Management’s View of Automation - Impressions of Automation Performance

Summary

Pharmaceutical Automation Roundtable (PAR) 2012 - Part 1

February 2013

By Bill Lydon, Editor

This is the first article in a series that are the result of the annual Pharmaceutical Automation Roundtable (PAR). I attended the Roundtable in November 2012, hosted by AbbVie, which at the time, was part of Abbott in North Chicago, Illinois. Lead automation engineers from pharmaceutical companies all around the world participated. This group of engineers has a wealth of practical knowledge and knowhow and is willing to share with other participants - truly learning from each other. This is the most knowledgeable group of automation professionals gathered in one place at any one time to discuss automation issues. A range of companies participated including AbbVie, Amgen, Biogen Idec, BMS, Genentech, Genzyme, GSK, Eli Lilly, NNE Pharmaplan, Novo Nordisk, and Pfizer.

About PAR

PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company. At the time, the purpose of the roundtable was to provide a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies.

Survey

Prior to the meeting, PAR members asked colleagues at their companies to complete surveys about Management’s View of Automation. At the meeting, Dave Adler presented the results of this year’s PAR survey. These are my notes on his presentation and comments from participants:

Level of Automation

56% of operations management responded that the level of automation in their facilities was appropriate and 42% that it is too low. A breakdown indicates that many in management have higher expectations of benefits from automation than is being realized in their plants.

Participant Discussion

• One of the biggest barriers to adding automation is the need for plant shutdown.
• One of our big recent projects was switching a historian from one system to another system that did not add any additional functionality.
• Management believes automation can improve performance but maybe they need to be educated on how automation can help them achieve their goals.

Automation Value

Operations management responses indicated they have a good opinion of the value automation provides to their plants - 37% very high value, 33% high value and 30% moderate value. Responses were similar when asked the value provided by automaton staff - 33% very high, 36% high and 29% moderate. Management also believed automation contributed favorably to achieving the goals of improved safety, improved product quality, increased production capacity, and improved regulatory compliance. Vice Presidents and site managers had a lower opinion of automation’s contribution to reduced manufacturing costs.

Participant Discussion

• A lot of cost reduction can be done without automation. Process science changes, for example, can have a big impact compared to automation.
• Pharmaceutical operations have other issues that drive automation harder than cost reduction, including meeting quality and compliance requirements.
• The intensity of computers in automation impacts operating costs since computer deprecation is five years and software is depreciated in 5-10 years. The shorter write-off time lowers the impact of projects in reducing manufacturing costs.
• Many times continuous improvement requires automation that is simply done without considering its positive contribution.
• People that move from old technology to new technology in a major retrofit or upgrade get a big payback. In contrast, process improvements are incremental, that is based on years of learning.

Cost Estimates

Operations management opinions on cost estimates were split. 60% of the respondents answered that capital automation project costs were higher than expected and 40% responded that cost came in as expected.

Participant Discussion

• There was a discussion that it is not uncommon for design problems in piping, valves, and other physical elements to create more costs when automation then need to change to compensate. Automation is the last thing installed so it brings to light many problems and that is when the project contingency budget has been consumed.
• Biotech is just getting into MES and consolidation of automation and MES on these projects is driving costs way up. It is significantly more complicated with a 1,000+ page batch record, and large DCS integration.
• If you replicate an automation project, the cost goes down. I have never seen that on an MES project - the second project costs the same as the first.
• One of the biggest challenges we are having on automation projects is lack of process description, including change orders. The automation people have to estimate a cost without all the data.

Support Costs

Operations management opinions are about evenly spit on support costs meeting expectations. 49% responded that automation support costs were higher than expected, 48% as expected, and 3% lower than expected.

Participant Discussion

• Maybe up front we can estimate project cost and lifecycle maintenance costs for evaluations.
• Investigations of variances that are not automation may be adding to support cost.
• We are making conscious decisions to have lower capital cost even though support will cost more over the lifecycle.
• It might be lower cost to do it up front but they are pushing out capital costs out into future years.

Automation Impressions

Respondents were asked, “What is the first positive trait about automation that comes to mind?”  Respondents were allowed to provide open ended answers and those answers were analyzed and grouped as follows:

Automation People

• Consistency and Control - 26.30%
• Efficiency - 15.80%
• Innovative - 15.80%

Operations and Manufacturing People

• Consistency & control - 30.3%
• Efficiency - 18.2%
• Technically sound - 9.1%

Total Composite Answers

• Consistency & Control - 24.7%
• Efficiency - 13.6%
• Technically sound - 7.4%
• Process Data - 4.9%
• Removal of Human Error - 4.9%
• Innovative - 3.7%
• Compliance - 3.7%

Respondents were asked, “What is the first negative trait about automation that comes to mind?” Respondents were allowed to provide open ended answers and those answers were analyzed and grouped as follows:

Automation People

• Complexity - 21.1%
• Poor communications - 15.8%
• Inflexible - 10.5%

Operations and Manufacturing

• Cost - 24.3%
• Takes too long - 21.2%
• Poor communication - 12.1%
• Understaffed - 6.1%

Total Composite Answers

• Cost - 17.7%
• Takes too long - 12.5%
• Complexity - 12.5%
• Poor communications - 11.3%
• Inflexible - 3.8%
• Understaffed - 3.8%

Other Articles in this PAR Series:

• Part 2 - Managements View of Automation - Investment Value
• Part 3 - Management's View of Automation – Focus of Improvements
• Part 4 - Integrated Manufacturing Systems
• Part 5 - Real Time Data Integration and Dashboarding
• Part 6 - System Obsolescence Planning