Over the coming weeks, a team of InfinityQS quality experts (including myself) will use this blog series as a platform to address many of the challenges that businesses face in today’s high-tech manufacturing world, and how our quality solutions can help you rise above those challenges, exceed expectations, and transform your organization. First up, audits.
Industry audits are challenging for many manufacturers. They instill a mixture of anxiety, stress, and frustration. As the number of safety regulations grows, the probing questions and unsolicited advice are just the beginning for most quality pros. Much of their time and energy is spent on the daunting task of preparing for an audit even while juggling the daily demands of safety guidelines and compliance with regulations and industry standards.
During an audit, many manufacturers struggle to locate, compile, and present requested data, sometimes covering a vast time frame within the allotted time constraints.
It’s enough to make even the calmest of quality pros want to run for cover. But, like the black cat crossing your path, there’s no escape. 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.
But There is Hope
Given today’s technological advances, these risks can be significantly reduced with the implementation of Quality Intelligence software to ensure compliance in the first place. These systems make reporting a snap and help significantly reduce actual audit time.
In this blog, we break down the audit preparation into three components:
- creating a plan for compliance
- proving the plan works, and
- controlling the impact when things go wrong
We’ll also look at how a quality intelligence solution—like Enact®
™ from InfinityQS—can ensure compliance while offering the added benefits of cost savings, reduced waste, and improved overall product quality.
Creating 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.
The Quality Management System
Companies that have taken an enterprise approach to quality are more likely to have the tools and support to stay ahead of the myriad rules and initiatives. A key technology capability to have in quality processes and audit preparedness is the creation and assignment of precisely timed checks to ensure compliance.
But that’s just the tip of the iceberg.
A facility’s specific hazard and prevention control plan creates the schedule of time-based check intervals for each variation of products, processes, or workstations. The reliance on automatic, software-driven prompts ensures that operators collect the right data at the right time. These displays and countdown timers outline all the critical quality checks required at that time. Then, in the event of an audit, a report generated on these timed checks quickly demonstrates compliance; without such documentation, the manufacturer faces a laborious session of pulling paperwork to prove compliance.
Communication protocols should be considered when creating a plan for compliance, as well as the use of technology as a communication enabler. For example, if a failure is detected or data collection is not completed, immediate notifications can be sent via email to support teams, engineering, maintenance, even management. Additionally, operators can be required to specify Assignable Cause (AC) or Corrective Action (CA) codes, providing additional detailed information that can be used to clarify questions during an audit.
For an audit, Assignable Cause and Corrective Action codes provide reasonable explanations for gaps in the records (for when data may not have been gathered) and help to increase credibility. Additionally, the quality team could drill into any events with AC/CA codes to get a clearer picture of what is happening on your shop floor so that further improvements can be deployed.
An enterprise system also brings the data collection points to where the measurement needs to happen and shows results in real time. At the point of data entry, operators immediately know if a product or process is out-of-spec, or noncompliant.
In-system tools like visual alerts or data analysis charts help operators determine whether corrective action is necessary. Identifying problems before an entire batch or lot is completed limits the shipment of affected product and drastically reduces the need for recalls. Because the data has already been entered and stored in a centralized database, procedures for required verification and reporting can be developed with ease.
Proving the Plan Works
As mentioned earlier, manual, paper-based quality and preventive control checks often result in missed checks or lost paperwork. Manufacturers can have difficulty proving whether checks have actually 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, it can prove problematic.
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 let the auditor ask questions as you quickly and easily pull up reports and data that answer their toughest questions.
Reports can even be customized. Customized reports 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 as they provide the information they need in a timely fashion.
User-based records also ensure that the proper checks and tests were completed by the appropriate personnel at the correct times.
Time-based record-retention requirements are simply met with electronic records rather than physical papers stacked in filing cabinets throughout plant offices and storage rooms. Quality pros no longer need to search through mounds of paperwork looking for a needle in a haystack.
And they no longer need to go find the “out of date” paper records and spend time and money destroying them—a time-consuming and non-value-added endeavor.
Controlling the Impact When Things Go Wrong
Regardless of the precautions taken to uphold a 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 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.
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.
Utilizing lot genealogy data, manufacturers can mitigate lost revenue by identifying and salvaging the products that were not part of the tainted batch or lot.
Furthermore, the collected data would provide a governing body with the information necessary to rapidly and effectively identify recipients of bad products before things get out of hand. This built-in accountability protects the manufacturer from failed inspections, delays while waiting for new inventory, and—equally important—a tarnished brand image.
Time Well Spent
The outlook for manufacturers is bright—especially in regards to quality technologies. A centralized quality system like InfinityQS Enact or ProFicient reduces the stress and worry associated with those sometimes-scary audits.
Quality intelligence software eliminates the hassle of juggling paper, makes audits far faster, and enables most organizations to manage audits with just a single individual sitting at a computer.
And your organization will enjoy everyday benefits that help your operations maintain compliance and run smoothly year-round, to the tune of greater insights and accountability, cost savings, and visibility into your supply chain.
Please read more about our Quality Intelligence solutions on our website: Enact
Read other parts of our Manufacturing Challenges