In a previous blog post titled, ”Performing an Internal Compliance Audit” I said, “corrective action should focus on process improvement first.” If you want to create a process thinking mindset and “manage by process”, then this blog post is for you.

A lot of manufacturing processes employ batch-records, control-point measures, statistical methods, and other good manufacturing process techniques. Process thinking applies to every business process such as data processing, management, HR, dispatch, delivery, product development, engineering, discipline, promotion, and accounting to name a few.

For me, process starts when I interview potential employees. Yes, I assess their knowledge, skills, and abilities, but I hire them to do two things.

The first is to follow our processes and the second is to continuously adapt and improve the processes to meet the business needs.

If everyone does these two things regularly the results will be effective, efficient, and reliable processes, products, and services.

Whether an issue arises during the workday or is discovered during a compliance audit I want to find the root cause and implement ways to eliminate it from occurring again by asking process based questions. Here is a list of some questions that top management and every employee should be asking. The order can vary due to the situation.

• What process caused the issue?
• The process that caused the issues may not be the same as the process that detected the issues.
• It might be hard to identify the process that caused the issue. Additional checkpoints can be implemented to catch and investigate future occurrences.
• Is the process documented?
• If not, the occurrence of the issue means it's a good time to start a process document. A simple outline of the process with details to prevent the issue in the future is a good start. Workers can fill in more details as needed in the future.
• Is the existing process documentation sufficiently detailed?
• If no, add detail or clarifying notes to address specific situations.
• Was the process document followed?
• If not, why not?
• Did an experienced employee that may not follow the process documentation step-by-step overlook a step?
• Was training insufficient?
• If not, training material or the training process may need to be developed or improved.
• Was there a process change that was not communicated to everyone that needed to know. This would be a failure of the process-change process and it means the process-change process needs to be documented, improved, or followed better.
• Is a checklist need?
• Does the employee need a process refresher?
• Are additional checks need to catch similar issues and occurrences?
• If Yes (the process was followed), then what happened?
• Did something change?
• Has the issue happened before but was not detected?
• Is the issue more complex involving multiple processes or conditions?
• Did bad parts, components, tooling, data input or other elements cause the issue?
• Are creative root cause analysis methods required to find the root cause?
• Is this a process that is performed routinely or occasionally?
• Occasional processes are prone to mistakes and checklist should be followed.
• Does the employee involved perform the process regularly or occasionally?
• Occasional execution of a process needs more detail and should be followed carefully, where someone that performs a process regularly does not.
• What is the probability of this issue recurring
• A high probability means some action should be taken.
• What is the cost, safety, or quality impact if this issue reoccurs?
• A high impact issue means some action should be taken.
• What changes can be made to prevent this issue from recurring?
• Should everyone work from a checklist and initial each step as it is completed?
• Is there a way to automate a prevention measure in firmware or software?
• Is there a way to mechanically prevent the issue from happening?
• Is there a way to tag, flag, mark, or indicate something that will prevent the issue or keep it from going undetected?
• Do improved communication steps need to be added to the process?
• Are there other creative ideas to idiot-proof the process?
• What changes can be made to indicate if this issue occurs again?
• Are corrective actions cost-effective based on the risk associated with the issue?

All of these questions focus on process. This does not mean people issues will not occur but generally, the entire organization starts “thinking process” rather than blaming people. There’s always the person that says “I have a different way to do things and it works for me” or maybe they can not be relied on to manage their time, schedule and priorities. If process thinking is not for them, I have a process to help them find work with someone else.