We can now look forward to increased efficiency, and a huge saving in our time – which, put simply – is priceless.

Jacques MARIN

Mölnlycke is one of the world’s leading suppliers of single-use products for surgical and wound care services in the healthcare sector.

By using Infodream’s Qualaxy SPC software, Mölnlycke has significantly reduced processing time, rework, scrap, inspection time and eliminated the problem of ShopFloor document control.

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.

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 Qualaxy SPC 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 Qualaxy SPC 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 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 Qualaxy SPC we have seen a significant reduction in scrap and re-processing which has noticeably improved the efficiency of the manufacturing process.

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. Qualaxy SPC 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 Qualaxy SPC has helped us to really understand and manage our processes more effectively, resulting in a real increase in productivity & efficiency.

Jacques MARIN

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Safran Helicopter Engines specialises in the manufacture of complex mechanical assemblies for the aerospace industry and the maintenance, repair and overhaul (MRO) of small/medium size gas turbines. The company forms part of the global group of SAFRAN, whose subsidiary companies are located in over 30 countries around the world and who employ over 61,000 staff.

Qualaxy SPC has enabled a large number of measurements to be made and verification steps to be eliminated. This allows operators to achieve significantly higher compliance rates. It is already improving our profitability.

Projet description

CT Infodream’s Qualaxy SPC was selected by Safran Helicopter Engines after a 3 month trial period, to facilitate their key lean manufacturing project called ‘Self Inspection’. The project’s initial objective was to re-engineer the production inspection process to increase its efficiency and effectiveness. The project was no small task requiring a major cultural change and new ways of shop floor working.

Pre-Self Inspection

Prior to the project, Safran Helicopter Engines’ products were inspected several times during the manufacturing process. Each inspection step was conducted in isolation, often repeating measurements from previous steps. Additionally, each product underwent a thorough final inspection where the part was either passed and a certification report generated or failed and the required action taken. Undertaking the final inspection at the end of the process also meant that non-conforming products were sometimes not detected until this stage of the process, by which time much value has been added through each manufacturing step resulting in much higher scrap and rework costs.

New process

The entire production process has been analysed and reorganised to significantly improve its performance and efficiency. Qualaxy SPC software is at the heart of Safran Helicopter Engines’ new production process, where the main characteristics are evaluated by the « SPC control stations ».

Products are now checked at the time of manufacture, measurements are analysed in real time and stored in a central database. Previously, all measurements were entered by hand, but with this new integrated system, 95% of measurements are automatically recorded in Qualaxy SPC via measuring instruments (digital calipers, air gauges, scales, etc.).

The characteristics measured at each inspection point are only those relevant to the associated manufacturing step, so there is no duplication. As the products are controlled and the data recorded at each stage of the process, the final control has been eliminated. The product conformity report is automatically generated by Qualaxy SPC at the end of the process. Non-conforming products are also identified much earlier in the manufacturing process, thus reducing scrap and rework costs and process costs. In addition, Qualaxy SPC can detect trends and trigger alarms, so action is taken before manufacturing problems occur.

Qualaxy SPC has enabled both a large number of measurement and inspection stages to be removed and empowered the operators to achieve consistently high standards. It has really helped us achieve standard times and is already improving our profitability.

Malcolm Smithers
Safran Helicopter Engines production manager

With phase 1 of the project almost complete, Safran Helicopter Engines are now looking to utilise the statistical process control (SPC) and analysis features provided by Infodream’s Qualaxy SPC to monitor, control and improve machine and process performance.

Although this was outside the original scope of the project, there are clear benefits in using SPC on the shopfloor and we feel that this could really help us reduce waste and manufacturing failures in the future.

Malcolm Smithers
Safran Helicopter Engines production manager

Safran Helicopter Engines has already taken the next step by sending all operators to a « Variation Reduction and Statistical Process Control » training course run by Infodream Ltd. This has proved to be very positive, enabling the shop floor staff to understand this new way of working and the benefits it can bring them.

The training had expelled a few myths and misconceptions surrounding SPC and has given me a much better understanding and confident view of how to apply it.

John Atkinson,
co-manager of machining quality

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The Safran Aircraft Engines site in Evry-Corbeil employs 2,800 people on a 72-hectare site; it has an 88 000 m2 workshop and a fleet of over 800 machines.

This site is responsible for the machining and assembly of parts and sub-assemblies for civil and military aircraft engines.

For LYNRED, continuous improvement is a never-ending road…

Vincent De Schuyteneer, data expert engineer at LYNRED, explains how his company is constantly improving its manufacturing processes with the Qualaxy SPC software.

Who’s LYNRED?

Why choose CT INFODREAM’s solution?

In order to guarantee our customers state-of-the-art products, it was essential to implement a powerful industrial tool for monitoring manufacturing processes.

A solution that was quickly adopted by the various trades.

The operators very quickly adopted this new tool, which enabled them to see the evolution of production in real time and to immediately escalate problems to the support/engineering department.

Vincent De Schuyteneer,
Data Expert Engineer at LYNRED
www.lynred.com

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