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MKH is a Chemist, Validation and Compliance Specialist, cGMP Regulatory Compliance Consultant with world-class expertise in regulatory compliance, training, validation, and quality, production, and new product development management
Speak to this experienced, world-class expert now.
- Call (317) 735-4701
- E-mail mkh@rapid-response-consulting.com
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Following is a summary of a case in which this associate helped a client to dramatically reduce the number of quality errors in their manufacturing plant.
Although the client had the basics of a compliant quality system in place, they were spending too much time and money correcting problems that arose on a daily basis in manufacturing and in the QC laboratory. For instance, the batch sheets typically had 500 blank spaces on them; 500 opportunities for error. Errors were running at a rate of 0.1%, which meant that they were spending considerable time chasing down technicians to collect missing signatures and correct other errors. These kinds of nagging problems were widespread in the organization. Moreover, with that many errors management recognized that it was just a matter of time before one slipped through quality audit resulting in bad product getting to customers. They were a smoldering fire that burned money and everyone's time. Efforts to solve the problems through conventional top-down programs resulted in finger pointing and failure.
This consultant introduced the client to a process that enabled all the employees in the client organization to help improve quality performance. The consultant trained management how to facilitate the program, then trained all the employees how to implement it. This required that management provide the employees with the time to work on their part of the program.
The essence of the process is that management defines the general area of concern and employee teams work to achieve specific objectives that are within their power to achieve. They measure progress toward those objectives and report the results on a periodic basis. Management's job is to enable the process to work. They help the employees by removing barriers to progress and by supplying resources.
The client recognized up front that turning around the culture of a large organization takes time. The results of the program started to become apparent within a year. It took two years before it was clear that the time investment had paid off in terms of performance. The resources required are typically about an hour per week per employee. The consultant's input in the process was restricted to a half dozen seminars with management and employees at the beginning of the project. This involvement was followed up with short teleconferences on an as-needed basis during the year following start-up.
The process generated a grassroots momentum that outstrips any other mechanism for producing behavior change in large groups of people. As the process was implemented the client accumulated measurements that proved the change in behavior. The results for the client were a dramatic reduction in the number of documentation errors and reworked product. Collateral benefits were that the employees learned how to accomplish tasks as a team, working together peer-to-peer. After several months into the implementation the client noticed employees helping each other by suggesting to one another how to improve quality.
Read other articles by this KKAI Associate:
| Chemist, Validation and Compliance Specialist, cGMP Regulatory Compliance Consultant, regulatory compliance, training, validation, and quality, production, and new product development management | |
| Resume of MID | lean manufacturing, expert consultant |
| Resume of OJF | electrical manufacturing, electronics design, expert consultant |
| Resume of CZU | organizational development, human resource expert consultant |
| Resume of KMZ | quality, lean consultant, spc, fmea expert |
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax