As the Columbia Tech Audit Manager I can say with all assuredness, “lots of them”! We perform process audits and “walk-around” audits, internal quality system audits and supplier audits; we are auditing all the time to be sure that we are “saying what we do and doing what we say”. Understanding the purpose and goal of each type of audit we perform is the key to understanding why we audit as much as we do.
We perform more process audits than any other type of audit here at Columbia Tech. Process audits are just what they sound like – an audit of the processes occurring on the work floor. Regular weekly visits to each work cell, internal and external, to review documentation, equipment, materials and workmanship provide a window into how well our quality systems carry down to the production floor. Audit findings are immediately reviewed with the area supervisor and an audit will not close until any or all issues are addressed to our satisfaction. We audit our quality system at Columbia Tech; not the person. I have never met a single person who woke up in the morning and said, “I’m going to work today to do a bad job”. Therefore, if through an audit we find a problem, it is usually a process, not the associate who is deficient. Our Project Managers, Manufacturing Engineers, Quality Engineers, Calibration, Training and Environment, Health and Safety folks, to name a few, work very hard to help our manufacturing associates build the best products possible in the safest environment.
Supplier Quality audits are performed regularly at our Tier 1 and many of our Tier 2 process material suppliers. The VP of Supply Chain Development and the Audit Manager schedules supplier audits to key suppliers at least once per year. New suppliers, or suppliers who might be having quality issues, may be added to the schedule at any time throughout the year. If any supplier has a corrective action cited in an audit, they will be visited on a frequent basis until no further findings are noted. We prefer to have our suppliers ISO certified, as this evidences a fully documented quality system. But in the end, whether or not the supplier is ISO certified, we audit to verify our suppliers have systems in place to guarantee that Columbia Tech receives quality product today, tomorrow or six months from now in accordance with provided specifications. We look at how they control customer documentation, how “quick turns” and frequent changes are handled and how they provide Columbia Tech with the quality product we require to meet our customers demands.
There are six major categories of internal quality system audits at Columbia Tech: Customer Review, Customer Satisfaction, Production, QMS Review, Procurement and Materials. These audits take place throughout the year and cover every element of the ISO 9001 and 13485 standards – multiple times! Each audit takes approximately one month to complete and focuses closely on the interaction of all the processes of our quality system. When these audits are completed, we know without a doubt how well our systems are performing as a unit.
Last but definitely not least, “walk-around” audits are performed daily. Auditors are always in audit mode when we go to the floor. We check to see if everyone has their ESD straps on, their badge on, if the work cell is neat and orderly, if documentation is present, and if a safe environment is evident. We look to see if tooling is adequate and within calibration date, whether associates are using chemicals properly and within their shelf-life. We check to see that each associate has what they need to do the quality work for which Columbia Tech is known.
Auditing never stops at Columbia Tech. Even on weekends auditors are known to walk the floor to be sure our associates are safe and have all the documents, equipment, materials and help they need to do a quality job. Our goal is to give our customers the product they expect, time after time. Great quality and workmanship are keys to customer satisfaction. Auditing helps us to realize our goal!
Gerry St. Jean
Columbia Tech Audit and Training Manager