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Defining Quality


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Solving the Quality Problems

It is not difficult to develop plans that can curb the wasted time and money spent on internal quality issues. One of the biggest problems a growing company can experience today is the inability to monitor and enforce the standards that have been created to eliminate quality issues. Companies see this as an added expense instead of a cost savings program. Many of the top rated companies and many regulatory agencies have developed ratios of supervision to manufacturing employees and ratios of quality assurance personnel to manufacturing employees. Generally, the ratios are one supervisor to every five to 10 employees and one quality assurance person to every 15 employees. Certainly, proper staffing is more costly than improper staffing, but the benefits, basically, pay for themselves and then some. Most companies are not far off this mark, and by simply adding a few qualified people in the right positions, the time and efforts spent correcting internal quality issues can be greatly reduced.

Once the right people are in the right positions, the biggest concern becomes training those who handle the processing of the products. After all, these are the people responsible for quality. It is important that a company let its employees know who is responsible for quality. A misconception by many is that the quality control (QC) or quality assurance (QA) department is responsible for the quality of the product. The QC units can only “check” the quality of the products; manufacturing is truly responsible for creating a quality product.

Training is not wasted time, as some companies may believe. Training is an investment in employees. If a company buys a new tablet press for $350,000, that tablet press will have the same output of tablets it was designed to produce today, tomorrow and into the future. However, an employee, if properly trained, will increase his output potential in accordance with the amount and the quality of the training he receives. This increases the value of the employee over time. To not train employees promotes complacency and a lack of initiative. Employees like the idea of “climbing the ladder” of responsibility, which can lead to higher wages and promotions.

Training programs must set goals for the employees. A company can validate its training programs through testing. Training and testing can be split into levels with time and other prerequisites between such levels. Employees can be motivated to pursue the next level by creating a wage scale connected to the various levels of training and testing. Most employees respond to this type of program very well. Those who do not respond reveal themselves as the wrong match for that particular job. Thus, this type of program, if instituted correctly, allows a company to document the successes of one employee and the failures of another. Actions can be taken with more decisive measures that will benefit the company and the quality of the products, while creating better profitability.

Plan of Action

Many companies provide high-quality products to their customers. These same companies still experience internal quality issues that cost the company time and effort, and affect the bottom line. Any reduction in the cost of rework or machine down-time, labor costs, or any increase in production yields generates a return of “pure” profit. Many companies don’t realize the lost revenues due to the lack of any formal investigations into these events.

The path to eliminating all quality issues is never ending. However, to not start a program to identify and attack these issues is proven to be a very costly mistake. Yet, creating these programs is not difficult and the benefits far outweigh the outcome if a company ignores these issues. A plan can be developed by following these simple steps:

Evaluate the ratios of supervision and quality assurance personnel to the number of employees involved in manufacturing.

Create an investigation program to target quality issues at the time they occur, and make all employees aware that all quality issues, including low yields, will be investigated. The outcome of any investigation should lead to a permanent correction to prevent the same quality issues from recurring.

Develop a training program that is both progressive and provides incentives for employees.

Once a good quality program is established, recurring quality issues will continue to decline. Profitability will increase, and the money saved by such a program will more than cover the costs of maintaining the program.

Gary Callahan is president and CEO of Pharmaceutical Consulting Services, which helps companies to implement GMP(good manufacturing practice) and other quality programs. He has more than 35 years of hands-on and management experience in the pharmaceutical manufacturing industry. He has implemented many GMP and SOP (standard operating procedures) programs in several different companies to meet compliance standards set by the FDA.

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