Four risk factors jeopardizing automation projects
Pharmaceutical companies are making a beeline to automate manufacturing. Here are four primary risk factors, most of them non-technical, which might hinder the early phases of any automation project.
Manufacturing automation is the enabler of process improvement and product consistency. Pharmaceutical companies are making a beeline to automate their manufacturing. Regulatory agencies are gearing up to face the challenges of automated manufacturing by actively hiring inspectors who have the requisite skills for auditing such systems.
Many risk factors and challenges exist at the early implementation process. According to Chinmoy Roy, manufacturing operations consultant at Free Lane Consultant, most of these risk factors are non-technical in nature and does not deal with the technical complexities of automation. Roy gave a presentation to pharmaceutical engineers on Monday, Nov. 3 at Pharma Expo in Chicago.
Roy summarized four primary risk factors that might hinder the early process of any automation project.
1. Technology risk factors
Technology risks come from acquiring new equipment, using products under 18 month in market, or using products under development. To eliminate the risk, project managers should ensure the team is properly trained on new technology.
2. Engineering risk factors
Engineering risks come from new system architecture, engineering requirements that are not finalized, companies without a sound business philosophy, or the failure on following industry standards. To overcome these risks, companies should track project performances and avoid operation chock points.
3. Communication risk factors
Communication risks can happen within the management team, with clients, with the design team, and in between project team peers. Such risks can be reduce by running monthly reports, regular signoffs and reviews, and meetings with item data and project information.
4. Planning risk factors
Planning risks come from the project managers’ lack of automation project experience. To overcome the risks, project managers need to constantly track project performances against the project budget. They also need to conduct risk assessments and validation to maintain an effective risk control strategy.
With all the risks come along with a new automation project, Roy said project managers need to focus on validating critical items only, and use quantitative risk management methods to track their automation progress.
– Joy Chang, digital project manager, CFE Media, jchang@cfemedia.com
See additional stories from the 2014 Pack Expo and Pharma Expo below.
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