Article: Real time SPC & Quality Control at Mölnlycke Health Care supports FDA’s PAT

1. Real time SPC & Quality Control at Mölnlycke Health Care supports FDA’s PAT
(As featured in QMT Magazine March 2010)
Using Infodream SPC Vision software, one of the world's leading providers of single-use
surgical and wound care products and services to the health care sector, Mölnlycke, has
drastically reduced process time, rework, scrap, inspection time and and eradicates the
age-old problem of shopfloor document control
“We can now look forward to increased efficiency, and a huge saving in our time – which,
put simply – is priceless."
Mr Jacques MARIN, Senior, Mölnlycke Health Care, Waremme, Belgium.

2. Company Overview
With 6,200 employees working in nineteen offices across Europe, the Middle-East and
Africa; two offices in North America; and four offices in the Asia Pacific region, Mölnlycke is
truly a global brand. Plant locations include Belgium, the Czech Republic, Finland, France,
Malaysia, Thailand, and the UK, where the Oldham site produces Mölnlycke wound care
products.
Mölnlycke Health Care continuously strives for industry leading reliability and quality in
products and services in the interest of patient safety, customer satisfaction and business
excellence.
Improving Quality & Efficiency
The Mölnlycke plant based in Waremme (Belgium) were keen to adopt the best practice
policies of FDA’s PAT (Process analytical technology). This voluntary best practice framework
promotes the use of innovative development, manufacturing and quality assurance
methods and offers approaches to ensure safety and quality assurance regulatory
requirements are satisfies in addition to driving improvements in productivity and
efficiency.

3. Conventional medical device manufacturing is generally accomplished using batch
processing with testing conducted on collected samples to evaluate quality. PAT methods
are founded on the principle that quality cannot be tested ‘into’ products and must be
‘built in’ through robust manufacturing or preferably by design. The goal of PAT is to
enhance understanding and control the manufacturing process by answering the questions:
 What are the effects of product components on quality?
 What sources of variability are critical?
 How does the process manage variability?
The key step for enhancing process understanding is the collection and analysis of data and
whilst products and process have always been checked, the data is often not analysed
effectively, nor is it immediate, meaning that this approach is of little use for controlling
processes.
Mölnlycke decided to implement a system for collecting shopfloor information in real time,
and quickly realised that their choice of system was crucial, as it would need to satisfy not
only their internal needs but also the stringent requirements of FDA 21, part 11, ISO 2859
and ISO 3951 which are necessary for electronic collection and the retention of production
data.
We are pleased to say that Infodream’s SPC Vision system was selected and has now been
deployed in all areas of the manufacturing facility. Data is collected from a combination of
line-side manual inspections and automated inspection equipment. The user friendly nature
of the software has really been appreciated by the shopfloor as Jacques MARIN explains:
“Simple electronic work instructions now replace the old paper based system. In addition
to removing the paperwork and associated administration, the new SPC Vision method
has the added benefit of eradicating the age-old problem of shop floor document control”.
The information is analysed and immediate reports made, allowing real time quality
assurance and product & process validation. This means that products can be released
faster due to validation at the point of manufacture rather than through final inspection in

4. an offline laboratory. The advanced statistical process control features of the software allow
Mölnlycke to control their processes far more pro-actively, thus managing process variation
to avoid rejects.
“Since implementing SPC Vision we have seen a significant reduction in scrap and re-
processing which has noticeably improved the efficiency of the manufacturing process,”
says Mr. Marin.
With increased process capability and robust process control Mölnlycke can now take full
advantage of the methods promoted by PAT and are able to reduce the quantity of
inspection through a risk based data driven approach described by ISO2859. SPC Vision
provides this functionality with a ‘reception control’ module which actively determines
batch sampling quantity, pass criteria and sampling frequency. This has resulted in a
significant reduction in process time.
To summarise, by embracing the forward thinking approach to quality promoted by FDA
PAT, Mölnlycke have taken a real step forward: “Implementing SPC Vision has helped us to
really understand and manage our processes more effectively, resulting in a real increase
in productivity & efficiency.” Jacques MARIN.
Author: Ben Allister, Infodream Ltd, Published QMT Magazine, March 2010