An MD&DI October 1998 Column
Carrie Hartill, senior consultant of Excel Partnership, Inc. (Sandy Hook, CT), discusses some of the considerations for a small manufacturer ramping up for increased production.
What are the most common problems that come up unexpectedly with start-up companies that experience large and sudden increases in production volume?
Consider a large scale-up similar to starting a new business. You should have a business plan and project plan to help manage and monitor progress. These plans will provide directions for how to proceed as the increase continues.
To sustain higher production volumes, facility planning, materials use, and manufacturing flow may need to be reconfigured. Business issues such as cash flow and collection, inventory, supply, and investment outlay should be tightly controlled. External issues should also be considered. For example, traffic may increase because of an increase in the number of employees, shipments, and deliveries. Local zoning and environmental regulations should be reviewed in case they become relevant.
Increasing production volume may mean increasing the number and expertise of employees. This means that there is a potential for greater employee turnover and a need for more sustained, sophisticated training programs. You may also need a temporary pool of employees in order to handle fluctuations in production volume.
In many cases, start-ups consist of highly qualified and educated individuals with a high level of manufacturing expertise. Only limited documentation may have been needed in the past to keep operations running smoothly. If new employees are hired to handle the increased volume, they will probably not be as familiar with the process or the product. Manufacturing documentation may need to be rewritten to bridge this knowledge gap.
You must also consider materials issues. Although qualified for use in small-volume manufacture, materials used with validated processes may need to be requalified when used in greater volumesthey may have more variability in larger quantities. In addition, make certain key materials will be available in the amounts needed to sustain increased manufacturing volumes.
If additional production equipment is needed, it must be qualified if automated, and it may also require validation. If your company acquires new equipment, remember that equipment apparently identical to that currently being used may have been upgraded and may generate different production results when compared with existing equipment. Since all equipment must be maintained to ensure continuing production capability and testing accuracy, review your maintenance schedules and update them to reflect the planned production increase.
The bottom line is that the key to a successful scale-up is thorough documentation. A well-documented system provides confidence in the product and should satisfy regulatory requirements. A framework for such a documented system can be found in 21 CFR 820, more commonly known as the quality system regulation or GMP regulation. Most, if not all, aspects of a production increase can be controlled by applying this type of documented system to all key elements of the manufacturing process.
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