2015 PAR Insights: Leveraging Supply Chain Solutions with Stage-By-Component | Automation.com

2015 PAR Insights: Leveraging Supply Chain Solutions with Stage-By-Component

September 092016
2015 PAR Insights: Leveraging Supply Chain Solutions with Stage-By-Component

By Bill Lydon, Editor, Automation.com

Driverless vehicles may be in the future for today’s average consumer, but for the pharmaceutical industry, their impact may be right around the corner. This was the message delivered to pharmaceutical leaders from around the world, at last fall's annual Pharmaceutical Automation Roundtable (PAR). The PAR, held at the Sanofi Pasteur Swiftwater Campus, offered discussions regarding a number of automation challenges facing today’s pharmaceutical industry and indeed, which may be applicable to all other industry segments. This article discusses a particular project, presented at the PAR, regarding the improvement of pharmaceutical manufacturing operations, through the deployment of Automated Guided Vehicles (AVG).

According to the presenter, leveraging systems to improve operations was a primary driver of the project. The end goal for facilities, as part of this project, was to achieve Stage By Component (SBC) – the delivery of every component required in the production process, “when I need it and where I need it.”   This was where Automated Guided Vehicles (AVG) served as an enabling technology.   The deployed AVG’s used laser navigation, accurate to a quarter of an inch, enabling the facility to avoid the requirement for in-floor wires.  The presenter further discussed the management of material flow for pharmaceutical production and how the company leveraged system integration opportunities with the collaboration of IT, engineering, and operations groups. This was the company’s first project to integrate from shop floor to the enterprise system and, to achieve this level of integration and enhancement, a lot of common paradigms were changed. 

Production operations were run as push-versus-pull processes that were out of sync with real-time physical activities and the actual transactional activities.  The front end process is all very controlled procedurally, geographically, and utilizes a Warehouse Management System (WMS) and quality control software.   In the past much of the plant processes were manual, paper-based, transactions. The company is migrating away from these manual processes.  Lean is a serious initiative and with improvements they eliminated numerous non-value added “human touches” each requiring multiple manual double checks and associated activities such as adding hand written tags to pallets of material.

The new systems approach resulted in a reduction of excessive material quantities in work centers, which were kept as a buffer for workstations from the effects of inefficient delivery in the past. Further, the new system leveraged the company's ERP system to perform MES functions in real-time.

Project Objectives

The overall project goal was the implementation of a quality, systems-controlled, pull process which would enable more efficient retrieval and delivery of materials to work centers, enhancing production flow.  The solution leveraged automation to minimize repetitive material movements to and from the points of use.  The presenter emphasized this as a flexible approach which would meet changing demand. As he framed the concept: “Press the gas it goes… hit the brakes it stops!”  The project objectives were summarized as follows:

System Driven Quality and Compliance

  • Ensures correct material/batch deliveries
  • Confirms material quality status prior to use
  • Delivers real time materials traceability at point of use
  • Provides end of order reconciliation based actual consumption
  • Maintains systems clearance of foreign materials prior to starting next order

Benefits

  • Leverages ERP to ensure repeatability – RFT Compliance & Quality
  • Annual recurring savings based on process simplification & vehicle automation
  • Six manual touches per material pallet reduced to one automated touch.
  • Increased inventory flexibility by providing a less-than-full pallet quantity delivery option.
  • Savings of over $5 ½ million a year, at over 40 sites

Workplace Organization

Implementing the Lean 5S method of workplace organization -- where the location of everything in the workspace was defined and clearly marked -- was required to ensure the efficient use of AVGs. The AVG was programmed to arrive at the workstation and stop, allowing the operator to take the required materials being delivered. If the workplaces were not organized in an orderly fashion, the work flow could be easily interrupted, as AVG’s make automatic safety stops if something is in its programmed path.  

Note: 5S is the name of a Japanese workplace organization method to organize a work space for efficiency and effectiveness by identifying and storing the items used, maintaining the area and items, and sustaining the new order.

As part of this effort, it was important to educate both operations and warehouse personnel for the use of the new SBC process and AGVs. Familiarizing personnel with the driverless AGV operation in production areas was essential to alleviating any fear of these vehicles.

Now, operators use smartphone-sized wireless handheld computers with a bar code reader connected to the ERP system, and linked to the warehouse management system. The operator simply scans a manufacturing order, their work center ID, and bill of materials for the order and the materials will be delivered to the workstation by the system.

Why Automate Material Handling?

First, process safety is improved by eliminating the threat of people with handcarts. The presenter recalled all the damage done by human-operated forklifts and determined that the AVG’s reduced product and facility damage. Secondly, the material traceability is now automatic, electronically connected to the ERP system, thus improving the productivity, predictability, and consistency of their material handling efforts, all at a reduced cost. 

Why Use Guided Vehicles?

The laser navigation technology of the AVGs helps both avoid the requirement for in floor wires, and enables flexibility by allowing paths to be easily changed and the system to be expanded quickly without infrastructure investments.  As opposed to the installation of fixed material handling tools, this approach does not have a single point of failure that would stop the system. If a single AVG has a problem, it can be quickly replaced with another one.  This also supports GMP (Good Manufacturing Practice) and enables zoning to be changed easily without major investment.

Project Best Practices for Success:

  • Identification of key stakeholders upfront
  • Hold stakeholders accountable for engagement and process sustainability
  • Daily collaboration with and between implementation partners
  • Strong support and input (blueprinting) from:
    • Quality
    • Operations
    • Engineering - IT
    • Daily status reviews core team
    • Weekly status reviews with partners

System Boundaries

Establish system boundaries very early in the project ensures everyone understands their roles.

  • Thoroughly define, agree upon, and document requirements
  • Define what system performs what task
  • Finalize interface definition and design
  • Define who owns each system:
    • IT
    • Engineering
    • Operations
    • Contractor(s)
  • Define who will complete validation of each system

About the PAR Meetings and this Article Series

Every year, I have embraced the opportunity to attend the Pharmaceutical Automation Roundtable (PAR) meetings, as the only outside observer. Lead automation engineers from around the world attended this by invitation-only, two-day event in Pennsylvania. This group of engineers boasts wealth of practical knowledge and knowhow and is always willing to share with other participants – creating a learning environment for all.  Thus, the PAR meetings represent one of the most knowledgeable groups of automation professionals gathered in one place, at any 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, as this one did for AGVs. Comments by specific PAR members are reported anonymously.

About PAR

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.

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