Throughout the process of getting your product to market – whether it is solar module certification or FDA approval of a medical device – there are many vendors you must collaborate with and organize to achieve this goal.  This can be a cumbersome process.   It is the goal of Westpak to be the vendor you don’t have to worry about.  Westpak puts ample resources into ensuring our equipment, staff and processes are fully functional, validated and trained so that when you contract us for testing, you have full confidence in our ability to meet your goals.
Let’s assume for the moment that you are conducting a cold chain test requiring thermal mapping of your product and package.  PRIOR to testing, the following action items have already taken place to reduce testing anomalies:

• ENVIRONMENTAL CHAMBER – Prior to being put into service, our chambers are fully validated using an IQ, OQ, PQ process.  This includes a 9-point thermal mapping study, calibration and maintenance.  The calibration and preventative maintenance are repeated on an annual cycle. A quality check (mini cal) is conducted semi-annually to ensure the equipment is reading properly.  On a quarterly basis, chamber performance tests are conducted to test the system’s performance. A back-up system is in place to ensure that even if a chart recorder issue occurs, there is no loss to chamber data.
• CALIBRATION – As Westpak is ISO 17025 accredited, our instrumentation is both NIST traceable and accredited to ensure the highest levels of calibration are met. All instrumentation has an associated Uncertainty of Measurement per ISO 17025.  Furthermore, the RTD or Thermocouple sensors used for testing have undergone annual calibration, semi-annual quality checks AND a pre-test quality check is conducted to ensure the response data is accurate.
• TRAINING – Westpak employees undergo an extensive training program while at Westpak that lasts upwards of a year.  We pride ourselves on hiring degreed engineers whose theory-based training prepares them to assist you in any way possible.  Our training program is ongoing, with monthly ‘lunch and learn’ session to keep our engineers on their toes.
• METHOD VALIDATION – How do you know that you will be getting the same results from Engineer A as you would from Engineer B? The answer is Westpak’s Method Validation program.  The most commonly referenced test methods have undergone an intra-laboratory study modeled after the ASTM round robin studies. Furthermore, Westpak participates in Proficiency Testing, where possible.
• LABORATORY – All areas of our laboratory are cleaned and maintained under daily, weekly and monthly laboratory duties.  These work instructions also include ‘Recovery From Power Outage’ situations.  In our example of cold chain testing, the monthly duties would include a flushing of the chamber boiler as appropriate.
• QUALITY MANAGEMENT – All employees are aware of and adhere to the Quality Management System.  This includes the use of proper internal procedures and following good laboratory and documentation practices. Westpak’s ‘Standards Committee’ regularly reviews industry standards to ensure Westpak is testing to the most current revision of specifications. Westpak’s QMS is regularly scrutinized by UL and A2LA for our ISO 9001 and ISO 17025 registrations.

All of these steps are taken prior to your testing going through our laboratory to reduce the risk of anomalies.  However, we would be imprudent to say that human error doesn’t occur and equipment always performs as programmed.  We work to eliminate these situations as much as possible, but when a testing non-conformance occurs, a thorough risk assessment, root cause analysis and associated corrective actions are thoroughly documented through a Non-conformance Report (NCR).  The customer is always informed in these situations.