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An Introduction to NELAC Corrective Actions & Quick Turnaround Samples

 

Complete Article from Edition 47 APG eNewsletter  

Article written by Mike Haller, Operations Manager at APG

What do I do when I receive a Not Acceptable Evaluation?
I have talked to many labs that received a not acceptable evaluation, and their first instinct is to re-run a new sample as quickly as possible to “fix” the issue.  Running another unknown sample is not “fixing” the issue.  The goal is to implement systems to prevent re-occurrence of the issue.  In English, that means don’t make the same mistake twice. 

A not acceptable evaluation should trigger a documented corrective action process traditionally based on ISO standards (ISO 9000 or ISO 17025).  The corrective action process generally follows the framework listed below.

  1. Conduct a root cause analysis
  2. Identify and implement appropriate correct action
  3. Document the investigation and corrective action
  4. Verify that the issue has been resolved

Conducting a Root Cause Analysis
This critical step is the most often overlooked.  First, isolate the issue.  This is often performed by eliminating “known goods”.  If you eliminate what you know to be correct then you can narrow your search for a root cause.  Ask yourself the following questions:

  • Was the data entered correctly? 
  • Were calculations performed correctly? 
  • Were appropriate laboratory procedures available? 
  • Were the procedures followed? 
  • Was the instrumentation properly calibrated?
  • Was the instrumentation properly maintained?
  • Did computer systems operate as expected?
  • Did vendors supply appropriate materials and support?

It is essential to identify the root cause of the issue rather than symptoms.  The majority of root causes are attributed to process / system issues rather than personnel.  For example, identifying personnel issues as the root cause is not normally a good way to eliminate future re-occurrence of the issue.  Personnel and training are normally symptoms of the actual root cause.  I will not discuss this any further because I have found that “Root Cause Analysis for Beginners” (http://www.asq.org/pub/qualityprogress/past/0704/qp0704rooney.pdf) by James J. Rooney and Lee N. Vanden Heuvel is an excellent orientation to effective root cause analysis. 

Identifying Corrective Action – Be Specific, Be Realistic
Effective corrective action is always based on a good root cause analysis, and it comes in many forms.  Some corrective actions are complex, and some are simple.  Some are global organizational changes, and some are isolated to a specific department.  Ask yourself the following questions before implementing a proposed corrective action. 

  • What is the possibility that the issue will re-occur?
  • How likely is the issue to re-occur?
  • How long will it take to implement the corrective action?
  • Is there a simpler solution that would be as effective?
  • Is the cost of implementing the corrective action worth the return on the investment?

Always be specific when identifying corrective actions.  Vague corrective actions are never effective.  Retraining and additional inspection are also not generally effective corrective actions.  In fact, additional inspections may lead to less scrutiny because personnel believe that inspections will find the issues. 

Implementing Corrective Action
Once a strong corrective action has been identified, implementation generally follows the steps listed below.

  • Updates to the laboratory processes and revision of SOPs(procedure)
  • Training on the new or updated SOPs
  • Ongoing monitoring for a period of time to verify that the issue does not re-occur.

Corrective Action Communication
Not acceptable evaluations on proficiency testing samples generally require communication with the laboratory’s accrediting authority within 30 to 60 days.  Once the corrective action process has been documented, accrediting authorities will normally ask the laboratory to analyze another proficiency testing sample to verify that the issue has been resolved.  Remember communication with your accrediting authority and your PT provider are essential.

Corrective Action Verification
Proficiency testing samples for corrective action take one of two forms.  The laboratory can participate in an NELAC compliant PT study operated by an approved PT provider, or the laboratory can purchase a quick turnaround sample.  NELAC compliant PT studies are open for 45 days or less and adhere to the NELAC Standard.  Quick turnaround samples also adhere to the NELAC Standard, but they are processed on a condensed schedule to quickly verify the corrective action.  This is very important for a laboratory that has lost certification or is on probation. 

APG calls our quick turnaround samples Immediate PT STATs.  Immediate PT STAT samples are sent overnight to the laboratory, and the laboratory analyzes them as soon as they have time.  The laboratory then enters the data online and receives immediate feedback.  Within 30 minutes of submitting data online, a copy of the report is sent to the selected accrediting authorities.  The Immediate PT STAT data can also be returned to APG by fax, and APG will send an evaluated report to the laboratory and the selected accrediting authorities within two business days.   

In summary, eliminate crisis management, find the root cause, implement appropriate corrective action to prevent re-occurrence, and communicate with your accrediting authority.  APG understands that resolving these issues is critical to your business, so we are always available to assist you in the process.  Please feel free to send me an email (m.haller@apgqa.com) or give me a call at 800-272-4442 if I can be of additional assistance.


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