So, you’ve just finished with your audit. And you’re beyond tired. You’re drained. The auditor asked for a report for January 3, second shift. And to see data collections missed for the week of February 4. And more. So many detailed and specific questions. And so many spreadsheets. And too much collating and digging. Audits are often challenging for manufacturers, instilling a mixture of anxiety, stress, and frustration that together produce audit fatigue.
Most quality professionals are tasked with preparing for an audit while still overseeing the daily demands of safety guidelines and compliance with regulations and industry standards. Audits also take manpower, sequestering some of your best people in a room for days as they dig and sift through data.
Audit fatigue is real, but a solid, robust quality management system can take the stress out of audits by doing the hard work of retrieving records and production data for you. With a cloud-based quality intelligence solution like those from InfinityQS, data is stored automatically and easily accessible.
Digital Transformation for Manufacturers
Audit fatigue is the result of a number of contributing issues. First is the use of paper reports or manually updated spreadsheets. While these solutions often seem “free” because they’re already paid for or come preloaded on your computer, they can’t deliver the ease of use and time-saving power of a modern statistical process control (SPC) system.
The events of the past year have served to emphasize the problems with using paper or spreadsheets as the basis of a quality system. Paper and spreadsheets don’t give you the ability to centrally store operations and compliance data, and they make it impossible to quickly retrieve the information you need. What you need is an SPC solution that can get you the reports you want in seconds.
For manufacturers, digital transformation begins with replacing manual reports and processes with automated systems designed to work round the clock and generate useful, standardized data. Implementing a quality management system as part of your digital transformation will help you ensure that your company is always operating within compliance. This real-time visibility, in combination with streamlined reporting features, significantly reduces audit time.
Cloud-based quality management solutions—like the Enact® Quality Intelligence platform from InfinityQS—ensure compliance while offering the added benefits of cost savings, reduced waste, and improved overall product quality. Leveraging the power of the cloud can take you from audit fatigued to audit savvy and relaxed.
When Things Go Wrong
When (not “if”) things go wrong, InfinityQS can help take the edge off the audit process.
With an audit, 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 use technology solutions to ensure consumer safety and to protect their brand image. Having the data you need readily available allows you to focus on addressing the extenuating circumstances that allowed a defective product to slip through to a customer.
Manufacturers with enterprise quality systems, especially those with a centralized data repository like Enact, gain traceability throughout their supply chains. Centralized data makes it easier to identify the exact products that might be affected by a recall and enables the creation of the reports you need to quickly identify which products are affected and where they were distributed.
Another advantage is traceability. Modern quality intelligence solutions let you precisely track a defective product, tracing raw materials through the manufacturing process all the way to finished goods. You can tag manufactured products with production data (line, shift, operator) and supplier data (name, date, inspection). Then you can quickly find and dispose of defective or recalled products before they ship and be precise about which products to pull off shelves, saving lots of time and money.
Software as a Service (SaaS) is a Great Answer
Plenty of manufacturers have quality systems that they’ve “cobbled together” over years (or even decades). Many manufacturers use a mix of paper, spreadsheets, and on-premises software products. These systems can differ from one plant to the next, resulting in non-standardized data and misaligned priorities within the same company. Facilities that use custom data collection systems face the challenge of having data in disparate formats, which prevents them from integrating with other systems. In the end, this makes the reporting process during an audit extremely time-consuming.
Cobbled-together quality systems do a poor job of supporting audit tasks because they don’t centralize and organize your quality data. Alternatively, cloud-based quality systems leverage a Software as a Service (SaaS) model to provide a single repository for all data across an enterprise. InfinityQS customers can use their powerful cloud-based SaaS platform to collect data from different devices and systems. With this flexibility, companies don’t need to invest in additional hardware, nor replace what they already have on the shop floor or in laboratories.
With manually updated systems, answering an auditor’s questions can take days or even weeks. For many customers, portions of their data are simply inaccessible or consist of hand-written numbers that are difficult to interpret. This makes reports nearly impossible to generate. However, with a cloud quality management platform, data is stored and processed in a centralized data warehouse that can be accessed from almost anywhere.
With the right tools, you can confidently complete even the most strenuous audit instead of succumbing to audit fatigue. Auditors also appreciate the simplicity, speed, and efficiency of cloud-based audit reporting. They ask their questions, and the answers are just a few clicks away.
What’s YOUR Audit Plan?
Creating your audit plan requires just three steps:
- Create a plan for compliance
- Prove the plan works
- Control the impact when things go wrong
Create a Plan for Compliance
Compliance hinges on making reports available to the right people at the right time, ensuring information is up to date, and obtaining the right signatures from management. Relying on people from across different departments to control all aspects of the system can lead to missing documentation, 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. Without it, operators can’t immediately correct an issue before a large amount of bad product is produced—or worse, shipped to customers. Collecting data on paper means a wait of hours, days, or weeks for accurate reports to find out whether processes ran correctly. That’s time you don’t have.
Prove that Your Plan Works
If an auditor requests to review a three-shift time period and your team of quality pros can only find the paperwork for two of the shifts, you’ve got a problem. Proving that your audit plan works means being prepared to answer these kinds of specific, in-depth questions. The way to do this accurately and efficiently is with 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.
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—with a centralized data repository—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 centralizes data to enable the creation of the reports that are necessary to control the impact when things go wrong.
Fight Audit Fatigue with Data
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.
If you are overwhelmed with compliance and audit tasks, it’s time to accelerate your organization’s digital transformation—and moving quality management to the cloud is the first step. InfinityQS is here to help. Please visit us to learn more about how the power of the cloud can transform your manufacturing operations.