The ISO certification auditing process can be daunting, especially if the auditor is going to be evaluating your company’s gage management processes based on data housed in your Excel spreadsheets or hand-written documents and note cards stuffed in 3-ring binders.
The real angst comes with hoping the information is current and correct, in the right place and can be easily found (and that nothing has significantly changed since you last updated it).
Because things do frequently change, the gage management process is really a system that lives and breathes. It is a process that gobbles up resources, devours time and must be continuously fed with more information to achieve compliance… compliance that should, ultimately, lead to a future of more efficient manufacturing with far fewer problems. When problems do occur, you must ensure there are procedures in place to find, fix and document the “how, why and when” of those problems and how they were remediated. Most importantly, that certificate of ISO compliance can mean meeting customer requirements which ultimately earns more revenue and increased business from new customers.
When it comes to your gage management system, to achieve this certification, your company must prove through the auditing process that its management policies for all measurement and test equipment are well documented and practiced. To achieve this certification, these processes must track and maintain a gage system over a time and define how the organization operates, even as this systematic documentation process is constantly updated and optimized.
Ease the Anxiety
While the auditing process can be a nerve-wracking event, it doesn’t have to be torturous. If processes are documented and your resulting data is stored properly in a well-designed gage management system, you can achieve compliance. On the morning of the first day of the auditing process, you will want to have a system in place that leaves little in the way of accessing your data, and if necessary, making those last-minute tweaks that can make the difference between a pass or a fail.
Most companies go through at least two of these events, the first being a readiness review, which is an opportunity to make sure the gage management system is organized in the way that the auditors will expect to see it, and understand it, so that both parties are ready to proceed with the actual certification event. The second will be the actual accreditation audit by your chosen registrar. Here you will need to demonstrate your ability to follow and comply with your company’s new SOPs on gage and calibration management; your company will only achieve ISO certification when you (and all other components of your QMS) have demonstrated alignment with those governing standards.
To demonstrate compliance, a capable gage management system is especially critical, considering that there are, potentially, thousands of individual measurement and test equipment in use at any time, spread out across one plant or many. Each gage must be tracked in terms of its usage, the person who used it, and on what part or project it was used. Its calibration history must be tracked and its results analyzed to ensure, among other ISO requirements, that the gage was within accuracy specification limits when it was used.
The auditor will want to know where all the appropriate records are maintained and if they can be readily accessed by quality control and manufacturing personnel. These forms must be controlled and completed properly, and you must demonstrate that the processes in those forms are akin to those in actual practice.
When it comes to measurement and test equipment, the most important information for which the auditors are looking is calibration and usage performance history. In the end, the company’s personnel must know where a gage is at any one time, where it has been, when it’s due for calibration and what its last status was. This is a great deal of information that must be made immediately accessible, all in the moment the auditor requests it.
Gage Management Software Eases the Worry
While it is possible to use paper, note cards or spreadsheets to track your valuable information, dedicated gage management software designed for compliance might be the better solution as compared to that labor-intensive, manual process which at its core has the potential for error and the inability to quickly or easily analyze history in order to predict potential failures. Moreover, using pen and paper or spreadsheets only provides a snapshot of information and it provides little to no historical context. Utilizing commercial gage management software, however, means that all of those hard copy records cluttering your lab can be shuffled off to permanent storage and your important historical information will be stored digitally and more easily backed up for posterity’s sake.
Even the most basic gage management software will streamline your workflow, reduce errors, track gage locations and help in monitoring scheduled and unscheduled calibrations.
On the higher-end packages, you and other team members will be emailed when gages are coming due or for critical events such as out-of-tolerance conditions or failures. You will be able to link blue prints or instructional documents to gages, calibrations and procedure records. You can maintain standards traceability, enforce calibration procedures and even employ advanced statistical analysis tools such as Gage R&R (repeatability and reproducibility) testing for your entire measurement system.
Finally, these software solutions typically employ advanced user security, which ensures the integrity of your data and allows for scalability as the company and its production grows to include more users of the system.
Commercial software applications allow users to quickly recall a gage’s calibration history and mine that data with a couple clicks of a button. This is especially critical for effectively monitoring calibration intervals. These intervals are often based on manufacturer recommendations, but an instrument’s past behavior, its frequency of use, environment and how critical it is to product quality may require you deviate from original recommendations in order to achieve a more stable calibration interval.
While this is certainly possible to track with a paper record, commercial software written for compliance will easily track gage performance and provide more comprehensive calibration data with far less effort.
Just the Facts
The fact is, your company will spend much time and go to a great deal of expense to obtain ISO certification. With that in mind, it is not practical to continue using a gage management system that is dated and vulnerable to failure or misinterpretation of the facts. It only makes sense this day and age, with so many software solutions available, to take the time necessary to ensure your success in an audit. By taking the plunge and implementing effective gage management software, your employees, your customers and your auditors will thank you and your company will thrive. In this, everybody wins.
The Bottom Line
Obtaining ISO certification is the best way to ensure the continued improvement of your Quality Management System and is certain to provide not only an improved company culture and moral, but if successfully implemented, will inevitably increase revenue and add new business. If ISO accreditation will ultimately increase product quality and improve your company’s bottom line, the relatively small amount you will spend to implement and train your employees on an effective gage management software should seem insignificant in light of such incredible gains. If that is not enough, just think how much your anxiety over the customer audit process will be reduced when you finally have real control over you measurement and test equipment.
About The Author
Chris Richardson is the Director of Corporate Sales at CyberMetrics Corporation, developer and worldwide distributor of GAGEtrak calibration management and FaciliWorks CMMS maintenance management software.