MEASURE FOR MEASURE
A Feather in Your QAP
Quality assurance program is essential to process improvement
One of the most important functions in a calibration laboratory is the quality assurance program (QAP), which is crucial in creating a culture where technicians buy into using process improvement to produce a quality product that maintains traceability to national standards.
The philosophy of the QAP should be an improvement based system instead of a compliance based system. Rather than just pointing out what does not comply with directives, one should perform effective root cause analysis (RCA) to improve the process and prevent recurring nonconformities.
To change the culture of the workplace and the mind-set of the workforce, the entire leadership team must be dedicated to the cause. It can be difficult to transform a QAP, especially if the current environment has a “black hat” mentality—where the QAP is seen as the police—but the benefits are well worth the extra effort.
The first step in establishing an improvement based system is to embrace an improvement minded philosophy and the principles that guide the program on a day-to-day basis. Next, management will need to establish a process to sample the equipment for review based on the experience and competency of the workforce. Then, leadership must choose the right people to manage the QAP and perform inspections.
After that, concentrate on conducting effective analysis of nonconformities to reach the true root cause and apply effective corrective action. Finally, analyze the collected data to identify trends and make improvements to processes in the calibration laboratory. To make systematic improvements based on data analysis, however, management must commit to the philosophy of the program.
While compliance with specifications is one way to identify areas for improvement, this is only the first step in an improvement based system. A compliance-oriented system will discover the nonconforming condition and have the technician align the item to bring it within tolerance. An improvement based system does not stop when an item reads out of tolerance during a calibration; instead, it asks why.
An improvement based QAP is also a process focused approach instead of a technician focused approach. The individual technician plays a large—but not the only—part in the calibration process. Ultimately, QAP personnel evaluate the overall laboratory processes for the ability to produce an item that is traceable to national standards.
Some technicians have a hard time adjusting to the process based approach, especially if the previous QAP wore the “black hat.” An emphasis on process improvement in all aspects of the QAP will help ease the transition.
Nothing but the truth
In addition to the process focus, management must establish a consistent and honest environment to help technicians adapt and buy into an improvement based program.
Along those lines, the QAP should make every attempt to deal with similar nonconformities in a straightforward fashion. Failure to do this adds another barrier because the technicians will feel singled out by identifying a nonconformity in one instance but not another.
It is acceptable for the QAP to depart from how it has handled a situation in the past, but it must make all personnel aware of the new standard or practice. This is where honesty becomes crucial.
There should never be a situation where the QAP has a secret because the interpretation will be that the QAP is setting up individuals for failure. The consistent, honest, process focused approach should remain constant throughout; however, there are a few administrative guidelines of the QAP that might vary based on the workforce.
Open or closed?
Day-to-day operations should change based on the workforce. One issue is an open versus closed system for end-of-line sampling. In an open system, the technician can identify the items selected for review. In contrast, a closed system masks this data from the technician.
The open system prevents a bottleneck of equipment in the QAP because it allows for segregation of items selected for inspection. On the other hand, it leaves open the possibility of technicians double-checking the items selected for inspection. A more experienced and trusted workforce can operate very well in an open system, whereas a closed system usually works better for a newer workforce.
Management will also need to decide on the sampling criteria for equipment. This includes the sample rate of equipment and how it is adjusted.
There are two ways to determine the sampling rate—either by examining the laboratory as a whole or each individual member. The individual approach makes it easier for management to quantify poor individual performance but tends to detract from the process focus of the QAP. With an effective and flexible program, it is possible to make a hybrid of the sampling rates.
The laboratory approach can have an overall rate, as well as other adjustable rates based on nonconformity trends. This enables management to target an overall calibration area or even a specific part number.
The purpose of targeting individual areas, technicians or part numbers must only be to collect additional data to verify a theory or monitor the effectiveness of a recent corrective action. Otherwise, the technicians might feel unnecessarily targeted, and it could hamper efforts to have individuals buy into the program.
A consistent, honest and process based approach will go a long way to prevent the individuals from feeling targeted.
Don’t sweat the small stuff
Another factor that will change over time is how much focus is on the big problems versus the little ones.
One of the byproducts of an improvement based system is that as the amount of major nonconformities is reduced, the QAP naturally tries to correct the less significant nonconformities. Approach this carefully, because as the focus on the minor nonconformities increases, technicians can lose the true focus of the calibration laboratory.
For example, the laboratory finds a few problems with the verification of the proper fuse size in the calibration equipment. To correct the problems, management elects to brief and train technicians on what data to use to verify the fuse.
If this is emphasized too strongly, the technician might get too concerned about the minor point of using correct data to look up a fuse size and miss the fact that one of the standards used during the calibration is past the due date.
This is not to say management should ignore the small issues. However, the primary focus of the QAP should be on the bigger ones—the traceability and accuracy of the equipment.
Accomplishing all of these steps will set the foundation for transition to an improvement based system. The next step is to pick the right people to manage the program and perform reviews.
This means selecting personnel who have technical credibility. The technicians must trust that the people reviewing their work are competent to perform the task.
One of the easiest ways to ensure that people are of the highest caliber is to select the top technicians to work as part of the QAP. It is a difficult decision to move a few of the most productive and technically competent people off the bench, but it is the first building block of a solid QAP.
Although they are being moved to different sections, they are still part of the organization and available to train others on the difficult tasks. This has the added benefit of allowing others to fill the void and increase their own knowledge level while maintaining a local safety net.
Management must also consider the temperament of the personnel performing reviews. Process improvement becomes much more difficult in an adversarial environment. Most technicians take great pride in their work, and informing them of a nonconformance can be difficult.
This is why the technicians selected for the QAP must be even-keeled. The moment technicians notice that the reviewer is happy to discover a nonconformity, a lot of credibility and cooperation needed during RCA may be lost.
Accomplishing these steps will put a laboratory on the road to an improvement based system. Two other components of a successful QAP—RCA and trend analysis—will be addressed in a later column.