2017

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Maintaining Knowledge

How ISO 9001:2015 is helping organizations remember their future

by Paul E. Boyers

"Those who cannot remember the past are condemned to repeat it," George Santayana, 1905.1

Many root cause investigations end with the corrective and preventive action (CAPA) of retraining the employee.

But companies are often content to see "retraining" as a repeated response to a root cause analysis (RCA). This repetition should raise several questions:

  • What type of training program is in place?
  • Why was the training ineffective?
  • Did the employee attend the training?
  • Did the employee actually understand the training?
  • Does the organization use a method to determine the trainee’s level of comprehension and competence?
  • Does the organization practice RCA or do they investigate and correct incidents?

Training requires controls

The training process is like the manufacturing process and follows similar steps:

  • Gathering raw material (information).
  • Processing raw material into an acceptable product (training program).
  • Transferring product to the customer (trainee).

Most manufacturing process steps are subject to controls that are monitored and evaluated. But often, organizations allow training programs to operate without controls or standards.

As a process, training is an essential part of the quality management system and should be subject to the same quality controls and standards applied to the manufacturing process. Even though training is an investment in time and resources for most manufacturers, it's often undocumented, uncontrolled and unevaluated.

Internal trainers, while frequently the subject matter experts in their area of responsibility, may have little-to-no training skills. Their skills have been developed through trial and error while mentoring other employees. These trainers often have insufficient guidance from the organization on correctly training new employees for positions. When these trainers move to other positions, organizations often lose their technical proficiency and any training knowledge they've gained from mentoring other employees.

Knowledge management in ISO 9001:2015

Clause 7.1.6 of ISO 9001:2015 tries to address the potential loss of knowledge by helping the organization remember its own past. The standard helps organizations determine the knowledge required for its daily operations and respects that business knowledge is organization-specific.

It acknowledges that the best knowledge to achieve the organization’s objectives is often gained by experience. But the standard goes beyond just a respectful nod by requiring organizations to maintain that knowledge for future use, as necessary. 

The words "to the extent necessary" in clause 7.1.6 are not the loophole implied. Often, an organization uses those or similar words to avoid part of a standard requirement by stating it was determined unnecessary.

When an organization now enters "retraining" as its CAPA for an investigation, that organization admits that the knowledge for training employees is required for daily operations. If that knowledge weren’t required, employees could inherently perform the function, and there wouldn't have been a failure or need to investigate. 

If I was auditing an organization that had entered "training" as a CAPA for an investigation, I would respond:

  • You have determined that training is required to correct and prevent recurrence of this issue. Show me the documented knowledge determined necessary for this operation that has been or will be provided to the employee (to show compliance with clause 7.1.6).
  • Show me how you have or will determine the employee is competent to perform this work (to show compliance with clauses 7.2(a) and 7.2(c)).

Combining clauses 7.1.6 and 7.2 requires an organization remember its past and document those lessons to pass to its future.


Reference

  1. George Santayana, The Life of Reason, 1905.

Paul E. Boyers is the CEO of Quality Consultants and Investigations in Corpus Christi, TX. He has a bachelor’s degree in business management from the University of Phoenix. A member of ASQ, Boyers is an ASQ-certified quality auditor.



Combining clauses 7.1.6 and 7.2 is very good practice.
--Pavel Pavlov, 06-17-2017

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