Google Analystics

Wednesday, 7 May 2014

What type of Corrective Action can you take when your root cause basically comes down to human error?

This question was asked in an interest group that I belong to on LinkedIn. The questioner asked: How do you go about correcting this, other than discipline or firing?

Now, if you are the manufacturer of a medical device (hardware or software) and a patient or operator is killed or injured because of a "reasonably foreseeable usage error", then the manufacturer of the medical device is held responsible by government regulators for not building into the design of the medical device a means of preventing that usage error. The reasoning is that operator (usage) error (other than wilful and malicious) should be preventable and, as such, treated as an effect, not a cause.

Non-volitional usage errors fall into 3 categories:
SLIPS are, typically, inadvertent finger problems such as accidentally punching a wrong number;
LAPSES are 'missed' actions typically due to forgetfulness or a lapse in attention;
MISTAKES happen when the operator does an action believing it to be the correct one but it produces an undesired outcome.

These point to 3 different types of root cause. Each should be able to be addressed in an appropriate and effective way. What applies to the operation of a medical device (or passenger airliner) can and should also be applied to the operator process in a manufacturing plant, or a Personal Support Worker providing a service in a long-term care home.

Tuesday, 6 May 2014

What is a Quality Management System

A quality management system, or QMS, is a set of documented policies, procedures, processes and responsibilities organized into a structured collection to facilitate a business or organization realizing its quality vision, goals and objectives.

Standards Council of Canada:
"A quality management system (QMS) defines and establishes an organization's quality policy and objectives. It also allows an organization to document and implement the procedures needed to attain these goals."

ASQ (formerly American Society for Quality): "Quality management system (QMS): A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management."