Quality Management oversees all activities and tasks needed to maintain a desired level of excellence to ensure products are fit for intended use (consumer satisfaction). It includes creating and implementing quality planning and assurance as well as quality control and improvement.
Quality Management, among other things, is basically made up of Quality Assurance, QA and Quality Control, QC, with QA having a higher pedigree on the Management scale. Quality Assurance is the process deployed towards the prevention of mistakes or defects in manufactured products, or avoiding problems when delivering solutions or services. ISO 9000 defines QA as part of Quality Management focused on providing confidence that value requirements will be fulfilled. From a layman perspective, QA can be said to be all the steps put in place before a product is produced to ensure the product will meet set specifications or standards. QA can also be termed VALIDATION but not in a strict sense. Validation is a set of procedures carried out on processes to be certain they will deliver as expected of them consistently.
QC, on the other hand, is a procedure or set of procedures intended to ensure that a manufactured product or service adheres to the specifications/standards set before production, and meet consumer/client specifications. Simply put, it’s a set of tests carried out during and/or after production to know the degree of compliance or deviation from set standards. This is what VERIFICATION is.
Going from the above, QA is prospective (planning forward) while QC is retrospective (checking backwards). While QA establishes processes, QC executes these processes. The meeting point of QA and QC is MISTAKES. QA aims to prevent mistakes whereas QC aims to detect/correct these mistakes. Everything we do in Quality Management boils down to anticipation, detection and correction of mistakes. If we have this understanding there is no way we can run away from mistakes or hide them when they occur. Mistakes are a cardinal part of Quality Management. If they are not happening then the Quality management plan needs to be reviewed as nothing is being done.
At the beginning of my career in Quality Management, I worked for a CEO who believed and still believes that one who does not make honest mistakes (there are mistakes borne out of carelessness and negligence) is not doing anything. This principle which was laid down for all staff formed the foundation of my career such that today I am not afraid to try new things or make mistakes. Honest mistakes is the key to inventions as well as a necessity to modifications. Saccharine, which is many times sweeter than sugar was discovered by mistake. Constantine Fahlberg was working on coal tar and its derivatives. On 27 February 1879, after working in his laboratory he forgot to wash his hand. He made an honest mistake. While taking his meal, he observed that everything he touched was extremely sweet. Not knowing what caused this incredible sweetness, he ran back to his laboratory and started tasting all the contents of his beakers. He was lucky he didn’t poison himself but he found the beaker that contained the sweet substance. He went ahead to make a fortune from his honest mistake. As simple as his mistake was (he forgot to wash his hands) it was enough to carve out a place in history for him.
I was not in the laboratory with Mr Fahlberg at the time but I am sure he wrote down all the steps he followed to arrive at the various derivatives of coal tar. If he didn’t do this there is no way he could have replicated the process to arrive at the sweet substance which was named Saccharine. Had he not written down all the steps he followed he would have spent a great deal trying to find out what he did to arrive at the sweet substance. He could not have benefitted from his honest mistake if he was not documenting all the steps he followed. DOCUMENTATION is vital.
If MISTAKE is the pillar that unites QA and QC then DOCUMENTATION is the mortar that binds all together ensuring none falls apart. The critical questions you should ask are
- Are you making enough ‘honest mistakes’?
- What are you learning from these mistakes?
- How are you using these mistakes to inspire other ideas?
- Are you documenting all of them?
The beginning and end of Quality Management is documentation. You cannot argue against this and win. If all the steps in a process are documented properly and afterwards mistakes are spotted, one can easily go back and trace where things actually went wrong without having to speculate. Mistakes which lead to inventions can easily be replicated this way. It is documentation that points out why a mistake was made, when it was made, the effect it had, the corrective measure adopted and its effectiveness. Without proper documentation of all the steps of a process we cannot study mistakes and so we cannot replicate the ones that lead to inventions. In fact, QA/QC has not been complete until documentation is complete. It is as simple as that.
All mistakes in manufacturing/production must be reported and studied, first with the aim to correct and prevent and if carelessness or negligence is established to train/retrain or punish, as the case may be. No matter how we choose to handle mistakes we must not rule out that mistakes create the need for training of the person who made the mistake. Punishment is good sometimes but it should not be the first thing that comes to mind when mistakes occur.
There are mistakes with little or no implications while there are those with huge implications that may even lead to shut down of operations. The mistakes with damning consequences must be tackled through Change Control Process. Change Control is a formal process used to ensure that changes to a process or system are introduced in a controlled and coordinated manner.
As QA/QC people, we must encourage the system to report mistakes as there will be no use hiding them and repeating them because of the fear of being punished. Our job is to prevent mistakes/deviations or correct them when they occur. We must not fail in that duty.
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