Members of the Food & Beverage industry: Welcome to this, the fourth entry in a blog series created just for you. InfinityQS quality experts, like myself, will continue to write about quality in your manufacturing space, about solutions to your problems, about the challenges you face in mastering your particular quality issues…and how we are here to help.
Today I’ll be discussing auditing. Audits are a challenge for many industries, and Food & Beverage is no exception. They instill a sense of anxiety, stress, and frustration. And as the number of safety regulations grows, the probing questions and unsolicited advice are just the beginning for most quality pros in your industry. Much of their time and energy is spent on the daunting task of preparing for an audit while juggling the daily demands of safety guidelines and compliance with regulations and industry standards.
Problem One: Bringing Info Together
During an audit, many manufacturers struggle to locate, compile, and present
requested data—sometimes covering a vast time frame—within the allotted time constraints.
The repercussions of failing an audit can range from detrimental fines to extended suspensions. The added pressure of an audit is often compounded by the fear of being unable to produce the necessary documentation to prove compliance.
Software as a Service (SaaS) is a Leg Up
Many quality systems I have seen have been “cobbled together.” Many still use paper, spreadsheets, custom data collection systems, and on-premises software products—and those systems could be different from one plant to the next. Because of their unique data formats, these custom systems do not “talk” to each other, making the reporting process during an audit extremely time-consuming and sometimes impossible. In short, without a means of cohesively coordinating quality data, most cobbled-together quality systems are a mess, and they do an abysmal job of supporting audit tasks.
But there’s hope. Software as a Service (SaaS)—cloud-based software—brings it all together. SaaS quality systems provide a single repository for all data across an enterprise. And SaaS doesn’t care if your data collection devices and systems are all different. Instead, there’s added flexibility for managing a wide variety of data collection devices, formats, and technologies. Therefore, there’s no need to invest in additional hardware, and no need to “rip and replace” what you’ve got on the shop floor or in laboratories. SaaS systems—like the ones we offer at InfinityQS—can gather the data from your existing systems, keep it all in one place, and support your quality reporting needs.
Auditing Pain
I recall the times when we’ve been asked to oversee audits for companies who have outdated technology. Bottom line? It’s painful. And the pain can last for days, even weeks.
You never know what questions the auditor is going to ask or what they might want to see. More times than I care to recall, people looked gut-punched in an audit. Answers to auditor questions typically take this form: “That information is scattered across several systems. I think I’ve got some of it over here in this filing cabinet and some in the quality manager’s office. And the rest of it is probably in the warehouse.”
No wonder audits hurt so much. To effectively answer auditor questions, many people invariably request hours, even
days to get their staff together to figure out how to lasso all that data the auditor is seeking—sometimes for just one question.
And auditors ask lots of questions and require lots of data. You can see why audits take days or weeks to complete. My experience has been that, for many customers, data is inaccessible, or it’s hand-written numbers that are difficult to interpret, and reports are nearly impossible to generate. That’s no way to function, and it’s no way to manage an audit.
Oh, an Audit? No Problem…
I worked with one company for whom an average audit took
more than a week to complete. After using our Quality Intelligence software, full audits took less than
one day. The auditor asked questions, requested certain data…and our customer just opened the software and created a report for all the data related to the request. Pretty simple. An unexpected benefit is that auditors appreciate the simplicity, speed, and efficiency of computer-based audit reporting. Questions are asked, and answers are just a few clicks away in the software.
For organizations that use SaaS quality systems, an answer to an auditor’s data request becomes something like this: “Give me a minute while I query the database and get you everything you need…yes, here we go.”
A Food & Beverage Example
I once worked with a large food manufacturer who called me into an executive meeting. They told me about a quality problem they had with one of their products—a problem that they had missed, which was eventually caught at the
retail level by one of their big customers.
This customer of theirs was unhappy and had requested from them every bit of data for a specific product code for the last 12 months.
They went into panic mode. A team of seven people was formed to find the data and present it in an understandable format. It took that team two weeks and a lot of energy to get it done.
No company can afford to do that. Nor should they have to take seven of their best people to hunt down data for a customer audit.
It should take minutes or (maybe) hours, and it shouldn’t be expensive.
Your Audit Plan Should Include Quality Intelligence
Food & Beverage manufacturers need to take advantage of the latest technological advances to reduce the risks they face and ensure compliance at every step of their manufacturing processes. Our Quality Intelligence systems—
Enact® and
ProFicient™— can ensure compliance while offering the added benefits of cost savings, reduced waste, and improved overall product quality.
To ensure a smooth auditing experience, we recommend that Food & Beverage manufacturers break down their audit preparation into three components:
- Create a plan for compliance
- Prove the plan works, and
- Control the impact when things go wrong
Create a Plan for Compliance
The first component necessary to achieve audit-readiness is to ensure compliance. While this step may seem obvious, maintaining compliance has become more difficult than ever.
The most notable part of new safety standards is the regulatory shift from responsive tactics to preventive measures. Taking proactive measures makes a difference in meeting these requirements. When you have a plan for compliance, there’s no last-minute scrambling and panic to produce data and documentation. To facilitate preparedness, it’s imperative that the proper checks and tests are accurately recorded and completed on time, every time, every day.
Traditionally, compliance hinges on making paperwork available to the right people at the right time, ensuring it’s up-to-date, and obtaining the right signatures from management. Relying on people across different departments to control all aspects of the system could lead to missing paperwork, inaccuracy, and a lack of standardization. For companies undergoing an audit, these irregularities can affect whether you pass or fail.
Another potential problem is the lack of real-time visibility into production data that prevents operators from immediately correcting an issue before a large amount of bad product is produced—or worse, leaves the facility. Collecting data with pen and paper means a wait of hours, days, or weeks for accurate reports to find out whether processes ran correctly.
And cumbersome, untimely reports don’t allow your team to verify that proper procedures are being followed until it’s too late—when bad or even dangerous practices have occurred or become habitual.
Prove the Plan Works
Many manufacturers have difficulty proving whether checks have been completed, and oftentimes handwriting is challenging (if not impossible) to interpret. If an auditor requests to review a three-shift time period, and the quality pros can find the paperwork for only two of the shifts, you’ve got a problem.
A centralized enterprise quality system can easily pull together data needed to verify to auditors that the proper checks, validations, and verifications have occurred, and when they took place. You can display summarized data describing the full story to an auditor—or do a deep-dive into a single shift—all from one computer. Imagine not having to juggle paper any longer. Instead, just sit down at a computer and quickly and easily pull up reports and data that answer the auditor’s toughest questions.
And reports can be customized—these provide very specific answers for challenging auditor inquiries. For example, you can create an exceptions-only report, which displays records that identify alarms, events, assignable causes, and corrective actions. These versatile options give a clear, side-by-side comparison of the facility’s plan against checks for compliance and are generally appreciated by auditors because they provide the information they need in a timely fashion.
Control the Impact When Things Go Wrong
Regardless of the precautions taken to uphold a Food & Beverage manufacturer’s high-quality standards, there can still be extenuating circumstances that allow a defective product to slip through.
With an audit, it is crucial to accurately document irregularities to ensure that all the proper steps were applied. It is vital that you have a fast and efficient means to identify, trace, and locate any problematic products.
Food & Beverage manufacturers with enterprise quality systems, especially those with a centralized data repository (like Enact and ProFicient), gain traceability throughout their supply chains, making it easier to identify the exact products that might be affected by a recall or other actions. Centralized data enables the creation of reports necessary to quickly narrow the scope of affected products and where they were distributed.
The ability to precisely track a defective product is made possible through genealogical reports (tracing raw materials through the manufacturing process, all the way to finished goods) and by tagging manufactured products with production data (line, shift, operator) and supplier data (name, date, inspection). The manufacturer can quickly find and dispose of products before they ship and be precise about which products to pull off shelves, saving lots of time and money.
Such traceability directly supports the requirement for manufacturers to enhance their ability to track and trace both domestic and imported products. Rather than waiting for vendor products to arrive on your loading dock before verifying their quality, shared data with your suppliers and customers gives you visibility into the supply chain—so you know that your suppliers’ products meet your specifications
before they arrive.
In Closing
Typically, audits prove challenging, and not just for the Food & Beverage industry. They may instill a sense of frustration and a heightened level of anxiety. A lot of your time and energy may be spent on preparing for an audit while juggling the daily demands of safety guidelines and compliance with regulations and industry standards.
But InfinityQS Quality Intelligence solutions are here to help. We will take the stress and strain out of your audits, help make you more compliant than you’ve ever been, and enable you to easily generate reports that you can use for your audits, or for your internal needs.
So, Food & Beverage industry members: please return to this
blog section of the InfinityQS website to see the next entry in this series designed just for you.
Next up: We’ll discuss climbing out of the “pencil & paper cave” and into the bright sunlight of technology.
Or, read a previous entry: