For manufacturing organizations across industries, audits are a source of anxiety, stress, and frustration. And as the number of safety regulations grows, quality professionals are spending more time and energy preparing for audits—while still juggling the daily demands of safety guidelines and compliance with regulations and industry standards. Centralizing critical quality and process data in the cloud dramatically reduces the pain of audits.
Problem One: Bringing Info Together
The repercussions of failing an audit can range from detrimental fines to extended suspensions. The pressure of an audit is often compounded by the fear of being unable to produce the necessary documentation to prove compliance. And, unfortunately, many manufacturers struggle to locate, compile, and present requested data—sometimes covering a vast time frame—within the allotted time constraints.
The problem is that many legacy quality systems have been cobbled together over time using paper checklists, spreadsheets, custom data collection systems, and on-premises software products. And those systems might 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—even impossible. Without a way to bring quality data together, most cobbled-together quality systems are a mess, and they do an abysmal job of supporting audit tasks.
No wonder audits hurt so much. And auditors ask lots of questions and require lots of data. To effectively answer auditor questions, you might need hours, even days (sometimes even weeks!) to get your staff together and figure out how to lasso all that data the auditor is seeking.
But there’s hope. Cloud-based manufacturing quality software—offered as Software as a Service (SaaS)—brings it all together.
Need Fast Access to Audit Data? Centralize It in the Cloud
Cloud-based 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.
When all the information you need is in one place—and your software provides the intelligence to create custom reports in real time—audit time is reduced from weeks to mere hours.
Create an Intelligence-driven Audit Plan
Manufacturers need to take advantage of the latest technological advances to reduce risks and ensure compliance at every step and in every manufacturing process. Cloud-based quality platforms can ensure compliance while offering the added benefits of cost savings, reduced waste, and improved overall product quality.
To ensure a smooth auditing experience, break down your audit preparation into three components:
- Create a plan for compliance
- Prove the plan works
- Control the impact when things go wrong
1. Create a Compliance Plan
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. With legacy, siloed systems, that assurance can be challenging.
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 a lack of real-time visibility into production data. Without a view into what’s happening on the line, operators can’t correct 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.
2. Prove the Plan Works
Many manufacturers have difficulty proving whether checks have been completed, especially when data across systems, plants, and shifts is hard to find.
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. Instead, just sit down at a computer and quickly and easily pull up reports and data that answer the auditor’s toughest questions.
And you can easily customize reports to provide specific answers to 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 auditors appreciate getting the information they need in a timely fashion.
3. Control the Impact When Things Go Wrong
Regardless of the precautions you take to uphold high quality standards, a defective product can still slip through.
When it does, it’s crucial to accurately document irregularities to ensure that all the proper steps were applied. And it’s vital that you have a fast and efficient means to identify, trace, and locate any problematic products.
Manufacturers with enterprise quality systems, especially those 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.
Centralized data enables you to create reports that help quickly narrow the scope of affected products and where they were distributed.
Precisely tracking a defective product is possible with 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). You 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 even before they arrive.
Do You Have a Plan?
If audits are creating major stresses on you and your processes—for weeks on end—it’s time to do something about it.
InfinityQS quality solutions are here to help. Take a few minutes to learn how our cloud-based quality platforms can 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.
Go beyond audits to improve quality every day.
Learn more about how InfinityQS solutions enable true visibility and performance improvements across processes, lines, and plants.