Quality

Why Is There a Shortage of Baby Formula?

May 27, 2022 By

By now, everyone’s heard about the shortage of baby formula in the United States. It stems from the fact that over 90% of U.S. infant formula is made by only 4 companies: Abbot, Mead Johnson, Nestle, and Perrigo. But, how did this happen? There are three, primary causative factors:

There has been a lot of consolidation across the food industry over the past few years, with big corporations buying-up other companies.
The governmental food safety regulations for infant formula are extremely strict. Only companies with access to money and resources can produce these types of products. In addition, the FDA placed strict restrictions on imported formula, despite the fact that many countries have food safety standards that meet or exceed domestic standards. Because of this, the U.S. now manufactures 98% of our formula supply.
About 50% of infant formula sales go through the federal Women, Infants, and Children (WIC) program, which equates to about 1.2 million infants. WIC contracts utilize a sole-supplier methodology, so two companies (Abbot and Mead Johnson) account for about 90% of WIC contracts in the US.

Beyond the reasons listed above, baby formula manufacturers are currently facing the same supply chain and workforce issues faced by manufacturers across the world. Interruptions in the baby formula supply chain, coupled with the fact that the FDA shut down a major producer earlier this year due to an extensive recall, created a perfect storm for the shortage.

Read more about reasons for the baby formula shortage and what actions have been taken to help alleviate the problem, in this recent article that I contributed to in the Washington Post: US safety, savings rules set stage for baby formula shortage.

What can manufacturers learn from this and what actions can be taken by companies to guard against future shortages of other products?

Food manufacturers can take steps to put food safety and quality first, to avoid consequences such as recalls or shutdowns. Learn more about the food safety training and implementation services provided by GaMEP at our food and beverage industry page.
All manufacturing companies can review their supply chain and use strategies to diversify and mitigate risk. Contact us for more information on how GaMEP can help.

By: Wendy White, GaMEP Food Industry Manager

Are Virtual Food Safety Audits as Effective as Onsite Audits?

April 21, 2022 By

The food manufacturing industry utilizes governmental and third-party food safety audits to ensure the quality of the products being produced and the safety of consumers. However, over the past few years, as manufacturing companies have limited the number of guests in their facilities, many have wrestled with the question of how to conduct a food safety audit with a remote auditor.

GaMEP’s food-industry project manager and food safety expert, Wendy White, recently wrote an article for Food Safety Magazine discussing:

The pros and cons of virtual audits vs. onsite audits
The unique challenges of remote auditing
How wearable technology and other virtual audit tools have greatly improved in the past few years
How remote auditing helps meet the growing need for third-party food safety audits with a shortage of qualified auditors available
Whether virtual audits are an acceptable alternative for onsite audits for the long-term

Read the full article here: Advanced Technology for Improving Virtual Audits and Inspections

Find out more about how Wendy helps companies improve their food safety and quality programs: GaMEP Food and Beverage Industry Services Page

A Professional’s Journey through Manufacturing and Safety Training

January 5, 2022 By

Creating a Culture of Success – Committing to Quality and Safety Education

Faith Allem , quality and safety compliance leader at Hitachi T&D Solutions, Inc. in Suwanee, Georgia, has been taking training classes at Georgia Tech for 20 years. She started her journey in quality and ISO auditing, working at Georgia Power in quality management. She then went to Hitachi where she expanded into safety and health management as her 14-year career evolved.

“Georgia Tech has been my go-to in professional education. The courses have helped me gain the knowledge to advance the quality and safety programs for the companies I have worked for and proven that when safety is invested in and not treated as an afterthought, it directly and positively affects business performance.”

Faith has been successful driving improvement through her commitment to quality and safety. She credits her training and enthusiastic instructors, like Craig Cochran, project manager for the Georgia Manufacturing Extension Partnership (GAMEP) (who she has known for 20 years), with keeping the classes engaging and relevant.

According to Faith, “You can learn regulations and requirements anywhere, but at Georgia Tech the classes are really interactive. Not only are you learning the requirements, but you are also working on how to apply them to real life business situations. This class structure builds confidence and relationships because you can ask the expert instructors for advice right in the moment.”

In this interview, Faith reflects on her training experience and how it has helped shape her career.

After taking 10 quality and ISO focused courses at Georgia Tech, what did you expect to gain by enrolling in the safety & health certificate program and did it meet your expectations?

I knew that Georgia Tech offered a Manufacturing Leadership Certificate program, but I wanted to build on my quality training, and taking safety classes was a natural fit. Earning my Safety and Health Management Certificate allowed me to expand my compliance knowledge, apply what I learned to improve current processes, and show upper management that there is value in building more robust safety programs and investing in training like this.

Investing in Career Growth with Georgia Tech Training

What did you find most valuable about your quality and safety training journey?

The instructors have an enthusiasm that keeps you engaged and excited about the subject matter that’s being taught. They are supportive and continue to be my go-to resource even outside of the classroom. I was very impressed that during COVID the Georgia Tech team did not stop. They were creative and inventive when pivoting to remote offerings and utilizing web based learning platforms to keep the classes interactive and interesting. This allowed me to keep going and finish my certificate on time.

How have you applied what you have learned in your current position?

The first thing I did was institute proactive planning with my teams. I used the tools from my different classes to create safety kits, incident/accident forms, and a dedicated company website to reinforce good safety behavior among employees. To get everyone on board and invested in the outcome of our new program, I created incentive programs with different types of rewards to reinforce practicing good safety behavior. As a result, we have improved the quality and safety of our current systems and it has changed the company culture. Over the past six years, we have seen a dramatic reduction in customer complaints, safety related accidents, and loss cost. Just one year under my leadership, our safety risk assessment investigation findings are down over 80 percent. I think this shows that a continued commitment to self-development leads to positive outcomes personally and professionally. This program has not only contributed to my own self-growth, but to my team and company as well. It all comes full circle.

In your opinion, what does it take to be successful in the manufacturing and safety field?

Management support is critical. The more I learn, the more knowledge I can bring back, share with the team, and help them to develop and improve on our current systems. This shows value to our upper management and creates an inclusive environment where continuous improvement and safety is everyone’s responsibility. We really care about every person’s safety. It’s not just checking off the requirement box and moving on. It’s about taking that requirement and making it work for your company.

To learn more about the GaMEP Manufacturing Leadership Certificate or other training programs, please contact your GaMEP Region Manager for more information. If you have any safety needs or questions, please reach out to one of the SHES experts for a consultation.

The Do’s And Don’ts of Preparing A New Facility For The First Audit

May 4, 2021 By

Starting a new facility is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment. This scenario is a perfect example of “Too much to do and not enough time to do it!”. There’s always significant pressure to get up and running to start the return on the company’s enormous investment. To further complicate the situation, most customers require one or more audits of the site’s Food Safety Quality (FSQ) System before the first sellable product can be produced on the line. These qualifying assessments range from a casual, on-site visit by the customer to a Global Food Safety Initiative (GFSI) audit.

Meeting the ever-increasing standards of something as daunting as a full-blown GFSI audit can be an intimidating prospect, and success can only be achieved through strategic planning. There is so much to be done to get the plant running before looming deadlines, which often leaves little time to prepare for initial audits. This is a race against the clock, but success is possible through alignment, engagement, planning, and prioritization.

Get Everyone on the Same Page

The biggest pitfall of any quality leader is trying to execute all the audit preparations themselves or only relying on members of the Quality Department. The key to avoiding this is to engage management and distribute audit preparation activities across different departments. Before this can happen, a strategy, or Audit Preparation Plan, must be developed and agreed upon by all applicable stakeholders. Upper management must be involved and aligned on the resources needed. This process starts with an internal assessment of the audit requirements to understand where the gaps are and determine the best solutions. Create a sensible timeline and have routine follow-up meetings to discuss progress and assign resources. Make adjustments to the plan where needed and ensure that there is proper accountability for those responsible.

Another mistake is ignoring employees outside of upper management. Understand who is going to be executing these programs and involve them from the start. Sometimes the creation of effective systems isn’t as big a challenge as creating sustainable ones. The best way to ensure that FSQ Systems will continue to operate smoothly comes from engaging the employees that carry out the day-to-day operations. Gain buy-in from empowering them to take part in how quality tasks are monitored. Simply asking advice about how worksheets should look or where to store tools can go a long way. They are the ones that are going to take these newly-created programs and make them into a reality.

Dealing with Delays

If there is control over the audit date, ensure there is sufficient time for all the preparations. Despite best efforts, sometimes things don’t go according to plan. Meet with the management team and see if there are ways to makeup the time or shuffle resources. It might be unavoidable that an unforeseen delay occurs and a deadline can’t be met.

If there hasn’t been enough time for the proper preparations, consider approaching the customer and asking for more time. It doesn’t set a good precedent to continually push back an audit date, but it might be necessary. This setback is usually a better choice than failing an audit or compromising the safety of your product.

This decision is just one more risk assessment to be done. Consider all the variables and decide if a delay causes more damage than an unsatisfactory audit score. Be transparent about progress to the management team, corporate officers, and applicable customers. A little warning will make a possible delay more palatable.

Borrow with Pride

It’s imperative to leverage every asset. Often, new plants have established sister plants with mature FSQ Systems already in place. Borrowing templates, verbiage, and existing systems are all extremely smart ways to save time when developing these programs for a new site. Remember that borrowed items must be carefully reviewed and tailored for that facility. The type of product, workforce, equipment, customer and regulatory requirements must all be taken into consideration. The best advice for starting a new facility is to never start from scratch unless that’s the only option.

There are a tremendous amount of resources out there. University extension specialists are a wonderful support option for understanding and complying with applicable governmental regulations. Trade and professional organizations are a well of knowledge and experience that can be tapped. There are also experienced consultants that can aid in almost any step in this process. Their services include creating HACCP (Hazard analysis and critical control points) and food safety plans, aiding with practice audits, training staff, and setting up specific programs. Interns or temporary staff can also contribute to creating new programs.

Vendors like pest control companies, chemical suppliers and outside laboratories can be a surprising source of aid. They are often a well of knowledge and have already prepared training, sometimes documentation that can be easily converted to meet the plant’s needs. They have a vested interest in the plant’s success and will often go to great lengths to offer support. It never hurts to ask.

Simplicity is the Key to Success

Quality leaders are often perfectionists, driven by the need to meet every requirement to the letter. One of the biggest pitfalls that a new plant can fall into is over-complicating their FSQ Systems. The harsh reality is that there isn’t always going to be enough time to do everything in the beginning. Some items on the list might have to be delayed due to time constraints or unavailable resources.

Producing safe food in a workplace that is safe for every employee is always the starting point. Everything else can be prioritized from there. Making a list of all the key tasks and required documentation and prioritizing it is the best way to ensure that the vital systems are in place. For example, having a statistical process control system in place isn’t going to be as vital to operations as a fully implemented Food Safety HACCP Plan. Determining the time and resources each task will take also needs to be considered in this prioritization planning. Ensure that input is gathered from other departments and members of management.

These first few months will set the tone for a site’s developing food safety culture. It’s important to be meticulous but not too rigid. The best FSQ Systems evolve over time but always start with a solid base that is created by prioritizing what is truly important. What has worked at one location might not work at another. If the deadlines are looming too close, don’t be afraid to recruit aid in the form of colleagues, universities, vendors or consultants. After the initial audit is complete, ensure that any corrective actions are established for any nonconformances identified. Share the results, not only with those that aided in audit preparations but all associates at the site. Celebrate the wins and learn from the losses together to build a stronger team for the future.

By: Wendy White, Industry Manager, Food Safety and Quality, Georgia Manufacturing Extension Partnership

How to Avoid the 10 Biggest Quality Mistakes

March 29, 2021 By

Learning from other people’s mistakes is one of the most effective ways to improve. There are plenty of mistakes out there to learn from, but the trick is to recognize them and understand what to do instead. Let’s examine the 10 most common quality mistakes and see how they can be corrected.

1. Limiting quality objectives to traditional quality topics

Quality is reflected in everything your organization does, and a quality objective can be anything measurable that relates to your organization’s success. A quality objective might relate to finances, customer feedback, safety, efficiency, speed or innovation. All these attributes relate to quality in one way or another. When selecting quality objectives, it’s important that your organization examines what matters most to its success. Whether the resulting measure is tied to traditional quality control or quality assurance is irrelevant.

2. Holding infrequent management reviews

Management review is the process by which top management analyzes data, makes decisions and takes action. Ideally, it’s a preventive process because data should indicate developing threats before they blossom into full-blown problems. Top managers should be able to analyze data proactively to prevent problems. Holding management reviews frequently allows you to review real-time data so that actions can be preventive. If these meetings are held only once or twice a year, however, you will not get the information that is necessary to make important decisions for your company’s success.

3. Sending out long, complex customer surveys

Instead of a survey, why not simply ask your customers what they like and dislike? Don’t limit their responses to survey topics. Let your customers dictate the content of their feedback in response to open-ended questions. Few questions are more powerful than the following: What do you like? What don’t you like? What would you like to see different in the future? Open-ended feedback is also much easier to understand and take action on. A customer-satisfaction index of 3.8 is hard to interpret. On the other hand, seven out of 10 customers telling you that your Web site is confusing and pinpointing what makes it confusing provides a clearer path to improvement.

4. Assuming everyone knows what “nonconforming” looks like

When I visit organizations, one of my favorite questions is, “Where do you put the nonconforming products?” Control of nonconforming products is one of the most basic kinds of controls, and it speaks volumes about the rest of the controls embraced by the organization. Smart organizations positively identify all nonconforming products, and really smart organizations segregate them to remove all chance of accidental use. Error-proof your control of the nonconforming product process so that assumptions don’t have to be made.

5. Failing to use the corrective action process

Corrective action is the systematic way to investigate problems, identify their causes and keep the problems from happening again. Nobody wants problems, but it’s essential to have a way to deal with them when they come up. The more the corrective action process is used, the better the organization gets at addressing its risks and problems. An effective corrective action process is typically seamless, simple and intuitive. Actions developed correctly add a little structure to problem solving and don’t create additional bureaucracy.

6. Applying document control only to official documents

Most organizations do a decent job of controlling “official” documents: the procedures and work instructions that form the core of the quality management system (QMS). These are often written, approved and issued according to very specific guidelines. What organizations don’t do very well is control unofficial documents, many of which are more important than the official ones. These may be memos that include procedural steps, Post-it Notes with special requirements, emails with customer specifications, and many others. These informal resources become documents when they’re shared for people to use, and they’re some of the most important documents within an organization. Apply document control to all documents, and scrutinize your document control process to keep it streamlined and effective.

7. Focusing audits on petty, nonstrategic details

Auditing is the process of comparing actual operations against commitments the organization has made. It’s a simple, fact-driven process that can generate huge improvements. However, these improvements happen only if auditors focus on the right things. Too often, internal auditors become preoccupied with petty details and neglect the big issues. They’re uncomfortable examining the big, strategic issues. It’s important for your organization to provide training and skill-building to your internal auditors to avoid these common pitfalls.

8. Training some personnel, but not all

Most organizations provide significant training to hourly production personnel. Salaried and managerial personnel are often neglected, however. Why? Because there’s a perception that salaried workers don’t affect product conformity. This is a serious error. All personnel must be included in the training process. Salaried and managerial personnel need more—not less—training because their decisions and actions have larger and more lasting effects. When an hourly employee makes a mistake, it could cost money. When a top manager makes a mistake, it could put you out of business. Train your employees early and often.

9. Doing anything just because an external auditor told you to

In my travels to companies, I often ask people why they’re carrying out a process the way they are. I always raise this question when the process seems unwieldy or illogical. In a surprising number of cases, the answer will be, “Because the external auditor said we should do it that way.” Before you jump into any recommendation, conduct a reality check to make sure it makes sense for your organization.

10. Employing someone who only oversees the QMS

Having a person who does nothing but oversee the ISO 9001 (or any other) QMS is not a good
idea as it guarantees two things:

First, the QMS coordinator will become isolated from the rest of the organization.
Because the person does nothing but serve the QMS, he or she loses touch with why
the organization exists and what the organization’s objectives are. The system becomes
paramount over the organization’s business concerns.
Second, the QMS will become bloated and bureaucratic because it must expand to
completely fill someone’s time. Procedures become more complicated, methods more
cumbersome and the benefits more ambiguous.

A quality management system needs to be a streamlined and simple engine for success. Instead of being an adjunct to the way an organization conducts business, it needs to be The Way business is conducted. Weave the system into the day-to-day flow of activities and watch it produce results.

And by all means learn from the mistakes of others.

By: Craig Cochran, Project Manager, Georgia Manufacturing Extension Partnership