One of the limitations that is present with the ISO approach to quality control is that, it does not have much weight when it comes to the individual’s performances in a company. Individuals are not required to be responsible for their unique contributions since the company’s effectiveness is viewed as a whole. It can often be quite motivating and more effective for a company to allow individual’s to take responsibility for their contributions. This also helps increase worker’s self-esteem and integrity, which can make them work harder for the company and produce more effective results. Another way in which individual assessment is beneficial is that it encourages interest and concern within the company.
Another limitation of ISO approach is that, it can waste a lot of money. If the goal of the company is to be defect free or only supplying high quality products, and solely that, then there is very little requirement for quality control. It can end up costing the company quite a big chunk of money if any product is rejected and is unusable. It is more effective for a company to have methods of quality control and to fix any errors in a product as they occur, such as thorough fixing or improving.
However, ISO approach often encourages company’s to scrap any defaults altogether. This is fine if all produce is perfect, but it is quite common to have a number of products that are defective. It can also take a lot of time to find the root of the problem, since individual contributions or stages are not as closely monitored, as they would be if ISO paid more attention to the stages as well as the overall effectiveness of a system.
Sometimes ISO only requires a second or third party to help produce the appropriate documentation, which can mean that, the company that is being represented by the ISO approach is actually ineffective and unsafe, besides its documentation representing otherwise. ISO approach relies almost completely on presenting documentation that depict the system’s various procedures, which can be very time consuming and cause a company to lose focus of their business goals in the meantime.
Since those running the company are in charge of arranging the documentation, the time spent gathering this information can take away from the effectiveness of the company during that time.
About the author:
Shruti Bhat PhD MBA Certified Lean Six Sigma Black Belt is Pharmaceutical R&D and Continuous Improvement Director, Innoworks Canada
Shruti leads path-breaking product development programs such as Complex Generics, Nanotechnology and Targeted delivery systems for pharmaceuticals and natural products. Her mantra is to "Shorten development timelines, build quality-by-design, lean processes and bring products fast- to- market". Shruti integrates her proficiency in Design Thinking, Lean, Kaizen and other Continuous Improvement methodologies to improve R&D processes, productivity and profitability.
Shruti is Product Development & Continuous Improvement Advisor to several start ups, mid-size and growing firms in Canada, USA, India, Africa and other Emerging markets. Shruti has authored six books and is an invited speaker at several conferences and workshops.
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