Third-party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.
Does This Scenario Sound Familiar?
A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the QA manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”
So much stress and so much pressure just to get a “good score”. Corporate wants to know what happened before the auditor even leaves the plant. Performance evaluations, raises, year-end bonuses and sometimes even jobs are at risk. It’s no wonder people worry about audits so much.
What if I told you it doesn’t have to be that stressful? It doesn’t if you implement some of the things I have learned over the years.
What Is an Audit?
I informally define an audit as verification that things are being performed to established rules. Those rules can be a customer contract, an audit scheme such as SQF or government regulatory standards. For this article, we are going to talk specifically about independent third-party audits.
Who Is an Auditor?
An auditor is a person.
It’s easy to forget sometimes. They are people with their own story, training and experience. They may be a retired QA director from a major food company with decades of experience. They may be a former plant QA manager in the automotive industry with no food experience. This may be their first audit. They have a story and that will influence your audit.
Few people know that you can choose who audits you. Make sure the person who is coming in to evaluate your plant has the right experience and temperament to work with you. Ask the audit company to provide you with three to five resumes of auditors that they would like to send to your facility. Arrange for interviews with them and choose the one that fits best. You are looking for the right mix of experience and temperament. You don’t have to take who they want to send.
What Is an Audit About?
An audit is an answer to a series of specific questions and how you meet them. This is key to how you should approach an audit. The PDCA model is an ideal way to remember this point (see Figure 1).
A new industry survey is highlighting several issues facing food safety and quality assurance professionals, from employee retention to understanding the final FSMA rules. The 2016 Annual TraceGains Food Safety & Quality Assurance (FSQA) Professional Survey digs into the top priorities (FSMA compliance, audit readiness, supplier relationship management, etc.) of professionals and sheds light on some of the current challenges that companies are facing, especially in the area of compliance, FSMA readiness and supplier documentation.
“We’re seeing a recipe for stress in the food and beverage industry: Take one-part low margins, blend in one-part increased government regulation, one-part unannounced audits, one-part increasing customer demands, and one-part manual paperwork,” says Gary Nowacki, CEO of TraceGains. “Mix well, bake on high, then spread thinly with a limited pool of FSQA professionals.”
Nearly 500 FSQA professionals participated in the survey. In a two-part Q&A with TraceGains, Anthony Arocha (customer success consultant), Rajan Gupta (vice president of customer success), and Jason Ulrich (customer success manager) explain what the results mean in to the broader industry.
Food Safety Tech: Were there any surprises with this year’s survey?
Anthony Arocha: FSMA compliance is across the board a top priority with staffing/training as one of the biggest obstacles to overcome. I would say this is a huge opportunity for automation to help reduce the risk and long-term costs incurred by the increasing demand for accurate documentation.
Rajan Gupta: I do not think there are any surprises but a very strong restatement that FSQA staff is difficult to hire/retain due to limited individual growth, low salaries, inadequate training, incentives, etc. All of these lead to the fact that most food companies look at food safety and quality as a nuisance that they must deal with versus as a function that is a necessity or a requirement with adequate funding.
FST: With FSMA being a top priority among survey respondents, are you finding that companies are concerned about any of the rules in particular?
Arocha: Honestly, it seems that most folks are trying very hard to get a handle on all the new rules and what their responsibility is for compliance. Not sure they have gotten to the point of having just one or two main concerns yet. There is more emphasis on creating strong relationships with the downstream and upstream customers and suppliers than ever before. Some of the rules seem vague, which will require an operation to be prepared to support how they meet a particular requirement or may be potentially exempt from it. These have been some of the concerns that seem to be popping up most.
Gupta: The main theme that we hear from our customers is that there is confusion. Companies have had to deal with many requirements in the past, some of which conflict each other. I think lack of a thorough understanding of food safety within an organization is a key limiting factor to truly determine what is needed at each organization to meet FSMA guidelines.
Jason Ulrich: Companies are concerned about FSMA. Most are concerned with FSMA as a whole. Many have taken steps to educate themselves, but the law is vague, especially for companies that are in multiple areas of food manufacturing.
In America’s food supply chain, food is sourced globally. Since ingredients often come from multiple countries, inspection and quality control is challenging, as regulations, policies and processes differ in each country. Product management begins with the suppliers, from the fields where the foods are grown, to the pesticides and fertilizers used, to harvesting, washing, shipping, storing, and processing (manufacturers), and finally, to packaging and delivery to consumers.
Figure 1 shows each step of the product management process can introduce contamination due to unsafe practices or other risks. As such, test data and traceability must begin in the field and end when the final product is delivered to the consumer. The Laboratory Information Management System (LIMS) captures all information to ensure that quality data is effectively managed, communicated, and easily and quickly accessible in the event of a contamination issue. The LIMS allows producers to provide authorities with the required sampling and testing documentation to prove compliance.
U.S. consumers expect their food products to be affordable, consistent, safe and unadulterated. Consumers have seen numerous food recalls in the news, and it has shaken their confidence. The CDC estimates that about one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and approximately 3,000 die of foodborne diseases each year. Global food directives for international food initiatives include CODEX, ISO (International Standards Organization), and the Global Food Safety Initiative (GFSI).
The U.S. Government has implemented various food safety programs, from Hazard Analysis & Critical Control Points (HACCP) to FSMA in order to identify and correct potential contamination in the food supply. In fact, one of the primary focuses of FSMA is preventive action based on risk assessment.
The food landscape has changed significantly, especially over the past decade, as consumers demand year-round fresh fruits, vegetables and juices, along with more exotic foods. The fact that U.S. food is globally sourced has resulted in numerous challenges in quality assurance, shipping, traceability, labeling, storage, blending, testing, and reporting.
For example, upon reading the labeling on an apple juice can, it is not uncommon to learn the juice has been possibly sourced from numerous countries including the United States, China, Brazil, Argentina, Chile and many other countries from the European Union. Oftentimes, labels state that ingredients may come from some of the countries listed, but it does not specify what percentage comes from each country or exactly from which country the product was sourced. Figure 2 shows how LIMS can track and manage this information in a relational SQL Server LIMS database.
A similar scenario is true for tracking hamburger meat: The meat that was used to make burgers can come from multiple ranches and hundreds of cows. Many consumers don’t understand why their food/beverage is blended in large ton batches, and producers want to reach the required final product specifications, while offering a consistent product and experience to the consumer. Blending has become commonplace in the food industry, and it makes traceability much more challenging. The same is true in blending different meats, for example regulators have found pork in products marked 100% beef, this has led to the use of molecular tests to determine if meat has been adulterated.
FSMA and Traceability
FSMA focuses on a preventive approach rather than reaction and response to foodborne outbreaks. A central focus is on traceability, involving a complete understanding of the complex food chain and conducting testing at the key control points that can introduce contamination. It is important to understand the source of all the raw ingredients that make up a final product as well as the details of where they are sourced, the CoA (Certificate of Analysis) report, other test results, and all associated documentation. These elements are especially important, because each region of the world has different approved testing methods and is challenged with different potential contaminants and processes. As a result, food manufacturers must manage a significant amount of information on all raw materials that they receive, along with the associated paperwork, which includes the CoA, confirmatory test data, and all plant, production and final product test data.
Case example. As operations scale, so does the testing. In order to manage all the testing, most laboratories turn to LIMS and laboratory automation to manage high throughput screening. A client that was performing nearly 1,000 Listeria tests per day was using an automated microbiological screening platform to complete this testing. They were struggling to hire more resources to manage and run the instrument, as the time was short and the increased sample volume was imminent. The goal was to automate testing from the nine plants that were submitting samples to the main laboratory, such that the entire process could be automated from the laboratory knowing how many samples were coming from each plant and from deploying pre-configured worklists to upload to the instruments. The instruments would then run the samples and send the result back into the LIMS. This integration alone saved more than six hours per day. In addition, the electronic data transfer was fast and error-free, and since the data was imported into the LIMS, any positives were automatically flagged in real time. This approach allows immediate action.
In addition, all data from shelf life studies and additional testing on the food product (i.e., pesticide testing, environmental testing for Listeria sp., mold, yeast, etc., formulations, and blending) can be managed in the LIMS, one centralized database.
How LIMS Supports FSMA
Over the years some manufacturers have relied on less-robust tools to manage and maintain testing data, from multiple Excel spreadsheets to paper log books. Challenges with using these tools include data corruptions, data loss, typographical errors, and accidental or malicious data changes. These systems are often costly, especially from a resource standpoint (i.e., data errors, hours spent interacting with the data for calculations, tracking samples, and manual report creation alone). In addition, creating reports for regulating authorities can be time-consuming and because there is no control over changes to the Excel sheets or logbooks, there is typically no audit trail, and because the data is not in the database, querying the data can be very difficult.
A quality LIMS will ensure that the organization is bullet-proof when it comes time for regulatory audits. It also provides a complete and secure solution to manage, track and monitor batches of product from farm to table. LIMS not only helps clients manage their regulatory compliance goals, but it also facilitates communication across the organization and provides laboratory intelligence that gives buyers insight into the best suppliers to purchase from, based on final product specification, consistency and pricing. Managers can also better understand when it is time to outsource testing based on workload data, allowing them to maximize their resources and profitably through more efficient operations. The system also accelerates communication: As soon as testing is completed, reports can be automatically emailed and alerts sent to cell phones, if any issues arise.
When dealing with perishable products, time is of the essence, LIMS save time. Table 1 lists just a few of major benefits of the LIMS in FSMA regulatory compliance.
Sample tracking and management
Integrated barcode support (both 1D and 2D), manage all batch data, tests, from raw materials, in process testing to final packaged product testing
21 CFR Part 11
Compliance with electronic signature requirements
Easily, automatically generate the CoA report once testing is completed, validated and approved
Manage final product, supplier and customer specifications and pricing
Link all paperwork to Work Order for ready access and retrieval
Full Chain of Custody
Automatically generated and linked to the order
Records data and all paperwork associated with product
All paperwork that arrived with the raw ingredients, CoA, and shipping documentation or additional test data
Records all test results
Automatic data import from instruments as well as hand entered data
Setup, manage and track all aspects of shelf life studies
Formulations and Blending
Manage and track as components and specifications for final product blends, and leverage predictive tools for optimal purchase options from suppliers
Track actions in the system and generate a report of all audits made to any result data
CAPAs (Corrective and Preventative Actions)
Track and manage open CAPAs in the LIMS, and tie to testing results for easy management to increase customer satisfaction
Traceability back to the source (farm, country) and forward to the store that it was shipped to, with key data (lot number, ship date, etc.)
Users can view all components and associated test results, along with any notes on the final product, back to the supplier and forward to locations that offer the product to the consumer
Manage employee training records and view Standard Operating Procedures online to ensure access to work instruction and provide evidence for audits
Manage all quality control data on the instruments used in the testing, as well as documented calibration data, maintenance, any repairs, or any issues. Users can link the PDF manual in the LIMS
Enterprise integration (ERP, SAP, SCADA, MES, SAS JMP)
Data sharing allows users with permissions access to data when they need it, so that they can quickly view and monitor information they need to perform their job. Users can also view data with integrated statistical tools to view trends that may not be readily evident
A LIMS is a critical tool to the success of food companies. It organizes and securely manages all aspects of food testing, facilitates regulatory compliance, enhances communication within the organization, and maximizes productivity. Many food producers are concerned about protecting their brand and providing a high quality, consistent, and safe product to consumers while operating efficiently and at a profit. An LIMS allows them to meet these goals.
Achieving complete traceability is a must to combating seafood fraud. How is industry getting there?
The length and complexity of the seafood supply chain has created an ideal environment for fueling the mislabeling of the world’s most highly traded food commodity. Considering 91% of all seafood consumed in the United States imported, the ethical and economic impact of seafood mislabeling is enormous. While increased demand is putting pressure on the seafood industry, federal agencies are laying the groundwork to aggressively attack the rampant mislabeling problem.
“Illegal unregulated and unreported fishing is a huge global phenomenon that distorts markets and skews estimates of fish abundance,” said Kimberly Warner, PhD, senior scientist at Oceana, during a recent webinar on food fraud. The goal is to achieve complete transparency and traceability, keeping the “who, what, when, where, and how” with the fish. “Right now when fish are landed, they are required in the United States to list the species, where it was caught, [and] how it was caught. But that information is not following seafood through the supply chain.”
Simply put, seafood fraud is as any illegal activity that misrepresents the seafood one buys. According to Oceana, this can include not disclosing the real name of the fish or its origin, not providing an accurate weight, adding water or breadcrumbs, not declaring the presence of additives, or selling “fresh” fish that was previously frozen.
There are several motivations behind seafood fraud, says Warner. Some businesses want to increase profits and avoid profits; others want to hide illegally caught seafood or engage in trading endangered or threatened species, or mask seafood hazards; and some companies are just ignorant to the requirements of seafood labeling.
The lack of reliable and trustworthy information poses a challenge to consumers who want to make informed decisions when purchasing seafood. While proactive consumers use guides such as “Seafood Watch”, a program offered by the by Monterey Bay Aquarium, in many cases they still do not have enough information to make a decision with complete confidence.
Supply Chain Traceability
Last month the Presidential Task Force on Combating Illegal, Unreported, and Unregulated Fishing and Seafood Fraud released its final recommendations for creating a risk-based traceability program that tracks seafood from harvest to entry into U.S. commerce. The ambitious action plan seeks to tackle the following goals:
• Combat IUU fishing and seafood fraud at the international level • Strengthen enforcement and enhance enforcement tools • Create and expand partnerships with nonfederal entities to identify and eliminate seafood fraud and the sale of IUU seafood products in U.S. commerce • Increase information available on seafood products through additional traceability requirements
Key dates on the plan’s timeline include identifying the minimum types of information and operational standards by June 30, which will be followed by a 30-day comment period; engaging the public on principles used to define “at risk” species by July and releasing final principles and “at risk” species by October 2015; and building international capacity to manage fisheries and eliminate IUU fishing, with an interagency working group developing an action plan by April 2016.
• Red snapper is the most commonly mislabeled fish (up to 28 species were found to be substituted, a large amount being tilapia) • 74% of fish are mislabeled in sushi venues • 38% of restaurants mislabel seafood • 30% of shrimp samples misrepresented • Chesapeake Blue Crab cakes: out of 90 sampled, 38% mislabeled, with 44% coming from the Indo-Pacific region
Statistics generated from studies conducted by Oceana in which the organization gathered seafood samples nationwide.
How can consumers protect themselves?
Warner’s advice: Ask the folks behind the seafood counter where they purchase their seafood from and whether it is farmed or fresh. If you can, buy the whole fish, because it’s harder to disguise when whole. And finally, if the price is too good to be true, it probably is. “Expect to pay more for wildly caught, responsibly fished seafood,” she said.
A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.
Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.
Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.
Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.
Who should perform the RCA?
Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan
CAPA: The process unpacked
A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:
Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
Investigate: Make a plan to research the problem.
Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
The Action Plan: Narrow the list of possible causes.
Implement: Execute the action plan
Review: Verify and assess effectiveness
A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.
In an interview withFood Safety Tech, Barbara Levin, Senior Vice President and Co-Founder of SafetyChain Software, talks about FSQA Enabling Technologies – the Food Safety and Quality Assurance (FSQA) Game Changer, a series of leadership forums, tech talks and executive briefs that SafetyChain has launched this month.
The focus of the series is how technology can help FSQA teams execute to meet today’s biggest food safety and quality challenges in program management, compliance, continuous improvement, risk mitigation and much more.
Food Safety Tech (FST): SafetyChain is launching a new series, called FSQA Enabling Technologies – the Food Safety and Quality Assurance Game Changer. What is the series about and what will it include?
Barbara Levin: For the past three years, working with thought leaders throughout the food and beverage industry, SafetyChain has helped educate and share insights on critical topics – such as FSMA and GFSI. In 2015, we’re excited to bring the conversation to the next level – to discuss the tools that are available to execute on challenges such as FSMA compliance, managing GFSI programs, risk management/brand protection, audit readiness, cost of quality, supplier compliance, operational KPI performance and much more.
FST: Why is technology an important topic in food safety today as we enter 2015?
Levin: I strongly believe that adoption of FSQA enabling technologies is vital, necessary and inevitable – and the only way food companies are going to be able to scale to meet all of the challenges ahead of them. And industry is realizing this and wants to learn more as technology adoption is becoming more mainstream. Think about the technologies we all use at work and home today – things like employee portals to view our paychecks, email, online banking, all of the apps on our computer tablets – none of us can imagine doing without them now. Well think about suppliers entering Certificate of Analysis info on portals. FSQA folks doing pre-harvest inspections on mobile app forms, getting safety and quality information in realtime to determine if there are non-conformances and CAPAs required. And there are hundreds of other examples. We think these will become a way of life too in food safety and quality. So we’re really excited to provide a forum for this FSQA technology conversation.
FST: What changes have we seen in Food Safety and Quality Assurance enabling technologies that are allowing them to achieve more widespread, mainstream adoption?
Levin: There’s a wrong perception that the food industry lags behind some other industries when it comes to technology adoption. In reality, food companies have automated a lot of their functions – look at finance, human resources, payroll systems, supply chain, purchasing, inventory and such. These functions were automated because it saved time, saved money and created operational efficiencies.
Where there was a lag was in adoption of FSQA technologies. I think that this was because first generation safety and quality technologies were behind the firewall – and as we know food safety and quality folks are not sitting at their desks looking at a computer all day. Instead, they are out in the field doing a pre-harvest inspections, or on the plant floor, or at the supplier site doing an audit, or with the customer… basically they are everywhere except at a desk. But today, there are many cloud-based, mobile food safety and quality technologies that can be accessed anywhere, at anytime – and this has really been a game changer when it comes to adoption. Now, food companies are deploying technologies and gaining the same advantages – saving time, saving money and creating efficiencies that improve FSQA.
FST: What are some of the triggers leading teams to explore technology for the first time?
Levin: The word “more” is key to this answer. FSQA is seeing more regulation (think FSMA), more third party schemes like GFSI to manage, more audits, more pressure to improve operational KPIs and reduce the cost of quality. The only thing there’s not more of usually is people – and so technology is the most efficient way to scale to do “more with less.” Additionally technology is the key to getting FSQA information in the fastest manner possible – for timely CAPAs – and be preventive vs. reactive in ensuring that non-compliant products do not go into commerce.
FST: Where do you see FSQA enabling technologies as having the biggest impact on safety and quality operations?
Levin: For me, FSQA enabling technology can have great impact in these areas:
Reducing risk for withdrawals, rejections and recalls;
Having real time and continuous information to generate CAPAs and ensure safe, quality food;
Managing supplier risk and supply chain controls;
Scalability to do more without having to add more people;
Being audit ready – for regulatory, GFSI, customer and internal audits all the time – even for unannounced audits;
Reducing the cost of quality; and
Having actionable data for meaningful continuous improvement.
All of these really come under one umbrella, which is protecting the brand and financial value of your company.
FST: What’s coming up in terms of topics and speakers during the series kickoff?
Levin: The series has three components – Leadership Forums on “big picture” topics, Tech Talks on specific FSQA issues and how technology helps resolve challenges associated with those issues, and executive brief whitepapers on the business side of technology benefits.
The first leadership forum, scheduled for March 13, will feature Bob Butcher, Ipswich Shellfish Company’s FSQA Group Operations Manager, and Jeff Chilton, President of Chilton Consulting Group, and will focus on The Business Case for Food Safety and Quality Technology. Future topics include the Role of Technology in Risk Mitigation and Brand Protection, and Technology as an Enabler to Reduce the Cost of Quality.
The FSQA Tech Talks kick off at the end of March with the following topics:
March 31 – Tackling FSMA Compliance: How Automation Enables HACCP-to-HARPC migration, FSMA Reporting, Supply Chain Controls and More
April 21 – Harmonizing FSQA – It’s All About the Cloud: How the Cloud and Mobile Technologies Enable Anywhere, Anytime FSQA Data Capture and CAPA Generation
May 19 – Facilitating Continuous Improvement: Enabling Actionable Data for Trending, Benchmarking and Reporting Across Your Entire Operation
FST: Who should attend this series, and how can they get more information?
Levin: Folks from Food Safety, Food Quality, Operations, Legal, Financial, Executive and Information Technology Management from all sectors of the food and beverage industry are encouraged to register and participate in the series. Everything is complimentary and new topics and dates will be announced frequently. We also invite FoodSafetyTech readers to let us know what topics they’d like to see – they can email us at firstname.lastname@example.org.
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.
My 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.
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:
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.
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.
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.
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.
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.