In another post, I related ISO 9001 documentation to both the Pyramids of Giza and currency. Now, let's turn our attention to what is referred to as “retained documented information,” or more commonly known as “Quality records.”
The international standard for Quality Management, ISO 9001:2015, references the term “retained documented information” no fewer than 24 times. In addition to these required areas, an organization may have extra records which are generated as a result of doing business and, therefore, included in Clause 4.4.2., Quality Management System (QMS) and Processes.
Despite its extensive presence throughout ISO 9001:2015, there’s long been some uncertainty regarding what exactly a documented record is. Many heads have spun trying to make this important distinction, with confusion stemming from a few clichés born out of earlier versions of ISO 9001:
- “Say-what-you-do, Do-what-you-say” – This saying caused people to create a lot of manuals, procedures and instructions that formally “recorded” what was happening in the organization, where no records previously existed. In the past, such a mantra may have been enough to pass a certification audit, but that’s not the purpose of using ISO 9001. Implementing a QMS to comply with the 2015 version requires much more than simply documenting what’s done today.
- “If it isn’t recorded, it didn’t happen” – This is partly true, however it misses the point. Records were required in all previous versions of ISO 9001, but it was only recently that the real purpose of keeping records – other than to pass an audit – was made clear. The generation and retention of records is key to determining the performance of the QMS; it requires an organization to define quality objectives while fulfilling the need for analysis and evaluation of data and information.
Documented information can be simplified as existing in two fundamental categories:
- Planning documentation, or documents created as an intention to do something, and
- Results documentation, or documents created to show that what was intended to happen actually happened
Most of us are familiar with both types of documentation. When we buy or lease a car, there’s often a sizeable package of documents that describe, in one form or another, information regarding the effective operation/ownership of that car. Included in this documentation is a schedule detailing the extent and frequency of the required preventive maintenance to support the driving experience. On each visit to the dealership, a comprehensive note with key data regarding the service(s) provided is taken by the dealer’s service writer, including:
- Customer information (address, phone number, signature, etc.)
- Car information (VIN #, make/model, mileage)
- Service to be performed (oil and filter change, tire rotation, etc.)
Upon completion, the service writer produces a copy of the original detailed notes, adding the details of what was done by the service technician, including:
- Technician information (name and license #)
- Work performed (oil grade and quantity, filter type)
- Measurements made (tire tread depth, brake pad thickness, tire pressures)
- Additional information (recommendations for additional work needed, campaign/warranty work needed, next service mileage)
These service records – normally maintained by the dealer on their computer network – provide useful information for the owner, dealership(s) and even future purchasers (in the event the vehicle is sold later) to effectively build confidence that the requirements have been satisfied. As an example, it’s rare to find a pre-owned car or truck for sale without a “CarFax” report – a detailed record of the life history of the vehicle.
Using Records to Improve the Business
Philosopher and writer George Santayana is credited with saying, “Those who do not learn history are doomed to repeat it.” Records contain invaluable information about the historical performance of the QMS. If an organization takes the time to evaluate this data, past mistakes can be avoided and cost benefits realized. After all, you wouldn’t take your car in for an oil change before it’s due!
For example, say an organization buys top-of-the-line torque wrenches and has them calibrated at an ISO/IEC 17025 accredited calibration laboratory every year at a cost of $110 each, which includes the usual data from the calibration activities. A review of the “as found” condition from more than five years’ worth of data shows there had been no real change in performance and no adjustments were necessary. Essentially, the records showed that the costly calibration was not needed every year. This could have added up to hundreds of savings on just one wrench alone.
Similarly, when one larger manufacturer analyzed the reasons for product rejections, they uncovered an estimated $8M savings in administrative costs alone, which were associated with processing non-conforming products. These savings likely never would have been identified without having detailed records in place.
Rather than simply maintaining documents just to pass an audit, consider dragging out those old records to get a look at the company’s past to find new opportunities for growth and stop repeating history, like a record spinning ‘round and ‘round…
“You spin me right round, baby
Right round like a record, baby
Right round round round
You spin me right round, baby
Right round like a record, baby
Right round round round”
-“You Spin Me Round (Like a Record)” by Dead or Alive
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