Novo Nordisk developed this facility to produce insulin injecting pens. The magnitude of the validation scope required a strategy to streamline and digitize the administrative processes and documentation.
AMA developed and distributed software (utilizing Excel and Access) designed to merge, organize and categorize published engineering document databases and site quality walkdown punchlisting with various mechanical contractor progress trackers. It was used by site management in issues-tracking, and to best facilitate timely and successful substantial completion efforts. “The project has acted as an ice breaker for further maturing electronic validation in Novo Nordisk … how the interaction with Novo Nordisk Corporate Quality Organizations have benefitted both the DAPI-US project as well as the entire company.” Pharmaceutical Engineering, ISPE, Sept 3, 2019
Aggressive mechanical completion scheduling and compacted trades coordination required a strong emphasis on dedicated, effective punchlisting, conflict identification and issues tracking and resolution between the various on-site contractors.
AMA supplemented DSI’s in-house QC by providing regular, focused system-wide walkdowns and detailed punchlisting. Required a complete understanding of all related code and specification requirements to ensure BPE and contract compliance, well in advance of mechanical completion and systems turnover.
Q/A with AMA
- When first contracted for this project, what did the client express as the main goal / most pressing need for our services to accomplish?
DSI and the general contractor, Fluor, had previously worked together on a successful, large-scale process piping installation at Baxter (later Takeda) in Social Circle, Georgia – during which a number of novel approaches to coordination, project management, and communications were developed to address specific challenges encountered throughout the install. Our client’s main goal was to emulate those approaches and repeat those successful efforts at Novo Nordisk’s DAPI-US project.
- What was the biggest challenge faced during this project and how was AMA able to navigate through any problems faced due to this challenge?
A major feature of the DAPI-US project was a roughly 300-foot long rack of process and utility distribution piping, installed nearly 3 stories above the main production floor. This rack was assembled in a large tent adjacent to the facility — along with all related piping and valving — in three sections. These sections were then ‘flown’ into the facility, mated to the rest of the building structure, and all lengths of piping joined by welds. However, acceptable process piping tolerances and acceptable structural tolerances differ by several orders of magnitude, which made fabricating BPE-compliant welded joints at these transitions extremely challenging.
Our approach was to integrate closely with tradespeople and project management to accurately measure fabricated piping and supports for slope angle and joint alignment in a rigidly systematic fashion – providing all parties with detailed punchlisting and issues-tracking along the way.
- Based off of client feedback, where do you feel we provided the most value to this project?
Our nearly seamless integration with the Novo Nordisk project quality assurance team and Fluor’s project management and engineering teams in providing critical, quality-focused issues-tracking and punchlist coordination contributed greatly to our client’s successful effort at DAPI-US.
- Were there any lessons learned during this project that you believe can be applied to future projects to make them even more successful?
Each and every project provides me with opportunities to develop new knowledge, learn new lessons, and grow professionally. My role at DAPI-US frequently demanded direct involvement in innovative problem-solving and conflict resolution, which will serve to positively inform and influence my efforts on future projects for years to come.
- What was the most rewarding aspect of supporting this project for you?
DAPI-US provided me the distinct pleasure of working shoulder-to-shoulder with what I consider some of the finest professionals in this industry, surrounded by extremely capable and competent individuals – each of whom took great pride in providing Novo Nordisk with a high-quality product in timely manner.