Keeping Track of Those Old Records

As the universe of quality management systems expands, it’s interesting to observe the increasing variables that constitute the concept of applicability. Let’s take maintenance of records as an example.

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Twenty years ago, the records that were kept and the method of keeping them were relatively straightforward. Most ISO 9001 applications were found in the general manufacturing sector and record maintenance practices were predictably uniform. Records relating to purchasing, customer orders, material receipts, manufacturing processes, and inspections were kept for a specified period of time, which varied from three to seven years, depending on the industry. They were usually hardcopies kept in metal files until they got archived in cardboard boxes warehoused in musty attics.

I’ve recently had the opportunity to encounter some nontraditional applications relating to the control of quality records. It has prompted further reflection on the evolving challenges and constraints that make it essential that we monitor all processes—not just the ones with high visibility such as contract review and process control—to ensure our continued ability to fulfill requirements.

Things change. The media have evolved and applications have spawned new requirements that hadn’t occurred to anyone.

As more municipalities and government agencies adopt quality management system standards, they bring a whole new dimension to the criticality of record retention. During one of my recent trainings, I was introduced to some constraints and challenges that most manufacturing organizations simply don’t have to deal with. Consider what processes have to be developed to achieve adequate control of such things as land deeds, contracts, maps, resolutions, and birth and death records.

The single biggest concern is one of longevity. These records have to be maintained for hundreds of years. What are the challenges they face? The first is preservation. With most manufacturing applications, records are rarely more than two decades old. In a governmental agency, the records are sometimes hundreds of years old. The records, although often mundane in their subject matter, carry vital and irreplaceable information. Land grants are probably the largest category that is still accessed and utilized almost daily. So making sure that records remain “… legible, readily identifiable, and retrievable” isn’t just a nice historical preservation pursuit. It’s essential to ensure that the records, which are still very important today, don’t fade, degrade, or disintegrate. It also means making sure that those accessing the documents have the requisite training in how to handle them.

To further complicate the matter, new records are being created every day. So there have to be multiple methods of storage and preservation. If all the records were fragile historical documents, then there would be one set of processes that would need to be employed. But, there are also records from the early 1900s, the mid-1960s, and 2008. In all instances they have the same mandate for identification, preservation, and access.

But the media also evolved. Records that were once kept in paper form are now consigned to tape drives, floppy disks, microfiche, video, and 8 mm film. Some reside exclusively in electronic media on servers and remote drives. Twenty years ago, the practice of subcontracting maintenance of archives to a third-party records storage facility was still in its infancy.

Government agencies aren’t the only new kids on the QMS block. Consider hospitals and other health care facilities. The need for integrity, accessibility, and protection of medical records will grow exponentially in the next decades as the technology develops and the baby boomers age.

What lessons can the rest of us derive from the challenges these organizations face? First, our records may ultimately need to survive longer than we originally anticipated. Second—and this is perhaps the larger issue—we haven’t been paying enough attention to the evolution in the methods in which we retain records.

A few years back I conducted an audit of a manufacturer who built very large valve assemblies. The units are expected to last for decades—50 to 70 years. When a customer needs a replacement part for a unit that was manufactured more than 25 years ago, the company accesses the original production records using a microfiche reader. What happens when the microfiche reader fails? While there may always be a machine available somewhere, the practical fact is that, as with any aging technology, access will be proportionately diminished.

Look around your own offices and without too much digging you’ll find stacks of 3.5-inch floppies and maybe even a few of the 5.25-inch variety. Most computers don’t even come with an “A” drive anymore. Information storage is careening forward at astonishing speed. What will replace the flash drives that have become so popular in the last few years?

We currently take thousands of paper records and scan them in as PDF files. What will happen if that technology changes? Will your record retention practices be able to keep up?

Maintaining quality records may not be one of the most exciting aspects of your quality system, but you can’t afford to ignore it or else you’ll discover that you can’t retrieve the information when you need it. And in many instances, that failure may very well involve information that your customer needs.

Consider including questions about retention practices and technology as part of your next internal audit. You may be surprised by the answers you get.

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