3 Steps to Audit Preparation: Work Toward Less Complexity, Faster Reporting
The pressure of an audit is often compounded by the fear of being unable to produce the necessary documentation to prove compliance.
Several years ago, a large food manufacturer called InfinityQS to attend an executive meeting they were having to address a quality problem with one of their products. Unfortunately, the problem had been discovered at the retail level by one of their big customers. The unhappy customer requested every piece of data for the specified product code for the last 12 months.
The manufacturing organization went into panic mode. A team of seven people was formed to find the data and present them in an understandable format. It took that team two weeks and a lot of energy to get it done.
No company can afford to do that.
Audits are a challenge across manufacturing industries. And as the number of safety regulations grows, quality professionals are spending more time and energy on the daunting task of preparing for an audit while juggling the daily demands of safety guidelines and compliance with regulations and industry standards.
It doesn’t have to be this hard. In today’s connected manufacturing organizations, audits should take a few hours—or even minutes—and shouldn’t be expensive.
The Primary Pain of Audits: Bringing Quality Data 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.
It’s true that you never know what questions the auditor is going to ask or what they might want to see. But the real issue is not the questions; it’s that the answers are scattered in siloed data, distributed across multiple systems. Many manufacturing organizations use a combination of paper, spreadsheets, custom data collection systems, and proprietary software products—and those systems may 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 or even impossible.
Software as a Service Brings Quality Intelligence to All Stakeholders
Without a means of cohesively coordinating quality data, most cobbled-together quality systems do an abysmal job of supporting audit tasks.
Cloud-based Software as a Service (SaaS) quality management software brings it all together. SaaS 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.
There’s no need to invest in additional hardware, and no need to “rip and replace” what you already have on the shop floor or in laboratories. SaaS systems—like the Quality Intelligence solutions we offer at InfinityQS—can gather the data from your existing systems, keep it all in one place, and dramatically streamline your quality reporting needs.
When quality data are collected, standardized, and available in a centralized data repository, full audits go from taking weeks to less than one day. Auditors appreciate the simplicity, speed, and efficiency of computer-based audit reporting. Answers to their questions are just a few clicks away in the software.
Your Audit Plan Should Include Quality Intelligence
Obviously, the ability to produce audit data and reports on demand doesn’t happen by magic. Investing in a comprehensive Quality Intelligence system helps manufacturers support an audit preparation program that can enable you to quickly prove compliance and respond to queries.
Break down your audit preparation into three components:
- Create a plan for compliance
- Prove the plan works
- Control the impact when things go wrong
Create a Plan for Compliance
Maintaining compliance has become more difficult for manufacturers as new safety standards demand they shift from responsive tactics to preventive measures. However, getting those proactive measures in place makes a difference in meeting those requirements.
To facilitate preparedness, your quality software should ensure that:
- Proper checks and tests are accurately recorded and completed on time, every time, every day
- Information is available to the right people at the right time
- Data are standardized across departments and locations
- Production data are available in real time so that operators can immediately correct issues—and quality professionals can ensure processes are performed correctly
Prove the Plan Works
A centralized enterprise Quality Intelligence 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.
Your quality software should allow you to:
- Display summarized data describing full compliance
- Do a deep-dive into a single shift, process, product, or part—all from one computer
- Produce customized reports on demand to provide specific answers for auditor inquiries
Control the Impact When Things Go Wrong
Regardless of the precautions in place, occasionally a defective product may still slip through. 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.
A comprehensive quality solution should:
- Store data in a centralized repository so that they can be accessed quickly
- Enable you to verify the quality of materials and parts coming from suppliers before they enter your process
- Enable fast issue analysis to pinpoint affected products and where they were distributed
- Use lot genealogy to enable accurate tracking so any incorrect products can be quickly located and disposed of before shipment—or in the case of a recall, pulled from shelves
It’s Time to Get Audits Under Control
When you have a plan for compliance, there’s no last-minute scrambling and panic to produce data and documentation. Today’s quality software solutions are purpose-built to enable management of every aspect of manufacturing operations and quality improvement efforts—including audit reporting.
If your organization is still struggling with painful, costly audits, contact InfinityQS to learn how to transform piecemeal data management into a truly accessible, insightful, and useful resource for stakeholders throughout your organization.
Learn more about the transformation that is possible when you have an audit plan in place. Read the free ebook Nothing to Fear: Planning, Executing, and Surviving the Scary and Perilous Task of Audits.