking clearly through the issues and consistently applying common processes in a common language, throughout your organization, minimizes the chances that the Quality Department becomes both scapegoat and firefighter once these laws go into effect. As Theodora Monille-Hinds, Senior Director of Global Food Safety and Sanitation at Kellogg\u2019s says, \u201cFSMA should influence the way I think about safety, so that I can be ready for whoever shows up at my door.\u201d<\/p>\n <\/p>\n Save<\/span><\/p>\n Save<\/span><\/p>\n Save<\/span><\/p>\n Save<\/span><\/p>\n Save<\/span><\/p>\n","protected":false},"excerpt":{"rendered":" Preparing an organization for change – whether internally driven or mandated by external influences – combines the tools of project management, problem-solving, and good decision-making.<\/p>\n1.\u00a0\u00a0\u00a0Building a Plan<\/h5>\n
![\"ppa-blended-background\"](\"https:\/\/b-spoke.net\/wp-content\/uploads\/2015\/04\/ppa-blended-background2.png?w=218\")
causes. Once prioritized, assigning preventive actions against these causes reduces their likelihood. A thorough analysis also delineates appropriate contingent actions to minimize the impact, should something go wrong. Setting proper triggers for action ensures this backup plan isn\u2019t gathering dust on your shelf while troubleshooters swarm in a panic.<\/p>\n2.\u00a0\u00a0 Implementing the Plan<\/h5>\n
3.\u00a0\u00a0 Managing the Plan<\/h5>\n
4.\u00a0\u00a0 Deviating from the Plan<\/h5>\n
![\"fruit-bowl\"](\"https:\/\/b-spoke.net\/wp-content\/uploads\/2016\/09\/fruit-bowl.jpg?w=300\")
congress are all watching, so problem prevention is critical.\u201d An effective root cause analysis process provides visibility into the \u201chow to\u201d of determining root cause\u2014that thread of logic that auditors expect to find when examining investigation reports. By transferring these skills throughout your organization, your staff, using a shared language and common process, can collectively resolve critical business issues that continue to pay dividends over time.<\/p>\nConclusion<\/h4>\n