Tag Archives: quality assurance

Gina Kramer
Food Safety Think Tank

An Introduction

By Gina R. Nicholson-Kramer
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Gina Kramer

This new column on Food Safety Tech is a B2B forum for food safety tech, food manufacturing, food distribution, food retailer service/sales, and chemical and tools manufacturing companies in our industry. One of the important efforts we all have in common in this industry is we must continually identify food safety risk (or gaps) in food manufacturing, distribution, and sales to develop improved systems, methods, chemicals, and tools to fill these gaps and reduce risk. In the near future, many of these efforts will be mandatory due to the new regulatory rules being developed through FSMA.

Food Safety Think TankMy goal for this column is to facilitate new thinking to stimulate innovative solutions in food safety for our industry. I have the experience of leading large chain food sales and food service food safety programs; working with business professionals within our respective food companies and with our vendors, to develop systems and tools to improve food safety.

How can this column be of value to our industry?

  • Follow the column. Subscribe to FST News, and receive notifications of the column in your inbox whenever we post something new.
  • Participate. The column should be more than just a source for useful information; I actually want to start a conversation with you – industry professionals. Respond to column posts and share what you know, ask questions, submit ideas, inform us of gaps you see in food safety, and share your efforts, etc.
  • Contribute. We are actively looking for industry professionals who want to share their work in food safety. Whether it’s benchmarking existing solutions or sharing your research that defines gaps and new opportunities for innovation, we need your contributions. Let’s invoke a broad range of new ideas across a wide range of issues to speed up new or improved tools, reduce cost, improve efficiency, and even develop new business models for food safety solutions. Write to me at Gina@SavourFoodSafety.com. I look forward to hearing from you. 

How to Run an Audit-Ready Co-Pack Operation

By James Houghton
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If an auditor were to walk through your site today, would you be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client?

I think many of us have once been – or are still – in a state of scurrying around right before an auditor knocks on our front doors. When you’re small and growing quickly, it’s hard not to be reactive for things like regulatory audits. But at some point, you have to proactively build out repeatable processes to drive long-term growth, and start really taking control of your own operation.

Here’s the ideal:

You want your co-pack operation to be in a state of audit-readiness. That is, if an auditor were to walk through your site today, you’d be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client.

Earlier in October, I presented a webinar on “How to Run an Audit-Ready Co-Pack Operation,” i.e., how to get your house in order. Here are the five pillars of maintaining a state of audit-readiness for your co-pack operation:

Culture

In the same way that you have built a culture of collaboration and client satisfaction you’ll also need to build one for Quality. The way you prioritize and permeate Quality initiatives throughout the organization, from your senior team to your shop floor staff, will show when the auditor walks through the doors.

Paperwork

It’s vitally important that your paperwork is in order, including your SOPs, transactional items like RFQs, POs, and SOWs, and most importantly, the batch record. The auditor will be looking for two things amongst all of your documentation: content and consistency. The content needs to meet regulatory requirements, and there needs to be consistency between what you say you do and what you actually do.

It’s not rocket science: you need to write out what you do, and then you have to do the activities that reflect what you’ve written down. This is often the one thing that won’t be maintained properly, unless it’s given attention.

Physical Space

Your physical space will be audited to ensure it’s set up with the correct flow, that it is kept clean, and there is documentation to that effect.

To make sure your physical space is up to par for an audit, imagine that you yourself are the product… go back to your receiving doors and physically walk through your facility, as a “day in the life” of your product. You’ll be able to see where you go, how you are handled, and where each step is documented. Along the way, anything that’s not delineated, not treated or identified properly, or does not follow a logical flow, are the areas you need to lock down before an audit.

Material Control

An auditor will want to see that you’re in control of your materials, and that you have track and traceability. Being able to track where you’re storing things in the site, where it’s moving, what your processes are for moving inventory, etc… all that demonstrates that you have the traceability controls to be able to handle mock and real recalls and maintain consumer safety.

Production

Ahh… the production line. It’s where the magic happens. When setting up your production line, you need to make sure you have appropriate line clearance, the lines are segregated, the correct staff are on the line to do the project, and that they have had the proper training for their particular activity in the line. In the co-pack world, where things are highly customized with low repeatability, it can be easy to overlook the extensive amount of training it takes to make sure each production line is in good hands. You need, however, to make sure you do your due diligence to maintain production accuracy, quality assurance, and regulatory standards.

In the webinar, I discuss each of these areas in greater detail. If maintaining a state of audit-readiness is an endeavor you’d like to pursue, watch the webinar for more details or access the slide deck by clicking here