In Focus
Non-conformances
It is not about the number
Glynis Bowie
Western Cape Blood Service, Cape Town, South Africa Read bio>
Non-conformances occur every day in our working lives and the impact may be great. Non-conformances can occur as a result of a deviation from operating procedures or policies or from failure to comply with established standards, laws or regulations and can be identified during routine processes, document review and both internal audits and external assessments.
Documenting a non-conformance
The initial process involved in addressing a non-conformance is to identify and document the occurrence. This is followed by an investigation, determination of the root cause of the problem, immediate remedial action, as well as planned corrective action, closure of the non-conformance and monitoring of the effectiveness of the corrective action thereafter. Critical details need to be included when documenting a non-conformance. The problem must be clearly stated and include: • who was involved • what equipment or method was used • where was the event. • when did it occur • which documents/ processes were being followed when the non-conformance was noted • what procedure or standard is referenced
The non-conformance must be clearly stated so that it can be understood by other people. Remember that the person or laboratory investigating the non-conformance may not be the person who identified the non-conformance in the first place or the staff in the laboratory where the non-conformance occurred. There should be sufficient detail to enable a proper investigation so that the risk associated with the non-conformance can be identified and appropriate corrective action can be taken to correct and mitigate any risk identified.
Investigating the non-conformance
There is no ‘one size fits all’ approach when it comes to addressing a non-conformance. Staff can choose different methods, eg. 5 Whys or Fishbone, the explanation of both of which is available on the internet, or even brainstorming with staff. All possibilities and ideas need to be examined to find the correct solution to the problem. However, not all problems need extensive investigation or corrective action when the cause was inadvertent human error. Non-conformances can fit into many categories. It is not about the number of non-conformances raised but rather the type. By monitoring this it may help to focus the corrective action to ensure that it is effective in reducing the type, as well as the number, of non-conformances received.
Example of non-conformance categories identified during 2023 in a South African Blood Service: • Checking - 17% • Issuing -16% • Testing - 15% • Equipment - 15% • Documentation – 12% • Storage and retrieval - 9% • Labelling - 8% • Computer/IT - 8%
While non-conformances must be addressed as soon as possible, their investigation is often delayed by incomplete or ambiguous information that may lead to procrastination before tackling the task. There is a logical sequence to follow; what is the problem; what symptom does it display; what is the cause and what action is required. The cause may be one of many different reasons and each one needs to be investigated and discounted until the true reason(s) is obtained. Staff often document the symptom as the cause, or repeat the problem as it was stated, and do not get to the bottom of the problem. Often staff look at a non-conformance and are happy to implement the quick fix just to get it off their desk and don’t identify the real cause. If the real cause is not identified, the corrective action taken will not address the problem adequately and it will recur. The most common reasons given for the root cause of on-conformances are human error, equipment failure or not following a procedure correctly, but are these the real reasons? Could human error be due to an underlying cause; could it be that the person was undergoing some personal problem which impacted on their ability to concentrate on their work; or could the equipment failure actually be due to inadequate maintenance, or perhaps the procedure was written in a language that was not understood by everyone?
Supporting documents
Before submitting a non-conformance to an assessor or the Quality department to review, the following should be done: • involve the staff concerned in the investigation • evaluate the corrective action to ensure it addresses the original non-conformance • document all steps taken • gather all the supporting documentation to be submitted • record the non-conformance number/ reference on all submitted documentation.
Making the effort to investigate a non-conformance adequately will save time and money in the end and it will result in it being done right the first time. Documenting, investigating and addressing a non-conformance is not a paper exercise to make the Quality department happy, it is a tool which leads to continual improvement, lower risk and safer processes for donors and patients.
