Cytiva
Who is the operating company (OpCo) for Cytiva?
Danaher
Who is the Site Manufacturing & Operations Leader?
Pierre Arnauld Des Lions
What ISO standard does Cytiva operate under?
ISO9001
What does "QMS" stand for?
Quality Management System
What does "DBS" stand for?
Danaher Business Systems
Name at least three departments at the Shrewsbury Cytiva site.
Quality Assurance, Manufacturing Production, Manufacturing Engineering, Product Engineering, Materials, Warehouse, Sourcing, Supplier Quality, Product Management, Facilities, Custom Engineering, IT
Who is the Site Quality Leader?
Luis Donis
This is the ISO cleanroom classification of the facility where Sefia Expansion Kits are manufactured.
Class 7
What does "EBL" stand for?
Engineering Baseline
This Japanese concept of continuous improvement is described as a way of life in DBS.
Kaizen
What year was the Shrewsbury Cytiva site founded?
2020
Who is the Facilities Manager for Shrewsbury?
Al Grampetro
An inspection record contains all required information, but it was completed several days after the inspection occurred. What data-integrity principle should be questioned?
What is contemporaneous recording?
What does "PPC" stand for?
Production & Process Controls
This tool provides a regular objective method to track performance and identify whether a process is on or off track.
Daily Management
Name all the XDR vessel sizes that are made at Shrewsbury.
10L, 50L, 200L, 500L, 1000L, 2000L
Who is the Environmental Health & Safety (EHS) Leader at the Shrewsbury site?
Mimi Oshinsky
Finding the immediate issue isn't enough. This investigation activity determines the underlying reason the problem occurs.
What does "RMA" stand for?
Return Material Authorization
This DBS tool helps visualize our current process, including its steps, timing and productivity.
Value Stream Mapping (VSM)
What is Cytiva's mission statement?
To advance and accelerate the development of therapeutics
Who is Cytiva CEO?
Chris Riley
An auditor finds that an operator is using a printed work instruction, but a newer revision is currently approved in the electronic system. What is the primary audit concern?
What is document control?
What does "CCN" stand for?
Customer Change Notification
When a problem arises, DBS uses this structured approach to understand why.
Problem Solving Process (PSP)