Friday, June 22, 2018

What Does a Food Safety Plan Really Consist Of?

By: John Spillson

In 2011 President Obama signed the Food Safety Modernization Act (FSMA) into law, bringing about the most sweeping changes the food safety industry has seen in 70 years. This introduced the Food Safety Plan (FSP), which is the primary document that guides your Preventive Controls Food Safety System. While the ‘why’ of the FSMA has been publicized quite extensively, not as much has been explained about the ‘who,’ ‘what,’ ‘how’ and ‘when.’

To answer these questions, we must first start with ‘what’ it is in order to understand ‘who’ should be involved and ‘how’ to comply, as well as ‘why’ you’d want to. Previous food safety standards were mostly reactionary, while the new movement puts its focus on prevention through risk-based analysis. The focus of the new FSP lies in the prevention of hazards throughout the process. The FDA is granted more authority to offer guidance and assess fines and fees, as well as order recalls (which had previously been left to individual companies). Food processors also are now tasked with incurring more inspections, increasing record keeping and monitoring supply chains.

The crux of the FSP can be summed up in two words: preventive controls. Preventive controls are specific to a facility and product, taking into consideration the severity of a hazard as well as its likeliness of occurring. The process of preventive controls begins with understanding the food safety pyramid (not to be confused with the food group pyramid). As seen in the figure below, the foundation of every FSP should be well-written and effective Prerequisite Programs (PRPs), current Good Manufacturing Practices (cGMPs) and Sanitation Standard Operating Procedures (SSOPs). Quite often preventive controls will exist in these foundational programs.
HACCP and HARPC plans, the next level on the pyramid, rely on solid PRPs, cGMPs and SSOPs in order to be effective. Only after these robust standards are in place can you consider a Global Food Safety Initiative-recognized scheme such as SQF, BRC or FSSC 22000. Having a solid understanding of the four categories where hazards may lie – physical, chemical, biological and radiological – helps develop the game plan for preventing these hazards from occurring.

The three big takeaways here are to identify, prevent and document. Identify the potential hazards or risks by considering their severity as well as likeliness to occur. Prevent and/or control the identified hazards through a proven or documented successful means. And finally, document, document, document. There must be a record of how an identified risk is controlled. If it’s not written down it didn’t happen. Recall plans also are an integral part of an FSP. Names, numbers and contact information must be readily available in order to contact the Reportable Food Registry, regulatory officials, impacted customers and even the public. It is best for food processors to think of themselves as food safety companies that happen to produce food.

Now that we know what it is and how to comply, we should explore who must be involved, and when they need to be compliant. New to the food safety acronym world are QI and PCQI.  QI, or Qualified Individual, is the name given to the person in the facility who performs a task. It doesn’t matter what the task is, as long as the person doing it has been adequately trained in performing that particular part of the process.

Second, and the true manager of the FSP, is the Preventive Controls Qualified Individual, or PCQI. The PCQI holds the most important role in the FSP: to develop, write and maintain the FSP. They must verify and validate the preventive controls as well as establish corrections or corrective actions when there has been a deviation from the FSP. This individual also needs to reevaluate the FSP every three years (or after any recall or significant change in a process). In order to become the company’s PCQI, an individual must either have adequate knowledge or job experience to develop and apply a food safety system, or complete a PCQI certification course.

In terms of who this applies to and when you must comply: Unless your company is so small and have been given an exemption, you’ll need to have an FSP, complete with a recall plan in order to sell your packaged food in a retail setting. Food processors with sales above $1M and more than 500 employees were required to comply by September of 2016, while small processors with fewer than 500 employees had to comply by September of 2017. Very small processors, those with sales below $1M, must comply by September of 2018.

FSMA brought forth many challenges and new ways of thinking for food processors, bringing benefits as well for safely producing food products. The old days of being reactionary now have been replaced with progressive, forward-thinking methodologies that aim to eliminate or control known hazards.

At The Center, we often work on-site with food processors to improve their efficiencies and make lasting changes. Additionally, we offer a one-day Fundamentals of Food Processing course that touches on FSMA/PCQI requirements and responsibilities, as well as the only recommended course to certify PCQIs. To learn more about these courses, or to register for an upcoming class, contact or call 888.414.6682.

John Spillson
Food Business Development Manager

John works to develop and expand the food program at The Center. His experience operating his own business has given him knowledge in production, sales, food safety, marketing, warehousing and logistics. John comes from a long line of entrepreneurs, following both parents and grandparents in operating their own family food businesses. Prior to joining The Center, John owned and operated his own food processing company for more than 20 years. He loves helping food processors almost as much as he loves food itself.

Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

Friday, June 15, 2018

Stop Risk Before Risk Stops You: 5 Steps to Effective Risk Management

By: Roger Tomlinson

All successful project managers have one crucial ability in common, which ensures their projects never get derailed or end in disaster: effective risk management. This essential aspect of managing projects involves identifying, assessing and responding to potential project risks. Mastering risk management can improve your project management skills overall by guaranteeing your project is delivered on time and on budget, every time.

Looking to take your project management skills to the next level? Start with understanding project risks. Project risks are any elements that might affect your project. Although these risks could potentially have positive implications, they are generally associated with being negative. These risks can lead to any number of problems for your project, from your team not having the manpower or skillset required to complete a task, to critical raw materials not being available in the timeframe required.

Unchecked risks also can result in larger issues with following your schedule, meeting quality requirements or staying on budget. If not managed correctly, project risk can make it harder, or even impossible, to successfully deliver your project.

So how can you safeguard your project from disaster and keep it on track for success? The answer lies in creating a risk management plan. Read on for five steps to establishing a flawless risk management plan to set up your project for greatness.

Step 1: Identify the Risk
The importance of identifying and tracking risks cannot be understated. Building awareness of as many risks as possible will heighten your chances of successfully avoiding or managing risks. Creating a risk register, or list of potential project risks, can help you get a step ahead of all potential risks before they become problems. Your risk register forms the basis of your risk management plan, establishing an ongoing list of any risks that might impact your project. Hint: Lessons learned from past projects can be used to inform current risk registers. This list also should be maintained throughout the project lifecycle, as risks can appear and disappear as your project progresses.

Step 2: Assess the Risk  
Once risks have been identified, you must determine the associated cost of risks compared to the cost of mitigation efforts. This requires estimating how much a potential risk could cost the organization based on its probability, detectability and severity. Measuring risks in this way can ensure that everyone involved has a clear idea of what might happen, and what might be lost, if any of these risks arise.

Step 3: Plan Responses
What if these risks do arise? You should have an appropriate response plan in place for each potential risk.

Generally, there are four response categories that all risks fall into, which determine what you can do to address and manage a project risk. They are:
  • Avoid: Change your plans to dodge the risk entirely.
  • Transfer: Outsource the risk to a third party to manage the issue.
  • Mitigate/Reduce: Reduce the impact or likelihood of the risk.
  • Accept: Take the chance of a risk occurring.
Although unlikely, it is possible that some of your risks might have positive outcomes. For example, you might be at risk of selling so much of your product that a capacity issue arises. While this does have positive implications, it is best to plan for this type of situation in advance to avoid any related issues.

In the event that such a positive risk occurs, potential responses include:
  • Exploit: Ensure that the risk occurs to realize its positive benefits.
  • Share: Work together with a third party to achieve an opportunity associated with a risk.
  • Enhance: Increase the chance of a risk occurring to achieve its benefits.
  • Accept: Take the chance of a risk occurring.
Based on these categories, you can decide which response is best suited for the risk at hand. For example, you might decide that the risk of a bus driving into your office is something you’ll simply accept, as it isn’t very likely to happen. However, the risk that food poisoning takes out half of your workforce is something you will have to actively mitigate by ensuring all catering staff is properly trained.

Once the response is established, risk owners can be appointed to carry out each risk management action plan. Completion of this step demonstrates that you have thought through all potential risks and put plans in place to reduce uncertainty on the project.

Step 4: Implement Mitigation
Now that risk owners have been appointed, they can be held responsible for completing the necessary tasks for managing any open risks.

Reporting on the mitigated risks will help your management team see that you are serious about future-proofing your project against problems, while also providing mitigation plans to look back on if similar risks arise in the future.

Step 5:  Risk Monitoring
Once the risk management plan is finished and put into place, with risk owners, plans and risk registers actively at work, you will have to continually monitor all results throughout the duration of your project.  These reports also can be used as communication tools to keep all involved personnel aware of risk management outcomes.

Risk management can help any project run smoother, while further enforcing your creative and strategic capabilities as a project manager. By determining risks and actively managing problems before they happen, you can set yourself apart as a successful project manager and ensure you are prepared for any problem that might be thrown at you.

Roger Tomlinson
Lean Program Manager

Roger has been a Program Manager in The Center’s Lean Business Solutions program for 18 years. He has trained and mentored hundreds of Michigan manufacturers in the entire portfolio of Lean strategies and methods (e.g., Kaizen events, Standardized Work, 5S/Workplace Organization, Value Stream Mapping, Total Productive Maintenance, Culture Change, Team Building, operations management and process re-engineering). In addition to his training and consulting work, Roger has over 20 years of experience in manufacturing management.

Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

Friday, June 8, 2018

There's Nothing Artificial About This Intelligence: How to Get the Facts You Need to Know

By: Shelly Stobierski

While “artificial intelligence” is a trendy buzz term in manufacturing today, there’s another type of intelligence that offers you a valuable strategic advantage: competitive intelligence. This method of market research is based on using tactics to continuously monitor the market and gather information to help your company keep up with the latest innovations, trends, competitor news, potential customers and a wide range of information that is meaningful to your operation.

Regardless of company size, type or budget, your business will benefit from an increased focus on what's happening in your industry and its potential impact on your growth and success. This is now more true and important than ever as newly introduced technologies and practices continue to change the manufacturing landscape at a rapid pace.

When faced with the daunting task of monitoring and implementing the latest innovations in the industry, many manufacturers choose to postpone their own implementations and instead watch competitors adopt technologies first. However, those who choose to take this “safer” route risk falling permanently behind as the market continues to advance without them. Fortunately for manufacturers, there are a few basic options that can streamline the process of continuous monitoring and make such improvements possible for companies of any size.

MYTH: Competitive Intelligence is Too Expensive for Me
With the right tools, competitive intelligence can be catered to your needs, your schedule and your budget. For example, setting up a “listening post,” or an email alert that gathers online content related to certain keywords, is one easy and free way to monitor the market. These keywords can be aimed toward something as broad as market news, or as specific as finding project proposals to connect with potential clients. You have the flexibility to decide how to use these alerts to boost your performance.

MYTH: Competitive Intelligence is Too Time-Consuming for Me
An added dimension of flexibility comes with deciding how often to receive these emails. When setting up your alerts, you are given the option to decide how often or infrequently the emails should be sent out so as not to overwhelm your inbox. This allows you to manage how much time your competitive intelligence research will take up each week, tailoring it to your own schedule.

It should be noted that your monitoring should not end after just one day of research. While it can be beneficial to gain a single snapshot of the industry, your company will get the most valuable information and insight from engaging in continuous monitoring of the market. After all, new technologies are introduced to the market each day. Although your company does not have to change as quickly as the industry itself, it would be helpful to start taking steps toward better and more competitive business practices with methods such as these – before the industry leaves you behind.

Monitoring the market using competitive intelligence should be a tactic that is as common as monitoring your machinery, inventory levels and budget. As noted above, it does not have to be overwhelmingly time-consuming or expensive. Simple tools can help your company gain a competitive advantage, identify opportunities and threats, and generate new business opportunities. All it takes is the desire to improve.

To learn more about how to empower your business with competitive intelligence, contact The Center at or call 888.414.6682.

Shelly Stobierski
Director of Research Services

Shelly Stobierski is the Director of Research Services for the Michigan Manufacturing Technology Center. She has more than 15 years of market research experience, the first 10 years with a primary focus on automotive-related manufacturing businesses. Shelly has extensive skills in survey research (phone, internet, focus groups) and in the use of proprietary industry databases. Prior to joining The Center, Shelly spent five years as a research analyst for a turnaround firm conducting secondary research with databases such as LexisNexis, Capital IQ, and IHS Automotive forecasts. That was preceded by seven years working in various levels of project management at leading primary research firms.

Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

Friday, June 1, 2018

How Football Can Help with Auditing a Process-Based QMS

By: Andy Nichols

An important requirement of ISO 9001 (and its “cousins,” AS9100 and IATF 16949) deals with internal quality management audits. One purpose of this internal audit program is to look at the processes within the quality management system. Common questions that internal auditors raise during this practice include, “How do I audit a process?” “Which processes should I start with?” and “How will I know if the process is effective?”

Starting at a very basic level, a process can be defined as “activities that transform inputs into outputs.” One might add to this definition that the activities occur “under controlled conditions,” since we usually prefer to be able to predict a (good) result or output! From this definition, we know a number of things already about any process, including that they have:
  • Input(s)
  • Output(s)
  • Activities
  • Controls
This is helpful to start with, but heading off to do an internal audit with only four topics on a checklist is unlikely to help us reveal if a process is working as intended. Auditors must build from this list by developing a better understanding of what is needed for a process to deliver a satisfactory outcome - for both the organization and its customers.

Most business processes have some form of goal or objective assigned to them, which can be focused externally on customers’ needs or internally to the organization. These goals make it so that performance and success can be more effectively measured. If the process is working effectively, it’s by this performance criteria that an auditor can tell what is being achieved.

In addition, it’s desirable to produce a consistent result; therefore, the process must be under control. Most of us know the wailing sound (output) a loudspeaker makes when a microphone (input) is placed too close to it – that’s called feedback! You can certainly measure the sound level using this practice, but the process is out of control! Our business processes need controls to ensure that things don’t get out of hand.

Process controls may be accomplished in many ways, including:
  • People – competent, aware and trained
  • Equipment – capable and maintained (calibrated, if necessary)
  • Methods – procedures and work instructions (as necessary, under document control)
  • Materials – approved, available, identified, etc.
In listing these controls, our gathering of audit topics has grown quickly – but it’s not finished yet. We must also consider some other necessary controls, including documentation controls, non-conformance, records generated from the process, corrective/preventive actions and improvements.

The challenge with preparing for any audit is figuring out the sequence in which to place these so that we can gather useful information about the process, rather than just compliance-based facts. After all, arriving at a machining cell and asking for records of maintenance before you have established what product is being made, how many, and so on, will not reveal much useful information.

To make this process of planning an approach easier for auditors, a number of visual metaphors have been developed. One unique approach that has proven successful in helping auditors to organize these topics into an appropriate sequence – or “game plan” – is called the ‘Football©’.

Using this football-shaped tool to ‘visualize’ the path an internal auditor should take when auditing has a number of advantages:
  1. More comprehensive planning so that all relevant controls are considered, and in their correct sequence. The above example can be easily applied to a manufacturing process. It also can be tailored to fit the structure of audit checklists or questions. This allows information to be gathered and used later to verify performance. This football diagram can assist an audit manager with ensuring the assigned auditor(s) do the relevant research of those requirements and controls so that they develop a better understanding of them before the audit interviews begin. The auditor then has a ‘bigger picture’ to audit and is therefore more likely to identify systematic issues.
  2. Better equipped to evaluate the results of the process when compared to what was planned to happen (not just the transformation of inputs). Auditors are then able to identify places within (or supporting) the process that could cause the plan not to be achieved (scrap, rework, downtime, etc.). 
  3. Better time management through adherence to audit scope, etc. By populating the various ‘bubbles’ (in the example above) with the details of the organization’s management system and/or customer requirements, etc., the auditor is able to get a clearer understanding of the expected outcomes. They are then more capable of identifying where supporting processes are effective, without having to follow multiple “trails.” It is often easy for an internal auditor to be ‘drawn off track’ when evaluating these other criteria and controls (depicted by the football’s laces) that can affect a process – calibration and training, for example. The football can assist auditors in defining the ‘boundaries’ at which point they must decide to return to the normal process flow.
Conducting process-based internal quality management system audits can be an overwhelming task for many auditors. As a result, it is common to have compliance only-based reports (“we did/didn’t follow procedures”) instead of confirming effectiveness of the process. The use of a planning tool like the football to map out an auditing strategy leads to far more effective – and efficient – audits and helps the auditor focus on validating the results of the process to the goal.

Learn more about how to use the football diagram when planning for any process-based QMS audit at The Center's upcoming free Explore event on June 26 from 8:30am-10:30am.

Andy Nichols
Quality Program Manager

Andy has 40 years of expertise in a wide variety of roles and industries, with a focus on quality management systems in manufacturing organizations. In addition to his ISO 9000 Management Systems experience, he has worked extensively with ISO/TS16949, ISO/IEC 17024 and ISO/IEC 17025. His broad practical knowledge of ‘Quality Tools’ includes: SPC, FMEA, Quality Circles, Problem Solving, Internal Auditing and Process Mapping. He also has been an IRCA and RABQSA accredited Lead Auditor.

Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at