InfinityQS and the Packaging Industry: #2 – Auditing

Steve Wise
By Steve Wise | January 16, 2020
Vice President of Statistical Methods

Fact checked by Stephen O'Reilly

In this blog series aimed at the packaging industry, InfinityQS quality experts like me will be writing about quality in your manufacturing space, the challenges you encounter in mastering the quality issues you face, and how we—and our proven quality management solutions—are here to help. This is the second entry in the series, and today’s topic is auditing.
Audits are a challenge for many industries, and that includes packaging. The audit process instills a sense of frustration, anxiety, and stress in many manufacturing professionals. And, let’s face it, quality pros in your industry spend too much of their time and energy on the sometimes-overwhelming task of preparing for an audit when they should be focused on ensuring your products’ quality and consistency.
Conquer the Audit Challenge

Bring All Your Quality Data Together

Many manufacturers struggle to supply all the data the auditors require in the time allotted to them. It can be frustrating to locate, compile, and present all the requested data—especially when there are time constraints.
And failing an audit can cost your organization. Punishment can range from detrimental fines to extended suspensions, even a halt in production.

Software as a Service (SaaS) to the Rescue

Quality systems are often stitched together—called “custom,” but what they really are is Frankenstein monsters of tidbits of dispersed information. Many manufacturers 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, custom systems do not communicate, and this only makes the reporting process during an audit extremely time-consuming (and sometimes impossible). Without a means of coordinating all your quality data, most make-shift, cobbled-together quality systems are a disaster, and they do a poor job of supporting audit tasks. 
SaaS on Shop Floor 
Cloud-based software—what is known as Software as a Service (SaaS)—brings all your data together, providing a single repository for all the data across your enterprise. Because it resides in the cloud, SaaS includes the added flexibility for managing a wide variety of data collection devices, formats, and technologies. So, there’s no need to invest in additional hardware on the shop floor or in laboratories.
InfinityQS offers SaaS systems—total quality management solutions that can gather the data from your existing systems, keep it all in one place, and support your quality reporting needs. We slay the Frankenstein monster while taking the pain out of the audit process.

Auditing Pain

Auditors ask a variety of questions, and you never know what they might want to see. In my experience, manufacturers who rely on paper and pencil systems answer auditor questions in the worst possible way: “Gee…that information is scattered across several systems. I think I’ve got some of it over here in this filing cabinet and I know there’s some in the quality manager’s office. The rest of it is probably in…the warehouse.”
Uh-oh. No wonder audits are so painful. To effectively answer the auditor’s questions, many companies request additional time to get their staff together to figure out how to bring together all the data the auditor request. It’s easy to see why audits can take days, or even weeks, to complete.
Make Audits Easy

Audit Time Should Not Be Worrisome

I worked with a company for whom an average audit always took more than a week to complete. After using our quality management software, full audits took less than a day, most times just a few hours. The auditor asked pointed questions, requested specific data…and our customer just opened the software and created a report for all the data related to the requests. It was fast and simple.
Auditors appreciate the simplicity, speed, and efficiency of computer-based audit reporting. They ask their questions, and the answers are just a few clicks away.

Your Audit Plan Should Include Total Quality Management

Packaging manufacturers need to take advantage of the latest technological advances to reduce the risks they face and to ensure compliance at every step of their manufacturing processes. Our quality management systems—Enact® and ProFicient™—ensure compliance while offering the added benefits of cost savings, reduced waste, and improved overall product quality.
To ensure a smooth auditing experience, we at InfinityQS recommend that packaging 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

Creating a Plan for Compliance

The first component necessary to achieve audit-readiness is to ensure compliance. While this may seem obvious, maintaining compliance has become more difficult than ever.
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.
As we all know, 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.
Audit Plan 
Another potential problem is the lack of real-time visibility into production data. This prevents operators from immediately correcting an issue before a large amount of bad product is produced—or worse, shipped to customers. Collecting data with pen and paper means a wait of hours, days, or weeks for accurate reports to find out whether processes ran correctly. Time you don’t have.
The cumbersome, untimely reports you inevitably produce don’t allow your team to verify that proper procedures are being followed until it’s too late—when bad practices have occurred or have become habitual.

Prove the Plan Works

Many manufacturers have difficulty proving that their scheduled checks have been completed. 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 management 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.
Data Available Everywhere 
And reports can be customized to provide very specific answers for the most challenging auditor inquiries. For example, you can create an exceptions-only report, which displays records that identify alarms, events, assignable causes, and corrective actions. The versatile options included in a custom report give a clear, side-by-side comparison of the facility’s plan against checks for compliance and are appreciated by auditors because they provide the information they need in a timely fashion.

Control the Impact When Things Go Wrong

Despite our best efforts to always meet high-quality standards, there can still be extenuating circumstances that allow a defective product to slip through. It’s just a fact. An audit requires you to accurately document irregularities to ensure that all the proper steps were applied. It is vital that you have a fast, efficient, reliable means to identify, trace, and locate any problematic products.
Packaging manufacturers with enterprise quality systems, especially those with a centralized data repository (like InfinityQS 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.
Enterprise Quality System 
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 are even shipped to you.

In Closing

Audits can prove challenging for anyone, not just for the packaging industry. They may instill a sense of fear or frustration and a heightened level of anxiety. A lot of your time and energy may be spent on preparing for an audit while you should be ensuring your products’ quality and consistency.
InfinityQS total quality management solutions are here to help. We will take the stress and strain out of the audit process, help make you more compliant than you’ve ever been, and enable you to easily generate reports that you can use for audits, customers, or internal needs.
So, please return to this blog section of the InfinityQS website to see the next entry in this series designed just for the packaging industry.  Next up: We’ll discuss the importance of climbing out of the “pencil & paper cave” and into the bright sunlight of technology.

Read other blogs in this series:  
Take advantage of the technology at your fingertips today: contact one of our account managers (1.800.772.7978 or via our website) for more information.

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