Johnson & Johnson Develops a Risk Assessment Tool
As part of its long-term initiatives, the Quality Systems division of Johnson & Johnson wanted to develop a Risk Assessment Tool that would identify any unwanted business risks and help to decrease the amount of product recalls they faced. This tool would be used with their internal operating companies, including Cordis Corporation, BioSense Webster, Inc., Ethicon, Inc., and others as a method of implementing preventative action towards their ongoing business risks.
Led by the Life Sciences team at Information Mapping, this project required not only gathering an overwhelming amount of information related to Johnson & Johnson's critical business processes, but also determining what information was needed to achieve the business goals of the client.
Challenges
Johnson & Johnson wanted the Risk Assessment Tool to be geared towards the employees actually creating the pharmaceutical products for the operating companies. Information Mapping needed to tap into the minds of these workers to get accurate information about the critical business processes. They would then use the information gathered to create the various modules for the Risk Assessment Tool. The challenge that arose when doing interviews to collect the needed information was that employees were often:
- reluctant to provide information because supervisors were present
- discouraged because they had participated in similar interviews before and no changes or improvements had resulted from them, or
- skeptical about divulging information they viewed as company confidential.
With the aid of effective interviewing skills and techniques, Information Mapping was able to overcome the challenge and collect much useful information to support the various modules that comprised the Risk Assessment Tool.
Solutions
After working with Quality Auditors and running several focus groups to develop the appropriate questions and subcategories of information that would be included in the modules, the tools were tested within the various operating company divisions. In total, nine modules were created in the areas of:
- Change control
- Management operations
- Facility infrastructure
- Materials management
- Verification and testing
- Materials input
- Employee issues
- Employee input, and
- Management, including Process Improvements, Return on Investment and Assessing Business Risks.
Result
This project proved to be extremely beneficial to Johnson & Johnson's operating companies. It helped them determine the risks related to other business processes and develop corrective plans.
In addition, by interviewing workers, Johnson & Johnson was able to increase their workers' motivation and morale, because they felt as though someone was listening to their concerns and valued their opinions.
The next step is to organize and evaluate the abundant amount of information that has been collected, and turn it into a tool that will be useful for increasing productivity and efficiency within the different operating companies at Johnson & Johnson.
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