Article: Real time SPC & Quality Control at Mölnlycke Health Care supports FDA’s PAT
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 worlds leading providers of single-usesurgical and wound care products and services to the health care sector, Mölnlycke, hasdrastically reduced process time, rework, scrap, inspection time and and eradicates theage-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.
Company OverviewWith 6,200 employees working in nineteen offices across Europe, the Middle-East andAfrica; two offices in North America; and four offices in the Asia Pacific region, Mölnlycke istruly a global brand. Plant locations include Belgium, the Czech Republic, Finland, France,Malaysia, Thailand, and the UK, where the Oldham site produces Mölnlycke wound careproducts.Mölnlycke Health Care continuously strives for industry leading reliability and quality inproducts and services in the interest of patient safety, customer satisfaction and businessexcellence.Improving Quality & EfficiencyThe Mölnlycke plant based in Waremme (Belgium) were keen to adopt the best practicepolicies of FDA’s PAT (Process analytical technology). This voluntary best practice frameworkpromotes the use of innovative development, manufacturing and quality assurancemethods and offers approaches to ensure safety and quality assurance regulatoryrequirements are satisfies in addition to driving improvements in productivity andefficiency.
Conventional medical device manufacturing is generally accomplished using batchprocessing with testing conducted on collected samples to evaluate quality. PAT methodsare 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 toenhance 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 andwhilst products and process have always been checked, the data is often not analysedeffectively, nor is it immediate, meaning that this approach is of little use for controllingprocesses.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 notonly their internal needs but also the stringent requirements of FDA 21, part 11, ISO 2859and ISO 3951 which are necessary for electronic collection and the retention of productiondata.We are pleased to say that Infodream’s SPC Vision system was selected and has now beendeployed in all areas of the manufacturing facility. Data is collected from a combination ofline-side manual inspections and automated inspection equipment. The user friendly natureof 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 additionto removing the paperwork and associated administration, the new SPC Vision methodhas 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 qualityassurance and product & process validation. This means that products can be releasedfaster due to validation at the point of manufacture rather than through final inspection in
an offline laboratory. The advanced statistical process control features of the software allowMölnlycke to control their processes far more pro-actively, thus managing process variationto 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 fulladvantage of the methods promoted by PAT and are able to reduce the quantity ofinspection through a risk based data driven approach described by ISO2859. SPC Visionprovides this functionality with a ‘reception control’ module which actively determinesbatch sampling quantity, pass criteria and sampling frequency. This has resulted in asignificant reduction in process time.To summarise, by embracing the forward thinking approach to quality promoted by FDAPAT, Mölnlycke have taken a real step forward: “Implementing SPC Vision has helped us toreally understand and manage our processes more effectively, resulting in a real increasein productivity & efficiency.” Jacques MARIN.Author: Ben Allister, Infodream Ltd, Published QMT Magazine, March 2010