July 31, 2013
Lean is a business system focused on continuously improving processes by reducing the time taken and the waste involved in delivering increasing value to the customer. Customers in this case may be internal relative to a system or business process owner/sponsor or external relative to a product or service client.
A computer system validation (CSV) program, like any other subject matter area within a quality management system has business processes it follows that inherently have waste built into them.
Waste: activities that add no value to the product or service but create only time and cost that the customer does not want to pay for.
Value: Value is always defined from the customer’s perspective. It is a benefit that satisfies a need that they are willing to pay for.
So where does one start to evaluate their current situation and focus energy in a positive direction? Perform a quick best practice assessment by asking the following questions:
If you answered no to any of these questions, your approach/process has the opportunity to improve by reducing or eliminating waste so it can become more lean.
Reducing or eliminating waste and becoming more lean means the following:
Do you know the eight types of wastes that affect all processes? Here’s a hint, DOWNTIME.
DOWNTIME is an acronym for the following:
Think of your current processes in terms of these quantifiable waste areas and consider how they can either be reduced or eliminated.
Remember, continuous improvement is just that, continuous. This means the process of reducing effort, time, space, cost, and defects while offering the customer a product or service they actually want is on-going.
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