When your company decides to implement enterprise quality management software, you have to pinpoint which quality processes are prime candidates for automation. You have probably read plenty of information about the undeniably positive correlation between EQMS, nonconformance remediation and subsequent corrective and preventive actions. This blog post takes these benefits a step further and discusses four reasons why to automate audit management could be your first order of business.
1. Automating audit management is a key compliance strategy
With the new version of ISO 9001 released in the fall of 2015, you have started to prepare your company’s quality system to align with updated audit and risk management requirements. You have a limited amount of time to meet these standards before an external compliance auditor literally knocks on your door.
The situation becomes even more worrisome when you include additional compliance mandates in the equation. Medical device manufacturers have dealt with regulatory complexity for decades. Between 2005 and 2012 alone, the Food and Drug Administration increased its quality inspections at life sciences companies by 93 percent, yet CAPA still remains one of the most cited shortcomings of quality subsystems. Automating audit management is low-hanging fruit you can pluck when addressing shortcomings in CAPA.
2. Preparing for the Industrial Internet of Things
A fresh survey by the MPI Group sums up the bottom line about IIoT. Forty-four percent of manufacturers surveyed stated that they lacked deep understanding of how IIoT can improve production, yet 77 percent will increase investment in IIoT over the next two years. If these findings appear spurious to you, you are certainly not alone.
Why would companies invest in technology they do not completely understand? From your perspective as a quality professional, these revelations are a recipe for disaster. Many manufacturers already struggle with disjointed, disparate point solutions that handicap the efficiency of audits. If you deploy EQMS, you will be able to scale up audit management as necessary when emerging technology is tossed into the mix.
3. Combating a culture of poor accountability
You may have to consider automating audit management as a top priority to combat the problem of poor accountability. Manual, paper-driven auditing procedures make it difficult, if not impossible, for your company to keep a single, historical master record of audits. As such, quality issues may go unrecognized, or simply kicked down the road to be addressed at a later date by others with more time on their hands.
When you deploy EQMS, you can quickly change the quality culture in your company since your ability to track and trace issues to specific job roles will be second to none. No one can pass the buck to a supplier or another plant site. Employees will no longer be able to point fingers at one another and overreact when audit outcomes paint an unflattering picture of company-wide performance.
4. Stemming the tide of data overload
It’s likely that you understand the implications of IoT (i.e., the consumer-grade Internet of Things) better than your colleagues, especially when it comes to bringing new products to market. Think of self-driving vehicles as a example. As smart vehicles begin to hit the open road over the next few decades, the vast amount of real-time data will overwhelm companies that are not prepared to feed back this intelligence to manufacturing via automated systems.
At some point, “big data” must simply become actionable data once again. If you automate audit management to accommodate the data deluge that smart products will generate, you will position yourself for success when you have to integrate real-time data at the enterprise level. Otherwise, you may still struggle with silos of data and quality subsystems that make efficient auditing incredibly cumbersome.
Moving forward, you have tough decisions to make during an EQMS deployment. These four reasons outline why automating audit management should be at the top of your list.
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