Situation:
Garfoot Project Services was approached by PCE Automation to project manage, on their behalf, the design, proof-of-concept phase, final build and supply of a fully automated assembly/test machine for a medical device being supplied to one of their key customers.
Challenge:
PCE had taken the order to design and supply a fully automated, bespoke, assembly machine with vision inspection and mechanical quality test to meet strict and detailed URS requirements. The machine was required for a medical device and therefore needed to comply with cGMP guidelines, and meets standards suitable for cleanroom operation and FDA approval. A proof-of-concept phase had to be successfully completed to confirm the proposed technical solutions were feasible.
Additional challenges included:
- Design team members, whilst highly skilled, were relatively new to PCE and based across multiple work sites.
- Complexity of the task was not fully understood, with URS details being revised early in the project, resulting in alterations to resource and time requirements.
- A new design process was being implemented as part of continuous improvement, providing both challenges and opportunities for the designers.
- New and untested technical solutions were required for precision laser cutting, compress heat welding, leak testing and automated vision inspections.
- Compliance with cGMP Validation and FDA approval standards.
- Customer’s quality specification was highly detailed and extremely strict to meet the necessary standards for the end product.
- Customer’s input materials were very susceptible to damage/marking.
- Customer’s input materials were susceptible to static interference making them difficult to handle.
- Assembly process sensitive to ambient light, temperature and dust particles.
Solution:
GPSL were to be responsible for all project management activities from URS response, proof of concept, main machine design, manufacture, assembly, commissioning, validation and final installation through to SAT. GPSL worked with PCE to establish a strong project team with initial focus on design for the proof of concept. GPSL ensured assembly and commissioning teams had an early input into the design where possible to minimise delays later down the line and ensure design considered the human element for build/commissioning.
PRINCE2 / AGILE project management tools were utilised along with PCE’s local processes to ensure resources, risks and budgets were managed whilst meeting the end user’s requirements.
Proof of concept completed on time to meet the requirements for the main order to be placed. Proof of concept identified additional challenges that would be addressed during main design and machine build/testing.
Challenged the design team on material costs to offset the additional resource hours needed on this project with a goal of ensure the overall budget remained within allowable tolerance whilst meeting all requirements. One significant factor was producing a one-piece machine rather than the initially proposed two-part machine. This saved significant time/cost for strip down after FAT and rebuild for install at the customer’s site, as well as providing a much more elegant solution for the customer.
Implemented regular customer meetings for design and project updates, and use of highlight reports, formal design reviews and risk register. This ensured buy-in from the customer and wider project team at all stages with early warning so there were no surprises. This was started at mid-level design phases to enable changes to me made, if necessary, whilst still feasible.
Design took longer than initially planned so to minimise the impact on the overall timeline; the machine parts were released and assembled in a modular manner. This allowed for concurrent design and build.
Results:
Timelines were later than originally planned however supported by the client due to the changes necessary as complexity of the project was identified.
Machine successfully passed FAT and SAT.
Project was delivered within an acceptable cost tolerance. This was aided by management of scope changes and constraints placed on the design team resulting in cost effective solutions to offset increasing demands.
All validation documents were provided to meet cGMP requirements. GPSL were actively involved with writing and reviewing many of these documents.
Project wrap up and lessons learned presented by GPSL was well received by our client.
PM related feedback from PCE’s customer:
“Continuity was important and having a dedicated PM from start to finish”
“Communication between departments/engineers at supplier was strong as the project transitioned from design to assembly to commissioning”
“Design process and design reviews were constructive, and the supplier took onboard our feedback in most cases”
“If I was to emphasise anything it would be the quality of the design reviews that we completed collectively and the attention to detail within those designs. Having been through the designs so thoroughly, when finally seeing the real thing, it was incredibly familiar which helped enormously with becoming more acquainted with the system as a whole”
“There was good dialogue between all team members, which was open and honest”
Feedback from PCE Managing Director – Shaun Wigley*:
“Just wanted to say a big thank you for everything you’ve done during your time with us – you’ve been absolutely brilliant. Your professionalism, attitude, and the way you’ve supported the team hasn’t gone unnoticed, and you’ve made a real impact here.”
“It’s been a genuine pleasure working with you, and you’ll be missed. Wishing you all the very best for what’s next – and hopefully we’ll have the chance to work together again down the line.”
*Written and published with permission from PCE Automation
