Many consider the ’60s through today as an era of analytical and technological revolution. In the ’50s, labs were running manual chemistries, using handwritten QC charts and keeping data in log books and file cabinets. Lab technicians were creating calibration curves by hand. No auto-sampling, no computer control, no electronic interpolation of data. Technicon offered a few automated chemistries in the ’60s. In the ’70s, handheld calculators, ranging from the simple Texas Instruments four-function adding machines to the elaborate Hewlett-Packard scientific calculators, marked the end of slide rules, and Apple introduced its first computer. In 1981, IBM launched its first PC.
Companies such as DuPont, Hewlett- Packard, PerkinElmer and Varian began to introduce computers into their analytical instrumentation systems. Computers helped provide lab data management and automated instrument control.
From the ’60s onward we have seen growth at logarithmetic rates—growth in computer programs, analytical instrumentation, test protocols and the number of analytes to quantitate. Along with this growth has come the need for instrument control and data analysis. Controls, which have ranged from very good to overly cautious, have been self-imposed, auditing-agency imposed and sometimes court-mandated.
Always the need for better control
Though agencies now control standard practice analytical protocols and maintenance requirements, this still hasn’t guaranteed that data produced by two different instruments or in two different labs is in agreement. Sometimes, all the maintenance and proven chemistry in the world will not generate miscible data streams. One example goes back to enzyme analysis in and prior to the ’80s. There were no National Bureau of Standardscertified 99.99% pure enzyme standards. Enzyme results were reported in International (activity) Units rather than concentration units. Different manufacturers built instruments with different reaction-chamber temperatures. The bottom-line result was that enzymes were reported in International Units at 37 °C, at 30 °C or at room temperature. Hospitals would have different normal ranges depending on their method of analysis.
Another example of well-maintained and “in-control” instruments giving differing results occurred in the earlier days of automation. An iron test run on a flow system utilizing membrane filters was the industry standard. Most labs had this instrument. The next generation of instruments used a different technology—an automated spectrometer. This analysis processed whole blood. The result? Some samples run in correlation tests did not agree. Both systems were in control but not always in agreement. The reason was that the new technique was more accurate, which required much of the industry to reprogram its thinking.
Why do we track and apply maintenance?
If you don’t maintain your car, out-of-control actions will become noticeable over time. An untimely breakdown or unexpected repair cost can ruin the family budget. Manufacturers know their equipment best. They determine when various maintenance actions are required in order that the operation consistently generates the highest quality product or data. Well-maintained equipment will help minimize downtime and unbudgeted costs. We document maintenance to help ensure consistent quality.
People perform maintenance. Part of being compliant is maintaining employee training levels and capability records. One “people factor” rarely discussed is “current mentality.” Whether you have two or 200 employees, you can never be absolutely certain what percentage of any one person is on the job right now. Severe storms, a bridge collapse, personal or family illness, service activation and love are some factors that can distract an individual from remembering those proactive maintenance steps required by manufacturers. One of our customers told of an employee who forgot a couple of remote location autosamplers. The auditors found them. Ding. (I highly recommend proactive maintenance software programs whenever possible.)
Maintenance of your chemical inventory is another very important part of laboratory compliance. A lab manager told us that last month her staff had a project with time-sensitive samples come into their lab. They found that two project chemicals had passed their expiration dates. They lost a day securing new chemicals.
Licensing and accrediting agencies were created to perform a needed function. This was (and is) to make sure that labs take the right steps 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 another year’s findings. This normalization of data is the result of the need to ensure that all analyses can be correlated to existing data.
Certification programs can be your business partner
Certification programs can serve you well. Licensure programs can increase the productivity and profitability of your business. Proof of this is often difficult to document. Before working with a quality program, proof might be back-calculated by asking the following questions:
Did audits go smoothly? Were records current, legible, easily found, complete and defensible? Good things happen when an auditor sees that you are prepared. Frequency of audits may be reduced. Audits will move faster. Employees get back to their jobs faster, rather than obsessing about the audit.
Was there scrap product? How much? How much money did losses cost you?
Were losses reduced when working with a quality program?
Reworks? Costs? Frequency of reworks reduced? Reworks cost time, labor and materials. Reworks might delay shipment or data release.
Certification inspections are part of the business of science. Auditors can (and should) routinely ask to see instrument maintenance records and technicians’ documents of capability. The first step in generating reportable data or saleable product is practicing a proactive program to ensure that instruments, equipment and facilities are always maintained to manufacturers’ recommendations.
Some software systems document out of service and unscheduled maintenance.
In the early ’70s, Philip Crosby wrote books titled “Quality Is Free” and “Zero Defects.” His target audience was manufacturing operations. But production is production—whether it’s a car, a soft drink, an aspirin 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; and a higher yield of billable results.
All your assets require maintenance. And your assets include the physical plant, all equipment and instruments, chemicals and reagents, and your employees. The relationship between maintenance and compliance is obvious. Maintaining your lab, equipment, people and chemicals are all audit requirements. Documenting maintenance actions demonstrates compliance.
It is not hard to see a direct link between maintenance, productivity and profitability. Here are two examples of these critical relationships that I have experienced personally:
Some programs allow one to list instruments and link to maintenance manuals.
1. I was managing a customer training function for an instrumentation company. Twice each month we hosted “new customers.” Once each month we gave a class for advanced users. At advanced dinners I would always ask the question: “Is anyone having instrument problems?” The group then took it upon themselves to diagnose the situation as if indeed someone was having problems. Almost every time it turned out that those accounts that had nagging instrument problems were the same accounts that did not accept the serious responsibility of routine maintenance. If you are troubleshooting an instrument problem, you are consuming precious production time and materials. Many times, the down instrument was caused by forgotten maintenance. Lack of maintenance will impact your productivity. Productivity relates directly to profitability.
2. Eighteen months ago, Systea Scientific LLC commissioned my company to make a special maintenance monitoring software program for its EasyChem Discrete Chemistry Analyzer. Two months ago, I was notified that its technical service group was seeing a 50 percent reduction in service calls. Our software tracks maintenance, links to manuals and securely documents actions to help keep users—especially newer users— always on time with all maintenance actions. Users are more productive when following the guidelines. And with the help of the software, users become more proficient. The company also is more productive because it spends less time dealing with customer calls caused by neglected maintenance issues. This has allowed the company to offer extended warranties at no extra cost because of improved efficiency.
Meeting the requirements
Here is an example of documentation required for a typical certifying agency. These selections were taken in 2007 from Chapter 5 of the DOD-updated National Environmental Laboratory Accreditation Program (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.
Documentation requires a fair amount of written records and/or paper-trail notes. Due to the rigid requirements of producing data and reports within time constraints, records may not be updated immediately, fully or legibly, if handwritten. In environmental labs, several analyses are limited by time. Analyses have to be completed within 24 to 48 hours after sample collection. To meet time requirements, these actions might supersede documentation of recently performed maintenance and repair. This can become troublesome later if paperwork has been set aside for the moment and is then forgotten.
This software schedules, tracks and then documents maintenance
First, consistently good product or accurate data produced in a timely fashion is your goal. It is critical that every organization and every employee understand and participate in a proactive maintenance program. (The old DuPont rule was safety first, housekeeping and maintenance second, and production third.) This helps ensure that data reported or product released is of the highest possible quality. Well-maintained instruments consistently generate good data and perform within acceptable limits. The good data can be compared to your own lab and other laboratories.
Second, workloads are increasing. Computers are doing more and more for us in the lab. Lab managers need to stay open and receptive to the new products that are entering this marketplace. You may consider building your own supplemental lab computer programs. These programs will require extensive programming time. Debugging new programs is a monumental task. Program modifications and debugging are never-ending tasks as certifying agencies continue to grow and add to or change existing audit criteria. I believe it is costeffective to find the pre-developed programs that meet your needs.
New software companies are addressing these needs for task tracking and documentation. LIMS do an excellent job tracking samples from when they are drawn through to final report generation. In the past few years, some LIMS programs have added modules to address lab asset management components. Unfortunately, LIMS are fairly complex. And asset management always seems to be the last function programmed with a new LIMS. (And I often find that this job is never completed.)
New software products coming into the marketplace now complete the laboratory compliance circle. Commercial products are being created to perform or guide you through scheduled and unscheduled maintenance actions—and at affordable prices. You must control the validity of your data or product by ensuring that all maintenance is addressed properly. Being compliant helps keep audits moving forward. This in turn helps increase lab (or industry) productivity and profitability.
When agency auditors see handwritten entries that are illegible, incomplete or nonexistent or appear to be written all at the same time, alarms will go off and inspections will go much deeper. They take much longer. This will impact your productivity.
Explore all the emerging opportunities. Take all the steps possible to stay proactive in protecting your lab’s product. The basic fact is that with or without software programs, your lab needs to be compliant and then demonstrate that 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 also plans for future actions.