So, you’ve just finished with your audit. And you’re bushed. Beat. What an ordeal! The auditor wanted what? To see a report for January 3
rd, second shift? To see data collections missed for the week of February 4
th? And more. So many questions. So detailed and specific. And so many spreadsheets and too much collating and digging.
Audits can be exhausting. They are often challenging for manufacturers, instilling a mixture of anxiety, stress, and frustration. Resulting in “audit fatigue.” As the number of safety regulations grows, the probing questions and unsolicited advice are just the beginning for most quality professionals. Much of their time and energy is spent on the daunting task of preparing for an audit while still overseeing the daily demands of safety guidelines and compliance with regulations and industry standards.
Oftentimes, audits take too much manpower. They last too long. They cost you. Sometimes you have to take your best people, sequester them to a room for days, digging and sifting through data to find what the auditor needs. A solid, robust quality management system can handle that for you. There’s really no need any more for you to suffer “audit fatigue” anymore.
InfinityQS quality management systems are here to help.
The Digital Age is Here
Audit fatigue is the result of a number of symptoms. First and foremost is use of paper reports or spreadsheets. As your quality doctor, I’d like to first recommend, if you’re still using paper or spreadsheets, that you stop. Using paper or spreadsheets is a direct result of not taking advantage of available technology, not harnessing the power of a modern statistical process control (
SPC) system.
Our COO, Doug Fair, a life-long statistician and quality expert, stated very clearly in his
blog series for quality professionals, that “Organizations shouldn’t use paper or spreadsheets as the basis of their quality systems. Neither paper nor spreadsheets should be used to collect data on the shop floor. Neither of these solutions will give you the information you need. What you need is an SPC solution that can get you the reports you want in seconds. It’s time to throw away the paper and move into the digital age.”
InfinityQS Solutions
Given today’s technological advances, audit pain and fatigue can be significantly reduced with the implementation of quality management software to ensure compliance in the first place. These systems make reporting a snap and help significantly reduce actual audit time.
Quality management solutions—like
Enact® and
ProFicient™ from InfinityQS—can ensure compliance while offering the added benefits of cost savings, reduced waste, and improved overall product quality. They can take you from audit fatigued to audit savvy and relaxed.
When Things Go Wrong
When things go wrong (notice I did not say “if”—and they will, they always do, regardless of our high-quality standards), InfinityQS can help take the edge off the audit process and the stress associated with the extenuating circumstances that allow a defective product to slip through your grasp and into a customer’s hands.
“With an audit,” says Doug in his
Manufacturing Challenges blog series, “it is crucial to accurately document irregularities to ensure that all the proper steps were applied. It is vital that manufacturers have a fast and efficient means to identify, trace, and locate any problematic products. Today, companies utilize technology solutions to ensure consumer safety and to protect their brand images.” That’s where we come in.
“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.”
Traceability
“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),” says Doug. “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.”
Bringing All Your 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. Let’s face it, auditors don’t have time, you don’t have time. Manufacturing is a fast-paced industry. When the need for an audit arises, both sides want to get it done as quickly as possible.
And the repercussions of
failing an audit can range anywhere from crippling fines to drawn-out 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 Great Answer
Plenty of quality systems have been “cobbled together” over years, even decades. And lots of 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 disparate data formats, custom systems do not really “talk” to each other, and in the end this makes the reporting process during an audit extremely time-consuming and darned near impossible. Without a means of coordinating all of your quality data, most cobbled-together quality systems are a mess, and they do not do a good job of supporting audit tasks.
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. InfinityQS SaaS systems don’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. You therefore have no need to invest in additional hardware, and no need to replace what you already have on the shop floor or in your 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 all your audit and reporting needs.
To effectively answer an auditor’s 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 consists of hand-written numbers that are difficult to interpret; reports are therefore nearly impossible to generate. That’s no way to function, and it’s no way to manage an audit. No wonder so many of us get so audit fatigued.
Audit Time Should Not be Worrisome
Steve Wise, InfinityQS VP of Statistical Methods, once wrote that things can, and should, be different for manufacturers when it comes to audits. In his
blog series for the packaging industry, Steve wrote about his experiences:
“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.”
So, What’s the Plan?
Simply stated, to stave off audit fatigue you need an
audit plan. Your audit plan should include these three components:
- Create a plan for compliance
- Prove the plan works, and
- Control the impact when things go wrong
Create a Plan for Compliance
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 from 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.
You also need 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.
Prove that Your Plan Works
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. Therefore, you need a centralized data repository.
A centralized enterprise quality management system keeps together all the 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.
And reports can be customized to provide very specific answers for the most challenging auditor inquiries.
Control Impact
Defective products slip through; it’s a fact of life in manufacturing. An audit requires you to accurately document irregularities to ensure that all the proper steps were taken. It is vital that you have a fast, efficient, reliable means to identify, trace, and locate any problematic products.
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.
InfinityQS centralized data enables the creation of the reports that are necessary to quickly narrow the scope of affected products and where they were distributed—controlling the impact when things go wrong.
In Closing
Audit fatigue can prove challenging for anyone, in any industry. Audits may instill a sense of fear or frustration and a heightened level of anxiety. You may spend a lot of your time and energy preparing for an audit while you should be ensuring your products’ quality and consistency.
InfinityQS quality management solutions are here to help. We will relieve you of audit fatigue, take the stress and strain out of the 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 any internal needs. Problem solved.
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.