In my last blog post I talked about the problems facing today’s manufacturers with an ever expanding chain of suppliers and contractors around the globe. Best in class companies are tackling the problem by deploying enterprise wide quality systems. If you simplify the management of quality, what you are doing is tracking and managing things that have happened that are not expected, and what you do about them. In the diagram below, the events that happen are usually discovered by way of audits, manufacturing deviations or non-conformances, laboratory testing, or product complaints. No matter how the problem is discovered, you should follow the same process to remediate it, which is to have affected departments investigate the event, determine the risk to your finished product, determine the root cause of the problem and then take necessary actions to fix the problem and prevent it from recurring. Sometimes this requires a formal CAPA process and Change Control. Once the problem is solved, CAPA’s are closed and changes are accepted, and there should be a process to assure the effectiveness of the actions and changes.
Best in class companies with multiple sites have implemented this process in a single TrackWise Enterprise Quality Management Solution (EQMS), with every site and business unit following the same process. Data fields may differ, based on location and what they make, however the process is the same. Companies using TrackWise have dramatically reduced quality issues globally by applying CAPA’s and change determined by an event at one site, to all sites that may have the same or similar conditions. A top ten pharmaceutical company experienced a 70% reduction in quality events within three years of implementing their TrackWise EQMS.
Dr. W. Edward Deming, the person who revolutionized quality in manufacturing discussed how quality does not come from final inspection, but by doing things right the first time across the manufacturing process. This thinking created the “1-10-100 Rule”. An error caught and fixed immediately costs a factor of 1. An error caught as a result of inspection costs a factor of 10 to correct and an error caught once the product has made it to market costs a factor of 100 or more. Having a single enterprise wide quality system deployed across the manufacturing process dramatically reduces the number of issues found in released product and in final inspection. Not only are these best-in-class companies producing a higher quality product, their quality systems save millions in waste and avoid recalled products.
When a quality event is discovered and entered into TrackWise, it follows a predictable workflow following the process in the above illustration. Required personnel are notified about the issue so they can take actions. Decisions regarding disposition of the component, batch or product are based on investigations and facts collected. The faster a fact based action can be taken; the company will realize significant savings.
Today’s mobile technologies can shave additional days off of the above process. TrackWise Mobile now allows personnel on the shop floor to originate quality events as they are happening which can reduce the investigation by days, and have quality professionals start the investigations while the event is happening. Using the native mobile technology, data regarding the event can be entered into the global system in real time, including photos, and free text fields can be dictated instead of keyed in. Over the years we have analyzed our customer data and have found final sign-offs and approvals of quality issues can take weeks, because executives required for final approvals are not always available on the corporate network. With TrackWise Mobile, traveling executives can be notified of their required approvals, review the record on their smart phone or tablet and apply approvals and electronic signatures without the need to be tethered to their corporate network.
Implementing TrackWise EQMS along with TrackWise Mobile is creating efficiencies never before available in the management of corporate quality. Companies that have implemented these systems are shaving days off of the resolution of quality events. More important than reducing the cycle time is the decisions are fact based, and correct. The result is delivering safe and effective products to market that are trusted by consumers.
There is one last piece to solve, and that is the subject we started with in the first blog. With systems now internally under control, how does a company extend this control out to its vast supply chain? Sparta Systems is excited to introduce Stratas, a game changing product that includes a company’s suppliers and contract manufacturers into their TrackWise EQMS. How Stratas does that will be the subject of the next blog post, stay tuned…
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