- April 18, 2016
By: Bill Lydon, Editor This article will share some of the key presentation points, and the lively discussion that followed, from the 2015 PAR Benchmarking Survey on Project Management.
Perspectives from the 2015 Pharmaceutical Automation Roundtable
By Bill Lydon, Editor, Automation.com
Pharmaceutical automation leaders from around the world gathered, last fall, for the annual Pharmaceutical Automation Roundtable (PAR) at the Sanofi Pasteur Swiftwater Campus, to discuss a number of automation challenges facing their companies. While the roundtable content was specific to the pharmaceutical and Biotech industries, the challenges discussed are certainly applicable to all industry segments. This article will share some of the key presentation points, and the lively discussion that followed, from the 2015 PAR Benchmarking Survey on Project Management.
Surveyed participants are key players in biotech API (Active Pharmaceutical Ingredients), bulk API, Pharma solids, Pharma aseptic (sterile), and packaging. The survey was completed by 86 participants representing 17 companies.
- 51% Site focused, mostly dedicated to operations at a single location.
- 31% Central resource work with sites globally in a consulting, governance, or project management role.
- 18% Network focused, work across the corporation with sites that have similar processes or technologies.
Major Job Responsibility
- 37% Automation Leader
- 27% Automation Project Manager
- 24% Overall Project Manager Capitalize
- 12% Automation Technologists
Discussion points differ, in many cases, since participants come from companies that have varying automation and operations philosophies.
Project Drivers: What was been the main automation project driver over the past five years?
- 21% On-Time Delivery to Schedule of Automation
- 19% Compliance
- 18% No driver, automation is just another discipline like mechanical and piping that are necessary to build a plant.
- 17% Quality of Automation Delivered
- 11% Cost of Automation
- 10% Serialization
- 4% Other
Participant Discussion Points
- Compliance, in many cases, is a large driver for pharmaceutical projects.
- Automation improves efficiency and accuracy of compliance.
- When the company decides to commercialize new products, out of development, this is a driver to get projects done.
- Since we are trying to use idle production capacity, we are “shoehorning” new products into existing production lines during shutdown time.
- Systems approaching obsolescence is a driver to replace old systems.
- Automation has become accepted as a requirement for projects, compared to a number years ago.
- The cost and schedule of automation is more predictable today than in the past.
- People are starting to see the advantage of investments in automation, which is lowering labor costs and improving quality.
- Manual operations are no longer a viable option since companies are having to meet tight schedules along with shrinking capacities. Having automation is now a necessity.
Maintenance: Is long term automation maintenance and support costs considered in the overall project justification?
- 36% Frequently
- 30% Sometimes
- 27% Always
- 7% Never
Participant Discussion Points
- The capital investment decision makers do not always consider higher initial cost to lower long term lifecycle cost.
- In our company, the basic scope design is production to a target product volume. Additional items are scope adders that we put out on the table and all debate. If a pro-business case can be made, we generally get it approved. The key is to make the options visible.
- In our case there is a discussion with operations, before capital is allocated, determining the best plant automation for production and overall life cycle cost. Those decisions are made up front, so there is less pushback during the project.
Project Structure: How is the average automation project management typically structured? (Editor’s note: client is the project owner in the company.)
- 39% Dedicated Automation Project M manager on Client Side
- 21% Dedicated automation Technical Lead on Client Side
- 16% Client Side Technical Lead and System Integrator Technical Lead
- 11% Engineering Firm and/or System Integrator’ Project Manager
- 11% Dedicated Automation Project manager with PMP Certification on Client Side (Note: PMP, Project Management Professional is an internationally recognized professional designation offered by the Project Management Institute).
- 2% Engineering Firm and/or System Integrator Technical Lead
Based on the survey large projects (>5,000 I/O points) or overall project investment of >$100 million) generally have a dedicated project manager. Smaller projects (< 5,000 I/O points) are more likely to have a technical lead running the project.
Skills desired in an automation project manager include understand production process, know standards, speak so non automation people understand, and can influence the client and stakeholders.
A majority of respondents indicated an automation project manager should have over 10 year’s industry and automation background.
Over 50% of respondents believe an automation project manager should have:
- Instrumentation Background
- Engineering Background
- PMP certification
- IT background
Automation Project Managers with PMP certification and IT background are the hardest to find based on the survey.
The survey indicated project managers including automation leaders and automation project managers generally believe over the last five years projects have achieved good quality.
Participant Discussion Points
- The majority of process changes to requirements are from process engineers and operations.
- Automation scope is typically pretty good. It is the process engineers, who can't write a detailed enough URS (user requirements specifications) and FS (functional specifications),who cause changes. It’s very rare to have something coded wrong. It’s very common to have a process engineer change the way they want to run the process, and this requires automation changes.
- IT is not addressing integration to MES, data analytics, and security.
- The IT part has not been considered. Focus is primarily on PLC and production line. Automation is becoming more and more IT-oriented and the desire for integration has increased.
- Automation is always the last activity in the schedule. Therefore, delays in design/ construction/ installation are expected to be clawed back during automation commissioning/qualification, in order to meet the schedule. This leaves less time for automation.
- The goal of automation is to stay well ahead of the project critical path and deliver the overall project on schedule.
- Automation, in and of itself, is fine. You just need a better promotional effort so people get the message.
- Implementation of automation is typically the last item prior to validation activities. Schedule compression impacts both groups.
- One thing we do is quantify the changes that are process related, beyond the original design.
- We have a mantra in our group, ‘learn first, automate later’. We found ourselves automating things ahead of the process engineers understanding so now we layer in automation in a phased approach opposed to delivering a big bang and getting into this constant change cycle.
Project Execution: - Survey respondents on the top three success factors for project success?
- Over 50% - Sufficient skilled and experienced automation personnel.
- Over 50% - Planning process and well define roles and responsibilities.
- Over 40% - Clarity and timing of user requirements and well-defined scope.
Project Management: Was there an Automation Project Manager on this project?
There is more reliance on internal automation project management people based on the responses to the survey.
- 56% Internal Project Manager
- 25% Both Internal and External
- 16% No Project Manager
- 3% External Contracted Automation Project Manager
The fact that the survey indicated IT background was more important than instrumentation background, for an automation project manager created an interesting discussion. It was apparent that companies differ in the way they handle integration of industrial automation and IT systems.
Participant Discussion Points
It is part of a backlash, because you either learn that technology or you hand part of it off to the IT group.
This is becoming a reality with IT systems, “merging and meshing down” and it is a shift.
It is a reality that people are demanding more vertical integration, and IT integration has become a pain point particularly on big projects.
We are moving more data, and more people are using the results.
We are running DCS on our standard IT infrastructure, except for the controllers and the I/O. Time sync, LDAP (Lightweight Directory Access Protocol), backup, recovery, and other services are provided by IT. There are less automation engineers at the sites, and they are focusing on process optimization.
A lot of our IT is being outsourced, so they want the automation project manager to have the knowledge to work with the IT people.
We are using the IT infrastructure, right down to the controllers, with IT responsible for maintenance support and updates.
New vs. Retrofit
There are number questions related to new and retrofit projects. Of the respondents 68% reported retrofit projects, 24% new facility, 10% have not done a project in the past five years.
New & Retrofit Comparisons
I/O Count - –New facility 5,000 and Retrofit 2,000 points respectively.
Overall project cost - New facility $100,000,000 and Retrofit - $10,000,000
Automation portion of the project cost - New facility - $16,000,000 –Retrofit -$4,000,000
Note: Automation is considered broadly to include: instruments, field devices, wiring, network, process control, and data historian/management system, planning, designing, developing, testing, validating, constructing, and commissioning.
PLC & DCS Application: What was the major process control system on this project?
- 93% DCS
- 3% PLC
- 4% DCS and PLC
- 52% PLC
- 36% DCS
- 12% DSC and PLC
Automation Value Increasing
A comparison was made between PAR Benchmarking 2008 and 2015 surveys, that overall illustrates there is more value being delivered by automation systems for the same amount of money. Top critical success factors include having skilled automation professionals and increased replication, project-to-project. Increased replication included a number of areas including user requirements specifications, test plans, component standardization across work cells, class based structures, specification elements, control modules and programming standards, overall network architecture, graphics and supporting GMP documentation.
About the PAR Meetings and this Article Series
Every year, I have the opportunity to attend the Pharmaceutical Automation Roundtable (PAR) meetings, as the only outside observer. The 2015 PAR meeting was hosted at the Sanofi Pasteur Swiftwater Campus, in Pennsylvania. Lead automation engineers from around the world attended this by invitation-only, two-day event. 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. The PAR meetings represent a very knowledgeable group of automation professionals gathered in one place at one time to discuss automation issues. The participating companies in PAR include: Abbvie, Amgen, Baxalta, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, ImClone Systems, Lilly, Merck, NNE Pharmaplan, Novo Nordisk, Perrigo, Pfizer, and Sanofi Pasteur. The PAR meetings consist of various presentations, given by PAR members, on specific automation related topics. Other members then provide comments about their experience, ideas, and challenges relating to the presented topics. This article series presents a summary of those conversations with each article highlighting one or more of the topics covered by the PAR meetings. Comments by specific PAR members are reported anonymously.
PAR was founded about 17 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company. At the time, the purpose of the PAR 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.
- Bill's Automation Perspective - Industrial Automation Industry Absorbed by IT
- The Journey of IT & OT Integration
- Automation Professionals' Business Role
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