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Eric Gasper


Four Steps to An Audit-Proof Measurement System

Accurate record keeping is key to eliminating audit stress

Published: Thursday, May 5, 2016 - 15:17

An upcoming audit can be one of the more stressful times of the year for a quality team. Whether you are pursuing a new certification or retaining your current one, audit preparation can be a daunting challenge to even the most diligent organization. Although standards such as ISO/IEC 17025, ISO/TS 16949, and AS9100, not to mention FDA standards, differ in many ways as they relate to the measurement system, there are more similarities than differences. Here are a few key steps you can take to ensure your audit process goes smoothly, regardless of the standard.

Step 1: Inventory control

Inventory control is priority No. 1 when it comes to managing your gauges, and it can be broken down into three categories:

1. Locate. Lost gauges are easy targets for auditors. Gauges need to be inventoried and then tracked so that you can easily locate them. A lost gauge represents a risk because if it’s found somewhere other than where it belongs, it could have potentially been used to measure a part on which it wasn’t specified to be used. Lost gauges are also an investment from which you are no longer getting value. Missing IDs are a related audit finding. If the device doesn’t have proper identification displayed, how can you know when the device was last calibrated or when it is next due for calibration?

2. Use. Using overdue gauges may be the most important mistake to avoid and the single most common audit finding, but also beware of the overdue gauges that are not in use. Make sure that gauges awaiting calibration are kept in a controlled environment and not at risk for being used.

3. Maintain. Proper inventory control includes maintaining all gauge records. Records pertaining to all servicing events, including calibrations, verifications, preventive maintenance, and measurement studies must be readily available.

Many industries, including aerospace, automotive, and food and beverage, require retention of gauge records for several years, so a reliable archiving system is critical to meeting this requirement.

Last but certainly not least, when a gauge fails a calibration, you must record what corrective actions were taken.

Step 2: Calibration certificates

When gauges are being calibrated by an outside vendor, it’s critical to check the vendor’s scope of accreditation to make sure that they’re qualified to calibrate your devices. Check to ensure that the calibration certificate you receive from the vendor includes the pertinent details required for your industry. Auditors will likely check that all the required information is included on the certificate and that it is completely accurate. Create a safe, reliable system for storing the certificate so that it can be easily located during an audit. A lost certificate is an easily avoidable finding.

Step 3: Process

Lack of proper employee training can lead to the misuse of gauges. Personnel need to know which device to use for a particular application, and how to properly measure with the device. If the environment is a factor, they need to be educated about the influence that temperature, humidity, dirt, grease, and other external factors can have on the outcome of the measurements. Ensure that you have a proper training program in place and that you keep accurate training records.

Even with the best-trained workers, accidents happen. In the event that a gauge is damaged or dropped, workers need to be educated on the process for removing it from use and verifying or repairing it. They should also be comfortable reporting the incident. W. Edwards Deming’s point No. 8, “Drive out fear,” is relevant here. It is much better to report the incident than to risk measuring with a damaged device.

Step 4: Security

A secure method to prevent tampering is critical. Without it, all the work in steps one through three can be compromised.

For electronic systems, you can create permission levels with password protection, but make sure that the passwords have expiration dates. Develop a reliable system for backing up the data.

For paper environments, a locked cabinet in an area with access limited to relevant personnel is needed. Backups are much more difficult in paper environments, but no less critical.

Commercially supported software systems, such as PQ Systems’ GAGEpack, are designed specifically for gauge management and can eliminate much of the worry. They offer an easy way to organize and manage your measurement system information so that the information auditors are likely to request is available at the push of a button. GAGEpack is designed based on best practices in gauge management, and all four of the steps mentioned above are easily covered.

Remember that the audit process, however daunting, is meant to help you improve. A good internal audit system will help you identify any areas where you have improvement opportunities before the make-or-break audit. Investing the time up front to develop a reliable measurement system will mean less worry when it comes time for the audit.

For more information on this topic, join me and Quality Digest editor in chief Dirk Dusharme in our webinar, also titled, “Four Steps to an Audit-Proof Measurement System,” happening next Thursday, May 12, 3016, at 2 p.m. Eastern, 11 a.m. Pacific. Click here to register.


About The Author

Eric Gasper’s picture

Eric Gasper

Eric Gasper brings a rich background of technical and business analysis, web development, consulting, and team leadership to his role as trainer-consultant for PQ Systems. Experience in laboratory and office environments has given him a unique perspective on a variety of technical problems as well as insight into customers’ unique challenges. Gasper holds a bachelor’s degree in management information systems from the University of Dayton, where he garnered experience with the university’s famed Research Institute prior to entering the work force as a business analyst and development specialist in pharmaceuticals for a major consulting company.