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Article 1


Lack of Training to Blame for Slow Up-take of Continuous Improvement Tools in
Aerospace

(As featured in QMT Magazine March 2009)


Is Lack of Understanding to blame for Slow up-take of Quality Control Tools in Aerospace
Manufacturing?


Robust quality control standards achieved through continuous improvements tools (CITs)
and techniques have been a successful feature of the manufacturing industry for many
years, having been originally championed by the automotive primes. However, the
aerospace industry still lags some way behind in this area. Infodream’s director Ben Allister
argues the time has come for it to embrace proven Continuous Improvement (CI)
methodology to increase productivity through helping eliminating poor quality products
that remain unnecessarily prevalent across the aerospace manufacturing industry.


Although aerospace manufacturing is leading the way in terms of technology development,
particularly in the use carbon composites, it is a long way behind other industries in terms of
robust process planning and process control with many companies being very slow on the
up-take of proven Continuous Improvement methodology such as Statistical Process Control
(SPC), Failure Mode & Effects Analysis (FMEA) and other quality tools which can help
increase productivity. This is especially true within the supply chain.
A good example is the way in which process performance is measured. In many aerospace
companies, quality is only measured in terms of number of scrap or concessions (where the
product fails to achieve the quality standard but is allowed to pass through the process
anyway where is may be repaired further down the line or worst case at the customers final
assembly line). This type of measure is purely re-active and although providing a measure of
‘bad quality’ actually does very little to proactively reduce or avoid errors. There is a clear
need for a system in place to monitor the causes as well as the effects of bad quality. This
includes monitoring ‘right fists time’ yield (RFT), re-work, process capability (Cp & Cpk) and
SPC alarms and trends. These are the measures that really identify waste and drive process
improvement and if they are taken care of, ‘bad quality’ will naturally reduce and
productivity increase. At the moment it is undoubtedly a case of ‘wrong metrics driving
wrong behaviour’ whereby manufacturing errors are simply managed rather than their root
causes investigated and eliminated.
This behaviour was recently identified by Infodream while implementing its trademark
software - SPC Vision - on a new project at a major Aerospace company that was
experiencing repeated problems while manufacturing a large complex component. The
problem was so endemic that the component had never been manufactured ‘right first
time’. Whilst implementing Infodream’s SPC Vision software the company’s quality control
professionals began the task of analysing old non-conformance reports to identify specific
problem areas and repeat problems. After inputting all historical inspection data into SPC
Vision, the system clearly identified some areas of concern in that specific areas had a very
low process capability. This SPC & process capability data correlated exactly with the non-
conformance reports. The problems are now being addressed and the root cause
investigated but had a preventative measure such as process capability been in place from
the beginning, substantial costs could have been saved.
One of the root causes of the problem of poor quality is a lack of understanding of quality
engineering at all levels of the business. Only recently has the aerospace industry moved
away from the old concept of quality control through inspection. In addition, many
professionals continue to believe that quality tools are of relevance solely to the automotive
industry rather than being applicable to aerospace manufacturing. This misconception
stems from a fundamental lack of understanding of how the tools can help. Although many
professionals are familiar with SPC and statistical terms such as Cp (potential process
capability) & Cpk (actual process capability), they often don’t fully appreciate their proper
use and therefore struggle to relate them to process performance or product quality.




Likewise, other tools such as failure mode & effects analysis which are the backbone of the
automotive quality process are rarely implemented in the aerospace world although Airbus
has used this tool to great effect, especially during new product introduction where FMEA is
used during the development and industrialisation phases of the project to identify, quantify
and manage risk in terms of health and safety, product and process design and quality.
Additionally, many companies are focusing all of their effort on implementing ‘lean
manufacturing’ without realising that all of the different tools need to be used in
conjunction with each other to deliver maximum benefit. Undeniably implementing lean
manufacturing principles can yield huge business benefits but lean tools do not focus on
root cause analysis, variation management or process control which is where 6 Sigma, SPC
and other quality tools are required.


Although European quality standards such as ISO EN9100 are integrating quality tools into
their standards, a major culture change still needs to take place so that there is an
acceptance that a benefits driven ‘pull’ is far more effective than a simplistic quality
standard requirement. There are far too many cases where quality tools are treated as mere
‘tick in the box’ measures which is how some of the tools have received a bad reputation to
date. For the tools to be effective they really have to be accepted at all echelons of the
business, from the shop floor to the Managing Director.


In practice, this means having a clear strategy and plan which has been openly developed
and communicated across the entire company, the result being a well organised workforce
that has been trained to the required level and that possess clear objectives and metrics
which are aligned to the overall business deliverables. All of these points are critical to
successful product output and, ultimately, to a company’s success as all too often critical
projects fail due these fundamental issues.


Such is the documented evidence compiled by Infodream Ltd on the pivotal role of
Continuous Improvement tools in a company’s performance, Infodream Ltd has decided to
broaden its core business from continuous improvement training and consulting services
relating to SPC Vision to a broader range of Continuous Improvement tools. They are
offering basic one day training in SPC, FMEA, Measurement Systems Analysis and Effective
Root Cause Analysis as well as more advanced 6 Sigma training and management
introduction courses. They are offering a free days consultancy to provide an outside view
of current CI processes and identify potential opportunities for improvements.


Author: Ben Allister, Infodream Ltd, Published in QMT Magazine, March 2009
--------------------------------------------------------------------------------------------------------------------------


Article 2

SPC Vision Reduces Inspection Stages and Empowers Operators at Turbomeca UK


(As featured in QMT Magazine June 2009)


“SPC Vision 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, Turbomeca UK’s Production Manager



Company Overview: Turbomeca (UK) Ltd


Turbomeca UK 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.


Project Description:


Infodream’s SPC Vision was selected by Turbomeca UK 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. The success of the project recently featured in Turbomeca's
newsletter 'Turbine' .
Pre-Self Inspection




Prior to the project, Turbomeca’s 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 - fig1.




New Process


Turbomeca UK’s complete business process was analysed and re-engineered to dramatically
improve both efficiency and effectiveness. Infodream’s SPC Vision software is the core of
Turbomeca UK’s new process, where carefully selected key characteristics are measured at
‘SPC Inspection stations’ – fig 2.
The products are now inspected at the point of manufacture, and the measurement data is
analysed real time and stored on a central database. Previously all measurements had been
recorded manually but with the new integrated system, 95% of the measurements are now
automatically captured by linking the CMM’s, Air gauges, Height gauges and digital callipers
directly to SPC Vision.




The features measured at each inspection point are only those which are relevant to the
associated manufacturing step so there is no duplication. With the products being inspected
and data recorded at each step of the process, the final inspection has been eliminated. The
product conformance report is generated automatically by SPC Vision at the end of the
process. Non-conforming products are also detected much earlier in the process at the point
of manufacture, reducing scrap, rework and processing costs. Additionally SPC Vision is used
to monitor and control the process, so trends and early warning signs are detected and
actions taken prior to manufacturing problems occurring.



Turbomeca production manager Malcolm Smithers says that that “SPC Vision 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.”


With phase 1 of the project almost complete, Turbomeca are now looking to utilise the
statistical process control (SPC) and analysis features provided by Infodream’s SPC Vision to
monitor, control and improve machine and process performance. Malcolm says that
"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”


Turbomecca have already began the next stage of the journey by sending all of their
production operators on a ‘Variation Reduction & Statistical Process Control’ training
workshop provided by Infodream. This proved to be a very good insight for the shopfloor
personnel into what benefits could be delivered and what their role would be in this new
way of working. Machining quality co-ordinator John Atkinson commented that the course
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”


Turbomeca UK Contacts:

Malcolm Smithers - Pneumatic production manager

Email: msmithers@turbomeca.co.uk


Author: Ben Allister, Infodream Ltd, Published in QMT Magazine, June 2009


--------------------------------------------------------------------------------------------------------------------------

Article 3


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.




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 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
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

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Infodream Articles about Continuous Improvement, Aerospace, Quality Control and SPC Vision

  • 1. Article 1 Lack of Training to Blame for Slow Up-take of Continuous Improvement Tools in Aerospace (As featured in QMT Magazine March 2009) Is Lack of Understanding to blame for Slow up-take of Quality Control Tools in Aerospace Manufacturing? Robust quality control standards achieved through continuous improvements tools (CITs) and techniques have been a successful feature of the manufacturing industry for many years, having been originally championed by the automotive primes. However, the aerospace industry still lags some way behind in this area. Infodream’s director Ben Allister argues the time has come for it to embrace proven Continuous Improvement (CI) methodology to increase productivity through helping eliminating poor quality products that remain unnecessarily prevalent across the aerospace manufacturing industry. Although aerospace manufacturing is leading the way in terms of technology development, particularly in the use carbon composites, it is a long way behind other industries in terms of robust process planning and process control with many companies being very slow on the up-take of proven Continuous Improvement methodology such as Statistical Process Control (SPC), Failure Mode & Effects Analysis (FMEA) and other quality tools which can help increase productivity. This is especially true within the supply chain.
  • 2. A good example is the way in which process performance is measured. In many aerospace companies, quality is only measured in terms of number of scrap or concessions (where the product fails to achieve the quality standard but is allowed to pass through the process anyway where is may be repaired further down the line or worst case at the customers final assembly line). This type of measure is purely re-active and although providing a measure of ‘bad quality’ actually does very little to proactively reduce or avoid errors. There is a clear need for a system in place to monitor the causes as well as the effects of bad quality. This includes monitoring ‘right fists time’ yield (RFT), re-work, process capability (Cp & Cpk) and SPC alarms and trends. These are the measures that really identify waste and drive process improvement and if they are taken care of, ‘bad quality’ will naturally reduce and productivity increase. At the moment it is undoubtedly a case of ‘wrong metrics driving wrong behaviour’ whereby manufacturing errors are simply managed rather than their root causes investigated and eliminated.
  • 3. This behaviour was recently identified by Infodream while implementing its trademark software - SPC Vision - on a new project at a major Aerospace company that was experiencing repeated problems while manufacturing a large complex component. The problem was so endemic that the component had never been manufactured ‘right first time’. Whilst implementing Infodream’s SPC Vision software the company’s quality control professionals began the task of analysing old non-conformance reports to identify specific problem areas and repeat problems. After inputting all historical inspection data into SPC Vision, the system clearly identified some areas of concern in that specific areas had a very low process capability. This SPC & process capability data correlated exactly with the non- conformance reports. The problems are now being addressed and the root cause investigated but had a preventative measure such as process capability been in place from the beginning, substantial costs could have been saved.
  • 4. One of the root causes of the problem of poor quality is a lack of understanding of quality engineering at all levels of the business. Only recently has the aerospace industry moved away from the old concept of quality control through inspection. In addition, many professionals continue to believe that quality tools are of relevance solely to the automotive industry rather than being applicable to aerospace manufacturing. This misconception stems from a fundamental lack of understanding of how the tools can help. Although many professionals are familiar with SPC and statistical terms such as Cp (potential process capability) & Cpk (actual process capability), they often don’t fully appreciate their proper use and therefore struggle to relate them to process performance or product quality. Likewise, other tools such as failure mode & effects analysis which are the backbone of the automotive quality process are rarely implemented in the aerospace world although Airbus has used this tool to great effect, especially during new product introduction where FMEA is used during the development and industrialisation phases of the project to identify, quantify and manage risk in terms of health and safety, product and process design and quality. Additionally, many companies are focusing all of their effort on implementing ‘lean manufacturing’ without realising that all of the different tools need to be used in
  • 5. conjunction with each other to deliver maximum benefit. Undeniably implementing lean manufacturing principles can yield huge business benefits but lean tools do not focus on root cause analysis, variation management or process control which is where 6 Sigma, SPC and other quality tools are required. Although European quality standards such as ISO EN9100 are integrating quality tools into their standards, a major culture change still needs to take place so that there is an acceptance that a benefits driven ‘pull’ is far more effective than a simplistic quality standard requirement. There are far too many cases where quality tools are treated as mere ‘tick in the box’ measures which is how some of the tools have received a bad reputation to date. For the tools to be effective they really have to be accepted at all echelons of the business, from the shop floor to the Managing Director. In practice, this means having a clear strategy and plan which has been openly developed and communicated across the entire company, the result being a well organised workforce that has been trained to the required level and that possess clear objectives and metrics which are aligned to the overall business deliverables. All of these points are critical to successful product output and, ultimately, to a company’s success as all too often critical projects fail due these fundamental issues. Such is the documented evidence compiled by Infodream Ltd on the pivotal role of Continuous Improvement tools in a company’s performance, Infodream Ltd has decided to broaden its core business from continuous improvement training and consulting services relating to SPC Vision to a broader range of Continuous Improvement tools. They are offering basic one day training in SPC, FMEA, Measurement Systems Analysis and Effective Root Cause Analysis as well as more advanced 6 Sigma training and management introduction courses. They are offering a free days consultancy to provide an outside view of current CI processes and identify potential opportunities for improvements. Author: Ben Allister, Infodream Ltd, Published in QMT Magazine, March 2009
  • 6. -------------------------------------------------------------------------------------------------------------------------- Article 2 SPC Vision Reduces Inspection Stages and Empowers Operators at Turbomeca UK (As featured in QMT Magazine June 2009) “SPC Vision 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, Turbomeca UK’s Production Manager Company Overview: Turbomeca (UK) Ltd Turbomeca UK 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. Project Description: Infodream’s SPC Vision was selected by Turbomeca UK 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. The success of the project recently featured in Turbomeca's newsletter 'Turbine' .
  • 7. Pre-Self Inspection Prior to the project, Turbomeca’s 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 - fig1. New Process Turbomeca UK’s complete business process was analysed and re-engineered to dramatically improve both efficiency and effectiveness. Infodream’s SPC Vision software is the core of Turbomeca UK’s new process, where carefully selected key characteristics are measured at ‘SPC Inspection stations’ – fig 2.
  • 8. The products are now inspected at the point of manufacture, and the measurement data is analysed real time and stored on a central database. Previously all measurements had been recorded manually but with the new integrated system, 95% of the measurements are now automatically captured by linking the CMM’s, Air gauges, Height gauges and digital callipers directly to SPC Vision. The features measured at each inspection point are only those which are relevant to the associated manufacturing step so there is no duplication. With the products being inspected and data recorded at each step of the process, the final inspection has been eliminated. The product conformance report is generated automatically by SPC Vision at the end of the process. Non-conforming products are also detected much earlier in the process at the point of manufacture, reducing scrap, rework and processing costs. Additionally SPC Vision is used to monitor and control the process, so trends and early warning signs are detected and actions taken prior to manufacturing problems occurring. Turbomeca production manager Malcolm Smithers says that that “SPC Vision has enabled both a large number of measurement and inspection stages to be removed and
  • 9. empowered the operators to achieve consistently high standards. It has really helped us achieve standard times and is already improving our profitability.” With phase 1 of the project almost complete, Turbomeca are now looking to utilise the statistical process control (SPC) and analysis features provided by Infodream’s SPC Vision to monitor, control and improve machine and process performance. Malcolm says that "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” Turbomecca have already began the next stage of the journey by sending all of their production operators on a ‘Variation Reduction & Statistical Process Control’ training workshop provided by Infodream. This proved to be a very good insight for the shopfloor personnel into what benefits could be delivered and what their role would be in this new way of working. Machining quality co-ordinator John Atkinson commented that the course 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” Turbomeca UK Contacts: Malcolm Smithers - Pneumatic production manager Email: msmithers@turbomeca.co.uk Author: Ben Allister, Infodream Ltd, Published in QMT Magazine, June 2009 -------------------------------------------------------------------------------------------------------------------------- Article 3 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
  • 10. 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. 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.
  • 11. 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 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
  • 12. 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 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