I have enjoyed forty-five years in scientific assignments. We have prepared for audits, helped customers prepare for audits, and now supply software to help others prepare for audits.
Once in my early days as a bench chemist, lab notebooks were collected to serve as evidence in a patent law suit. This experience put “the fear” into me. I learned a lesson in all aspects of documentation and in reporting defensible data.
My scientific career started in 1960. The DuPont Company wanted their scientists to be well-trained, precise, and accurate. We were given special training in weighing on a triple beam balance. Everyone was issued the finest K&E slide rule — scales all over the place. Take the slide out. Reverse it and turn it upside down — so much math — and more fun than the calculators and computers that weren’t heard of yet!
Control and the technological revolution
Let’s consider the 1960s through today as an era of Analytical and Technological Revolution. In the 1950s, hospital labs were running hand chemistries on patient blood. Technicon offered a few automated chemistries in the ‘60s. In the ‘70s, DuPont marketed the Health Care Industries first random access discrete clinical chemistry analyzer. And in the ‘70s, computers began to formulate their roles in lab data management and instrument control.
From the ‘60s forward, we have seen growth at logarithmetic rates — growth in computer programs, in analytical instrumentation, test protocols, and in numbers of analytes to quantitate. Along with this growth came the need for data control. Controls have ranged from very good to overly cautious but we continue to move forward. Control has at times been self imposed and sometimes court mandated.
Licensing and accrediting agencies perform a needed control function. Their service is sometimes perceived in negative connotations but these controls provide the glue to unite, correlate, and validate data streams. When systems are in control, predictive models can be developed, utilized, and built upon. Various labs can run the same project samples and generate correlative data. This year’s studies can be compared to some past year’s findings.
It is important to control the validity of data and help keep audits moving forward. This in turn helps increase lab (or industry) productivity and profitability. In addition, the management of this process should be year round and not only when an audit is just around the corner.
Certification inspections are part of the business of science. Auditors can (and should) routinely ask to see instrument maintenance records. The first step in generating reportable data is in practicing a proactive program to insure instruments are always maintained to the manufacturer’s recommendations. In 1972, Philip Crosby wrote a book, “Quality is Free.” His target audience was manufacturing operations. But production is production — Toyota, Pepsi, aircraft, or data. His premise was that the cost of a quality program more than paid for itself based on fewer reworks or reruns; fewer discarded, lost, or expired samples; fewer exception reports; a higher yield of billable results; and a saving of face. (This one is my own. Don’t you just hate to have to explain “Why” to an auditor or to a customer?)
Here is an example of documentation required for one little segment of National Environmental Laboratory Accreditation Program (NELAP) and other certifying agencies. These selections are taken from Chapter 5 of the DOD updated NELAP version:
- 8.0 b) Equipment and Reference Materials — All equipment shall be properly maintained, inspected, and cleaned. Maintenance procedures shall be documented…
- 9.4.1 Support Equipment — a) …maintained in proper working order…records kept…
- 9.4.1 Support Equipment — e) …documentation on all routine and non-routine maintenance…
- — e) 8) …details of maintenance carried out to date and planned for the future; and…
- — e) 9) …histories of any damage, malfunction, modification or repair…
These types of documentations normally require a fair amount of written records and/or “paper trail” notes. Due to the rigid requirements of producing product (data) within time constraints, records may not be updated immediately, fully nor legibly. In the lab, orthophosphorus or nitrite analysis and BacT platings are examples of “time limited” analyses or procedures. To meet time requirements these actions might supersede documentation of recently performed maintenance and repair. This can later become troublesome if paperwork has been set aside (for the moment) to complete time sensitive analyses.
First, it is critical that every organization and every employee understand and participate in a proactive maintenance program. (I believe the old DuPont rule was safety first, housekeeping and maintenance second, and production third.) This helps insure that data reported to your customers is of the highest quality possible. Controls, curves, blanks, duplicates, and spikes demonstrate that this well-maintained instrument consistently generates “good data.” PTs and unknowns demonstrate your wellmaintained instruments are performing within acceptable limits compared with your own lab and other laboratories.
Second, computers are doing more and more for us in the lab. Lab managers need to stay open to, and receptive to the new products that are starting to enter this marketplace. Some laboratories have allowed themselves the time and salary required to build their own supplemental lab computer programs. These programs fill holes in the hero’s job being done by many LIMS systems. But good programmers cost a lot of money; and debugging new programs is a monumental task. Also, this is probably a never-ending task as certifying agencies continue to grow, to add to, or to change certain existing audit criteria.
New software companies are addressing these holes in task tracking and documentation. Commercial products are being created to perform or guide you through these scheduled and unscheduled actions — and at affordable prices.
One friend, an agency auditor, says that when hand-written entries are illegible, incomplete, non-existent, or appear to be written all at the same time, alarms go off. Inspections go much deeper. They take much longer. If nothing else, this impacts your productivity (and may trigger an acid reflux attack). One of our new customers had lost track of a couple of remote location autosamplers. The auditor found them. Some maintenance actions were overdue.
Explore all of the emerging opportunities. Take all the steps possible to stay proactive in protecting your lab’s product. And, if you can, help send the auditor to lunch early.
The basic fact is — with or without software programs — your lab needs to demonstrate compliance to an auditor. This demonstration includes scheduling, tracking, and documenting instrument and facilities maintenance. This also includes being able to show an ongoing maintenance program that even plans for future actions.