Creating a Culture of Compliance

Catch and resolve these common audit issues before the regulators do.

If you’re in the manufacturing industry you understand how essential auditing is to your company’s success. The amount of resources required to report multiple times a year may be frustrating, but their value cannot be overstated.

That said; you hate everything about them.

Here are three tips for getting ahead of your inspection and receiving the most value out of every audit.

1. Risk Avoidance

Audits are all about mitigating risk. Whether it’s risk to your employees, your customers or your bottom line; audits exist to keep your shop on schedule, compliant and safe. Inconsistencies in processes, Operator error and record keeping are among the most common issues reported during internal reviews.

To mitigate these risks you need to both control how work is executed and collect the right data as consistently as possible.

Leverage the digital work packets and data collections in your Manufacturing Execution System (MES) to guarantee every order is built to spec. By utilizing clear work instructions with automatic Quality checks your Operators will have everything they need at their fingertips.

Modern MES platforms also generate permanent as-built records (eDHR) to ensure you have a complete history of every material, tool and process used on an order. With the asset traceability and revision control tools (included in your MES) your data will be reliably stored for easy access when requested by auditors.

2. Know Your Weaknesses

This isn’t your first rodeo. Audit preparation 101 is addressing and reporting on the results of your previous review. You need to show that, not only have past issues been addressed, but that the processes set in place to prevent their reoccurrence have been enforced and well documented. Being docked for a new infraction is bad, but being docked for reoccurring infractions is much worse.

Remember, no two audits/auditors are the same. To assure yourself that processes are being followed, visit the areas most likely to commit an error. This could be anywhere from a highly complex workstation to an area with an above average number of new hires. Regardless, visit your areas where failure is at his highest probability and don’t leave until you’re confident in their success.

3. Stop Cutting Corners

The truth is most manufacturers will only do the bare minimum to pass their audits. Management has other priorities and often sees these check-ins as intrusive and unnecessary. This leads to a culture of sweeping the dirt under the rug twice a year without making any real changes to support the growth of the business.

However, this line of thinking is dangerously flawed. The reality is that there are few greater risks to a manufacturer’s success than losing their certifications. How many customers would your company lose if its ISO 9001, AS 9100 or FDA certifications were revoked?

Implement a long-term solution designed to grow with your business. Do your research and select a vendor with the experience and dedication you need to succeed. Enforce quality, control production and track every order from engineering through delivery with an MES designed for your industry. 

Next Steps

If your company needs a plan leading into your next audit, connect with a CIMx Application Expert today to learn more about complete MES functionality. Our experienced team understands your industry and can provide the insight you need to succeed. Learn more about what the right Manufacturing Execution System can do for your shop today!

Manufacturing Software Experience | CIMx Software

For more than 20 years, CIMx has developed complete solutions for manufacturers. The experience and innovation behind CIMx systems have delivered decades of increased production and cost savings.

Schedule your live Quantum demo with a CIMx Application Expert today!