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Pharmaceutical Quality & Collaboration Case Study

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How to finish a $500-million pharma plant on time with high standards of quality: Start with a commitment to Total Quality Management Producing safe pharmaceuticals for a consumer is a highly sensitive process. Pharmaceutical ingredients, including water and air, must meet the utmost standards for purity and cleanliness throughout manufacturing to prevent potentially dangerous contamination.

Background

How to finish a $500-million pharma plant on time with high standards of quality: Start with a commitment to Total Quality Management 

Producing safe pharmaceuticals for consumers is a highly sensitive process. Pharmaceutical ingredients, including water and air, must meet the utmost standards for purity and cleanliness throughout manufacturing to prevent potentially dangerous contamination. Consumer safety starts with a production facility’s construction as the building’s systems are specified, installed, and commissioned. Coordinating quality on a pharmaceutical project is a daunting task, but its success can mean millions of dollars in saving on construction and increased revenue as the building is completed on time.

Challenge:

Quality products start with quality construction

In December 2006, a major U.S. pharmaceutical company pledged to invest $500 million in a new biologics manufacturing facility at one of the company’s European locations. The three-story plant would employ hundreds of workers, manufacturing drugs for the treatment of cancer and other diseases. Part of the construction would be performed off -site by a construction firm specializing in modular construction who would have first responsibility for quality.

Pharmaceutical companies think in terms of systems,” said the company’s manager of qualification. “Purified water, bioreactors, buffer systems.” We need to separate and track issues by systems and be able to demonstrate that all the systems run properly. Then we’re required to commission and qualify all the systems according to FDA guidelines and regulations.” The commissioning and qualification process on any pharmaceutical facility can be long and involved. Any unresolved issues found after the construction phase will still have to be corrected and might force a project to finish or be commissioned behind schedule, costing pharmaceutical company months of production and revenues, potentially totaling millions of dollars.

For this particular project and prospective future projects, the pharmaceutical company needed a computerized quality assurance system that would fit their commitment to TQM and regulate construction quality, so that deficiencies could be more quickly recorded in inspections and resolved by contractors. The system needed to be mobile, so inspectors could use it in the field, and web-based, so that the facility owner and its contractors could access data and reports from their own offices in the United States or anywhere around the world. For complex projects, 15% of project budgets and time can be spent on the last 5% of construction, where bubbles of issues remain unsolved at the time of commissioning (See Figure 1 on next page) and unclear documentation about issues from construction management teams and contractors hinders quick resolutions.

For this project, LATISTA Field allowed construction and quality managers to start quality inspections sooner. With such a comprehensive and efficient quality assurance solution in place, the facility’s owners and builders could identify and correct problems before the commissioning and qualification process started, contributing to the building being completed and certified on schedule.

Solution

LATISTA Field brings it all together

Initially, the pharmaceutical’s construction division lacked a unified system for tracking and reporting issues and deficiencies.  “Inspectors were using their own systems of notecards or notebooks to track issues,” said the director of qualification and commissioning.  The inefficiencies in these paper-based systems pushed the company to test automation solutions, one of which was LATISTA Field.

An automated quality solution like LATISTA Field would allow deficiencies to be entered directly into a central database from a mobile tablet PC without retyping.  Where inspectors were once burdened with drawings, clipboards, books of specifications, digital cameras, and other equipment to document a deficiency, they could now carry a single, lightweight tablet computer that would bring together everything in one portable piece of equipment.

Joe Brown, Shiel Sexton’s Quality Assurance Lead working on the pharmaceutical facility project added, “LATISTA and the tablets make our inspectors more productive because they can conduct more inspections, find more deficiencies, and create reports faster.”  The software automates and coordinates many previously paper-based processes, said Brown, adding that now “Inspectors have everything in one device, one program, and they don’t have to spend time re-entering data or setting up a makeshift desk on a pile of insulation. “LATISTA is an excellent way to keep track of issues, even around the world,” said the director of qualification and commissioning.  “We have people onsite and at the offsite modular construction facility who enter issues and take pictures, and then those are synchronized to LATISTA’s web portal so that others can see what has happened and what is happening” (See Figure 2).  The solution allowed quality-conscious employees at every level to analyze the project looking for possible areas of improvement and to share responsibility for quality.

Even though a contractor produced the facility’s system modules 1,500 miles away, LATISTA could connect all of the construction teams over the Internet to increase collaboration.  Inspectors for the pharmaceutical company and its modular contractors walk through a module multiple times offsite and begin the deficiency correction there.  Then when the module arrives for placement at the jobsite and is inspected before installation, many of the deficiencies have already been found and corrected.  “Inspectors offsite are able to put issues into LATISTA and to track them all the way onto the site where the module is placed,” said Beck.  “They’re really pleased with what they’ve seen and the extension it gives to their own quality processes, and we’re really pleased with how fast issues get corrected before a module is shipped.”

Results

Resolving deficiencies to expedite commissioning and qualification

From an investment standpoint, the pharmaceutical company was able to leave the responsibility and costs of deficiency correction in the hands of their contractors during the construction cycle, when the resources are readily from the contractor and clear responsibility can be determined. Moreover, millions of dollars of additional revenue can be earned from a new manufacturing facility if it opens on time or ahead of schedule versus experiencing costly delays due to unresolved quality issues from the construction phase carrying over to the commissioning and validation phases. “The use of LATISTA tools is a major part of the total quality system we use,” said the director of qualification and commissioning.  “The program helps by greatly reducing or eliminating construction issues during the building process so that we can spend more of our time on performance and making sure our systems will meet specifications.”

LATISTA Field’s dashboard format data analysis and graphing function was another key tool, said Brown:  “We can now collect issues and learn from them.  We’re collecting data on everything—root cause, division, severity, whether an issue could impact commissioning—and we’ll use this in the future to improve quality from the outset.”  Weekly progress meetings were more efficient too since the necessary information was automatically time-stamped and presented in a report.  Supervisors could see current construction status and quickly move on to solving issues in preparation for commissioning and qualifications.

LATISTA is proud to be able to share its technical expertise with this great company and looks forward to being an integral part of the pharmaceutical company’s TQM program.  “LATISTA is uniquely positioned to help leading pharmaceutical companies automate their total quality management practices,” said Chris Ramsey, Executive Vice President of LATISTA. “We provide all the necessary key components including tools for planning quality, daily quality control, commissioning and validation, and contractor web-collaboration tools that form the foundation for automating total quality management.” With the cost savings for customers running into the tens of millions per project, said Ramsey, “LATISTA provides significant return on investment for our customers financially and provides a peace of mind in better controlling variability in project schedules.”

“We’re pleased that a great organization like this one has accepted our web-based, mobile software as an important member of their total quality management efforts,” said Ramsey.  “In addition to the project outlined here, we look forward to working with them on future projects around the world to provide LATISTA’s benefits to all of their projects.”

 

 

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