HPISC Client Impact Stories

Just Get Er Done – Get the Audit Observation Closed Already


We need training for 800 employees, ASAP!

Problem/ Background Situation

In preparation for an imminent post-inspection, a corporate QA mock-up audit was conducted.   The observation item cited a lack of training documentation for Job Aids related to a new process rollout.  

The responsibility to complete the corrective action was assigned to the Quality Unit.  Among the mounting number of findings already assigned to QA, this one was deemed to be a “no brainer” by the VP of Quality.  What’s so hard to figure out?  Missing training records? Just train ‘em!

Requested Performance Objectives

  1. Train 800 employees (technicians) on the Job Aid SOP
  2. Submit the training records as documented evidence to audit team
  3. Get a check mark for closing out the audit findings on time.

HPI Method in Use – (Performance Cause Analysis)

At first glance, the solution appears appropriate.  A traditional training needs analysis begins with the assumption that training is needed and then moves into determining what content to include, followed by classroom delivery.  A performance cause analysis begins with listening to the initial request and then moves into determining what the problem is; followed by the causes.    Beginning with a review of the data related to the request is a critical first step in conducting a performance analysis.   (insert the diagram!)

The Performance Consultant started with the audit observation directly.   A key piece of the finding was lost in translation from the VP of Quality to the Performance Consultant.  The auditors were looking for training records for the actual job aids that were created related to the new process roll out. 

Continuing with the data review, the Performance Consultant also discovered that the employees were already trained on the JOB AID SOP!    Following through with the VP’s request would have been redundant; a huge waste of time and STILL not have addressed the audit observation.  In order to close it out, the Performance Consultant needed to find out two things:

  1. How many job aids were created?
  2. Why weren’t they trained on them?

Primary Cause – Unclear training requirement

The Job Aid SOP only implied that training should occur when a Job Aid is newly created or revised.  Since no formal request was made to train on the individual job aids, no curricula were updated.  Without curricula requirements or a formal training request to trigger training, no training plan was created and no training materials were developed.  As a result, no training was delivered and therefore, no training records were available.

Biggest Challenge – What Wasn’t Happening as Expected

The responsibility for technical training and GMP refreshers lapsed into an abyss when the position was vacated and never back filled.  HR included a cursory review of some basic GMP do’s and don’ts with the little resources they had.  Compliance and technical training became the implied responsibility of the QA unit. 

At the time of the mock inspection, the site was experiencing extreme turnover of key staff positions that threatened the credibility of the quality system owners’ ability to successful interview with external regulators.  The whole site became uber focused on cleaning up documents, closing the loop on hanging paper trails, and preparing for the anticipated post inspection; hence, the mock corporate inspection.  Only priority tasks were assigned and worked on.  “If it isn’t broken, leave it alone” was the coping strategy.  

HPI Solution(s) – End Result

Of the six categories for Human Performance Improvement Solutions, the solution best matched from the causes was to improve the process for new training requirements.

The performance analysis revealed that there were 63 job aids created.  And if all 800 employees were to be trained on these in order to close out the audit, that would result in 50,400 training events to be conducted and documented

Immediate Resolution:

  • Group Job Aids by Process Area and assign to corresponding training matrix
  • Employees assigned to affected training matrices were required to demonstrate competency for only those Job Aids in their training matrix
  • Employees with assigned training matrices for multiple areas had their requirements prioritized according to primary, secondary, tertiary intervals.

Duration to Completion:

Within 1.5 months, primary process area Job Aid training requirements were completed and the audit observation was closed on time.

Near Term Solution – Process Correction:

The Job Aid SOP was revised to require performance demonstration for new and revised Job Aids and to formally request Training Matrix updates via a controlled form to include associated numbered Job Aids when they are created and revised.

Lessons Learned – This is not traditional training

Organizations tend to expect “training” to be training courses that focus on what must be learned and less on what must be done.  When training solutions are used as fixes to address performance needs, it makes training look like a performance activity.  However, the effectiveness of the training “fix” is often not questioned; it’s assumed to work back on the job. 

The HPI approach is strategic because it addresses the effectiveness of the proposed solution and prevention of its reoccurrence similar to CAPA System intention.  In order to sustain the improvement, the solution tends to be a systems-oriented and usually process-driven correction that leads to improved performance for the department and ultimately for the organization.  Therefore, the solution has to remain open-ended until the real root cause is determined. 

Pdf version: business alignment of needs included.

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