ROOT CAUSE HUMAN ERROR ASQ SECTION 501 Mark

ROOT CAUSE- HUMAN ERROR ASQ SECTION 501 Mark Loewen 13 February 2018

Definition- Human Error Human error means that something has been done that was "not intended by the actor; not desired by a set of rules or an external observer; or that led the task or system outside its acceptable limits".

Definition- Human Error For our purposes today… A human error is a failure of a person to directly interact with a process in a way that results in a real or potential nonconformiuty.

Definition- Root cause The root cause is an initiating cause of either a condition or a causal chain that leads to an outcome or effect of interest. The term denotes the earliest, most basic, 'deepest', cause for a given behavior; most often a fault.

Human Error as Root Cause How many of you have ever seen a proposed root cause listed as “human error”? If so, what is the most frequent proposed corrective action to take to address human error?

RE-TRAINING

Human Error as Root Cause What has been your experience with the effectiveness of re-training preventing recurrence of an issue over the long term?

Human Error as Immediate Cause But…since humans are involved in a large number of processes, it is reasonable to expect human error as the immediate cause of many faults. If we want involvement from others in determining true root causes that derive from human action, we need to consider providing tools that will help them to do so.

Human Error? 1. A blending process requires addition of a solvent as the second step. Solvent addition by the operator occurred later when it was discovered that the step had been missed. This resulted in an inadequate chemical reaction. Human Error?

Human Error? 2. Due to a bug, software used in maintaining product master data (part numbers, pricing, BOMs, etc. ) would omit the last three lines of a particular query when a certain keystroke chain was entered. Human Error?

Human Error? 3. An on-line visual detection system was used to shut down the line if a component was missing and the beam was not interrupted. The system failed intermittently causing products with missing components to pass on to packaging. Human Error?

Human Error as a Root Cause. The first step Any time there is human involvement in a process, the first step in determining the root cause(s) is to… INTERVIEW THOSE INVOLVED!!!!!

Human Error as a Root Cause. The first step Any time there is human involvement in a process, the first step in determining the root cause(s) is to… INTERVIEW THOSE INVOLVED!!!!! – Promote transparency – Make the interview safe and objective – Map the process as described – Ask the classic…who, what, when, where & how (don’t ask “why” yet)

Human Error. Categories The next step is to categorize the human error into one or more of five categories. These are the descriptions of WHAT happened. A. Action not done B. Action not done properly C. Action not done completely D. Wrong action done E. Wrong decision made

Human Error. Root Cause Sub-Categories Once the category of human error has been determined, the root cause(s) categories need to be defined. These are the descriptions of WHY the issue happened. You can use methods such as 5 -Why or Ishikawa analysis, especially to determine details, but try to assign one of the following sub-categories to each final cause.

Human Error. Root Cause Sub-Categories • Procedure- does not properly describe the process • Communication or information- other information not related to the procedure • Training- not done or inadequate; be sure it is specifically a training issue • Recent change

Human Error. Root Cause Sub-Categories • • • Non-standard issue Time Resources Housekeeping Complexity of the task Interruption or Distraction

Human Error. Actions Once the “Why” has been determined, actions typically relate to one of the following areas: • Organizational actions- how the structure operates • Procedural- steps defining a process • Mechanical- hardware, tools, software, etc. • Process- controls or methods • Design • Human Factors Engineering- interactions with tools and machines

Human Error Case Studies Issue: Unable to verify that PM's are being performed in accordance with the schedule. For example… • Monthly PM's were not performed on the Adhesive equipment between May and September 2015, • Several PM records for the XXXX were not completed as scheduled: 4/30/15 completed on 6/16/15, • XXXX scheduled 8/4/14, completed 10/13/14, scheduled 9/2/14, no completion date entered. Response: Human error- schedule overlooked. Will retrain Techs on importance of following schedules.

Human Error Case Studies Issue: In the compounding room a drum of glycerin was being transferred into the mixing tank. There was a spray bottle of 70% IPA setting on the top of the drum near the open pump port for the transfer process which is a potential for the raw material and product contamination. Response: Compounder forgot to pick up the spray bottle. Retrain him.

Human Error Case Studies Issue: Warehouse dock doors are not sealed and two man doors (one in raw material receiving and one adjacent to the washroom) do not completely close to protect from intrusion of insects and rodents. Response: The damage to doors indicated in the audit nonconformance had not been addressed by Plant Facility Maintenance personnel because of inattention to their responsibilities for facility inspection and correction of problems noted. NOTE- This was one of four audit nonconformances, all reported by a VP as being due to “inattention to responsibilities”.

COMMENTS? ? ? QUESTIONS? ? ?