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QUALITY MANAGEMENT PROJECT Injection Moulding Validation Lead Time Reduction Student Name

QUALITY MANAGEMENT PROJECT
Injection Moulding Validation Lead Time Reduction

Student Name: Michelle Martin – X00082900
Exam Number: 2018-D2-TA-164
Academic Lecturer: Mark Connolly
Award: EIQA Diploma
Course Title: EIQA Diploma in Quality Management
Year of Submission: 2018 Year 2
AbstractIn modern day’s competitive market place, organisations call for short lead times, small costs and increased customer service to continue. The purpose of this study was to reduce the lead time for the injection moulding validation process within Nypro Bray by utilising the lean Philosophy to eliminate waste and the Six Sigma  technique for solving problems efficiently.

Data was collected by applying the Lean Six Sigma tools to the current injection moulding validation process and by working with key stakeholders of the process to understand and identify potential root causes for the extended Lead time. This information was then used to formulate improvement activities. Measurable data was used to create a measurement baseline and to select the most appropriate metrics for tracking, monitoring and evaluating whether the changes implemented were controllable and sustainable. Improvement activities and process changes were executed within the process.

The outcome of this project was the reduction of the Injection Moulding Validation Process Lead time from 117 days to 35.5 days, which in turn reduced the labour cost for completing a validation from €28k to €8.5k which resulted in a cost savings for Nypro. Based on this project the Lean Six Sigma approach offers a beneficial structure and set of tools for improving a process. The tools are helpful for determining a baseline, gathering and analysing data and potential root causes and executing changes in a controllable way to achieve sustainability. In order to maintain the reduction in lead time, the author recommends that Nypro should continue with monitoring and controlling the improvement activities and focusing on communication and training with regards to the Injection Moulding Validation Process.

DeclarationI hereby declare that the project report entitled “Injection Moulding Validation Lead Time Reduction” submitted by me to the Institute of Technology Tallaght Dublin (ITT Dublin), as part of the Award for the EIQA Diploma in Quality Management, is a record of my own original work and has not been submitted to any other Institute or University for any other Degree or Diploma or any other award in whole or in part, except where states otherwise by reference or acknowledgment.

Signed:____________________Date:_____________
MICHELLE MARTIN Date
AcknowledgementI would like to express my utmost appreciation to my colleagues who have assisted and supported me throughout this project. I am appreciative to the key Project Team members for continuous support from timely advice ; links in the early stages of theoretical initiation and through ongoing advice and encouragement to this day.

A special thank you of mine goes to my colleagues who helped me in completing this project and exchanging interesting ideas and thoughts.
Below are names of each person and their job role that has contributed to my work and project within Company Nypro:
NameJob Title
RMcEManufacturing Engineering Manager
KHGeneral Manager
SBManufacturing Engineer Lead
WLTooling Supervisor
DO’LSite Quality Manager
MMValidation Engineer
PBProcess Engineer
RBPrograms Engineer
The list of tasks completed by me can be seen in section 4.1.3, Figure 19.

Table of Contents
TOC o “1-3” h z u Abstract PAGEREF _Toc510800648 h 2Declaration PAGEREF _Toc510800649 h 3Acknowledgement PAGEREF _Toc510800650 h 4List of Figures PAGEREF _Toc510800651 h 8List of Tables PAGEREF _Toc510800652 h 9List of Abbreviations PAGEREF _Toc510800653 h 101.Chapter 1- Introduction & Background PAGEREF _Toc510800654 h 111.1.Introduction PAGEREF _Toc510800655 h 111.2.Company Background PAGEREF _Toc510800656 h 112.Chapter 2- Aims and Objectives PAGEREF _Toc510800657 h 142.1.Problem statement PAGEREF _Toc510800658 h 142.2.Objectives PAGEREF _Toc510800659 h 152.3.Deliverables PAGEREF _Toc510800660 h 152.4.Scope PAGEREF _Toc510800661 h 153.Chapter 3-Literature Review PAGEREF _Toc510800662 h 163.1.Lean Six Sigma PAGEREF _Toc510800663 h 163.2.Lead Time Reduction (Why?) PAGEREF _Toc510800664 h 163.2.1.Lead Time Reduction PAGEREF _Toc510800665 h 173.2.2.A Reflection of Lead time PAGEREF _Toc510800666 h 183.2.3.Why Reduce Lead Time? PAGEREF _Toc510800667 h 183.2.4.Reducing Lead time PAGEREF _Toc510800668 h 183.3.Process Validation PAGEREF _Toc510800669 h 193.3.1.Validation PAGEREF _Toc510800670 h 193.3.2.Moulding Process Validation Pre-Requisites PAGEREF _Toc510800671 h 203.3.3.Moulding Validation Requirements & Phases PAGEREF _Toc510800672 h 213.4.Injection Moulding PAGEREF _Toc510800673 h 243.4.1.Injection Moulding Machine PAGEREF _Toc510800674 h 253.4.2.The injection mould process PAGEREF _Toc510800675 h 253.5.Lean Six Sigma Tools for Problem Solving PAGEREF _Toc510800676 h 263.5.1.PDCA Cycle PAGEREF _Toc510800677 h 273.5.2.The DMAIC Model PAGEREF _Toc510800678 h 273.5.3.Define PAGEREF _Toc510800679 h 273.5.4.Measure PAGEREF _Toc510800680 h 303.5.5.Analyse PAGEREF _Toc510800681 h 313.5.6.Improve PAGEREF _Toc510800682 h 333.5.7.Control PAGEREF _Toc510800683 h 344.Chapter 4- Methodology PAGEREF _Toc510800684 h 344.1.Current State Analysis PAGEREF _Toc510800685 h 344.1.1.Case Organisation PAGEREF _Toc510800686 h 344.1.2.Problem Statement & Goals PAGEREF _Toc510800687 h 354.1.3.Measurement & Data Collection PAGEREF _Toc510800688 h 354.2.Team Building PAGEREF _Toc510800689 h 364.3.Defining the Baseline PAGEREF _Toc510800690 h 384.4.Preparing the Improvement Plan PAGEREF _Toc510800691 h 404.4.1.Checklist Pre-Approval PAGEREF _Toc510800692 h 414.4.2.Completion of Checklist PAGEREF _Toc510800693 h 424.4.3.Validation Production Record PAGEREF _Toc510800694 h 434.4.4.Predysis, Cpk Analysis & Reporting PAGEREF _Toc510800695 h 434.4.5.Generic Setting Sheets & FAI, SAT and OQ Setting Sheets PAGEREF _Toc510800696 h 464.4.6.Attachments PAGEREF _Toc510800697 h 474.4.7.Resources, Capacity and Autonomy PAGEREF _Toc510800698 h 484.5.Executing Improvements PAGEREF _Toc510800699 h 484.6.Control PAGEREF _Toc510800700 h 505.Chapter 5- Results and Analysis PAGEREF _Toc510800701 h 505.1.Results PAGEREF _Toc510800702 h 506.Chapter 6 Discussion PAGEREF _Toc510800703 h 556.1.Discussion and Results PAGEREF _Toc510800704 h 556.2.Issues Encountered PAGEREF _Toc510800705 h 566.3.Recommendations & Further Opportunities PAGEREF _Toc510800706 h 566.4.Conclusion PAGEREF _Toc510800707 h 577.Chapter 7-References PAGEREF _Toc510800708 h 58Appendices PAGEREF _Toc510800709 h 61Appendix A PAGEREF _Toc510800710 h 61Appendix B PAGEREF _Toc510800711 h 62Appendix B.1 Installation Qualification PAGEREF _Toc510800712 h 62Appendix B.2 First Article Inspection PAGEREF _Toc510800713 h 62Appendix B.3 Site Acceptance Testing PAGEREF _Toc510800714 h 62Appendix B.4 Operational Qualification PAGEREF _Toc510800715 h 63Appendix B.5 Performance Qualification PAGEREF _Toc510800716 h 64Appendix C PAGEREF _Toc510800717 h 65Appendix D PAGEREF _Toc510800718 h 66Appendix E PAGEREF _Toc510800719 h 67Appendix F PAGEREF _Toc510800720 h 68Appendix G PAGEREF _Toc510800721 h 69

List of Figures TOC h z c “Figure” Figure 1: Nypro Ireland Value Streams PAGEREF _Toc510800722 h 12Figure 2: Process Approach for QMS PAGEREF _Toc510800723 h 13Figure 3: Lead Time PAGEREF _Toc510800724 h 17Figure 4: Lead Time Reduction PAGEREF _Toc510800725 h 17Figure 5: Demand Variation Vs. Cost PAGEREF _Toc510800726 h 18Figure 6: Lean Toolbox of Tools PAGEREF _Toc510800727 h 19Figure 7: Injection Moulding Machine 17 PAGEREF _Toc510800728 h 26Figure 8: PDCA & DMAIC 18 PAGEREF _Toc510800729 h 26Figure 9: PDCA 19 PAGEREF _Toc510800730 h 27Figure 10: DMAIC PAGEREF _Toc510800731 h 27Figure 11: SIPOC Diagram 23 PAGEREF _Toc510800732 h 29Figure 12: Team Building 27 PAGEREF _Toc510800733 h 30Figure 13: RACI Chart 28 PAGEREF _Toc510800734 h 30Figure 14: Process Map 30 PAGEREF _Toc510800735 h 31Figure 15: Pareto Chart PAGEREF _Toc510800736 h 32Figure 16: Affinity Diagram PAGEREF _Toc510800737 h 32Figure 17: Ishikawa Diagram PAGEREF _Toc510800738 h 33Figure 18: Control Chart PAGEREF _Toc510800739 h 34Figure 19: Team RACI PAGEREF _Toc510800740 h 37Figure 20: Validation Process SIPOC PAGEREF _Toc510800741 h 38Figure 21: Defining the Process Baseline PAGEREF _Toc510800742 h 38Figure 23: Pareto of Validation Phases PAGEREF _Toc510800743 h 39Figure 24: Categorised Affinity Diagram following Brainstorming PAGEREF _Toc510800744 h 40Figure 25: Ishikawa Diagram for Process Validation PAGEREF _Toc510800745 h 41Figure 26: Capability and Probability Graphs PAGEREF _Toc510800746 h 45Figure 27: Capability and Probability graphs per Cavity PAGEREF _Toc510800747 h 45Figure 28: Process Setting Sheet PAGEREF _Toc510800748 h 46Figure 29: Validation Stamp PAGEREF _Toc510800749 h 47Figure 30: Validation Activities Average Days Prior Vs. Post Improvement PAGEREF _Toc510800750 h 51Figure 31: Checklist Pre-Approval Average Days Prior Vs. Post Improvement PAGEREF _Toc510800751 h 51Figure 32: Checklist Completion Average Days Prior Vs. Post Improvement PAGEREF _Toc510800752 h 52Figure 33: Predysis, Cpk Analysis & Reporting Average Days Prior Vs. Post Improvement PAGEREF _Toc510800753 h 53Figure 34: Attachments Average Days Prior Vs. Post Improvement PAGEREF _Toc510800754 h 53Figure 35: Average Days to complete Metrology Prior Vs. Post Improvement PAGEREF _Toc510800755 h 54

List of Tables TOC h z c “Table”
Table 1: Process Parameters and Window PAGEREF _Toc510800756 h 21Table 2: 10 Step PDCA Improvement Strategies PAGEREF _Toc510800757 h 36Table 3: Validation Cost PAGEREF _Toc510800758 h 39Table 4: 5 why Question to begin PAGEREF _Toc510800759 h 40Table 5: Checklist Pre-Requisite Information PAGEREF _Toc510800760 h 42Table 6: Checklist Non-Value Added Activities PAGEREF _Toc510800761 h 43Table 7: Validation Production Record Non-Value Added Activities PAGEREF _Toc510800762 h 43Table 8: Minitab Data Arrangement PAGEREF _Toc510800763 h 44Table 9: Cpk Summary Table PAGEREF _Toc510800764 h 44Table 10: Checklist Attachments PAGEREF _Toc510800765 h 47Table 11: Improvement Plan PAGEREF _Toc510800766 h 48Table 12: Cost Savings PAGEREF _Toc510800767 h 54

List of AbbreviationsPDCA Plan Do Check Act
SMART Specific, Measurable, Achievable, Relevant & Time Bound
DMAIC Define Measure Analyse Improve Control
QPM Quality Plan Moulding
QMS Quality Management System
SPC Statistical Process Control
CAPA Corrective Action, Preventative Action
cGmpCurrent Good Manufacturing Practices
QSR Quality System Regulation
CFR Code of Federal Regulation
LSS Lean Six Sigma
QbDQuality by Design
WIP Work in Progress
ISO International organisation for Standardisation
BIQ Built in Quality
FDA Food and Drug Administration
URS User Requirement Specification
PD Process Development
FAT Factory Acceptance Testing
FAI First Article Inspection
IQ Installation Qualification
SAT Site Acceptance Testing
OQ Operational Qualification
PQ Performance Qualification
CT Scan Computed Tomography Scan
NWQS Nypro Worldwide Quality System
RACI Responsible, Accountable, Consult, Inform
PVR Process Validation Report
CPK Process Capability Index
IMM Injection Moulding Machine
Chapter 1- Introduction & BackgroundIntroductionThe focus of the report work is an improvement project based on lean six sigma processes for a leading manufacturer in High Precision Injection Moulding (Nypro). The project is based in particular on reducing the Injection Moulding Validation process lead time and throughput, as this is a significant topic for manufacturing projects. The 21st century competitive market is changing rapidly and has become more and more competitive to satisfy the customer 2. For example, to work in a worldwide market, short lead times are essential to provide new products and customer satisfaction.

Reductions in Injection Moulding Validation process throughput and lead time can create many benefits, including a drop in work in process (WIP) and finished goods (FG) inventory, improved quality, decreased cost and a reduced amount of forecasting errors. Above all, reductions in process throughput and lead time, increases flexibility and decreases the time involved to react to and meet the customer needs and demands. This is vital for the endurance and productivity of many businesses, especially for those with increased or new market pressures for shorter validation lead times of customised products.

Process validation is a regulatory requirement and incorporates the principle of Quality by Design (QbD). It also can highlight issues with a system, tool or process prior to starting GMP production. Effective process validation contributes considerably to assuring product quality. The basic principle of quality assurance is that the product produced is fit for its intended use.
To adapt to the industry competition, Nypro is seeking techniques to reduce the validation process lead time, by reducing 90-95% of non-value add activities. This is required in order to meet new project timelines and new customer expectations. The customer does not want to pay for non-value added activities within a process (Corner 2001).

Company BackgroundThis project was done as part of an improvement project for a leading manufacturer in High Precision Injection Moulding Company that design, develop and manufacture drug delivery systems for healthcare and pharmaceutical companies worldwide.

Nypro Healthcare Ireland, a Jabil Company, is a leading manufacturer in high precision injection moulding. Nypro healthcare provides drug delivery systems to healthcare and pharmaceutical customers with wide ranges of design and manufacturing expertise in the industry 3. Nypro’s assorted suite of competencies aids the customer to invent and transfer products to the market rapidly and consistently with 4:
Advanced mechanical solutionsPlastic insert moulding
Machining Electronics in Drug Delivery
Rapid prototyping services AutomationNypro Healthcare is in operation in 90 sites across 23 countries and each site manufacture a range of different products 4. Nypro Healthcare Ireland consists of two facilities (Bray ; Waterford). Both sites focus on design, development, moulding and assembly of drug delivery systems, such as subcutaneous drug delivery systems (Needle Based and Needle Free Injection Devices), Inhaler devices (Manual dose with ; without dose counter, Breadth Activated ; Dry powder), syringes, reagent cartridges, Filtration Devices and renal care device components. Nypro Bray comprises of fifty plus (50+) injection moulding machines (IMM), with another seventy-two to arrive over the coming months , ten fully computerised assembly lines, five ISO Class 8 clean rooms, along with one cleanroom which has been decommissioned and another cleanroom which is in the process of being classified and commissioned for use and two fully equipped Quality Assurance (QA) Labs containing multiple types of measuring systems 5.

Nypro Bray and Waterford sites are broken into value streams and each value stream consists of a different customer, product/products and processes

Figure SEQ Figure * ARABIC 1: Nypro Ireland Value StreamsDrug Delivery Systems manufactured for Pharmaceutical customers are moulded and assembled in controlled cleanroom environments which function to an ISO Class 8 standard, as per ISO 14644-1.

Both sites comply with the ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes
Nypro Ireland has created and implemented a QMS in agreement with applicable Nypro Healthcare and Regulatory requirements and is committed to its continual improvement. Nypro Ireland applies a process approach in abstracting its QMS 6. The outputs of one process in the QMS aid as an input to another process as seen in Figure 2 below.

.

Figure SEQ Figure * ARABIC 2: Process Approach for QMSNypro QMS is based ISO 9001 Quality Management Systems- Requirements and ISO 13485 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes in full compliance with current Good Manufacturing Practice (cGMP). In addition, Nypro provides a commitment to the following where applicable and when required by the customer quality agreement 7:
21 CFR Part 820, Quality System Regulation Medical Device Quality Systems Manual – HHS Publication FDA 97-4179
EU Medical Device Directive ISO 15378 (Primary Packaging)
Canadian Medical Device Regulation ISO 14644 (Suite of Standards for Controlled Environments)
Japan MHLW Ordinance 169 ISO 14971 (Risk Management)
The fundamental part of the quality management system in Nypro, is the Nypro Worldwide Quality System (NWQS). NWQS connects the generation and approval of documents and Corrective Action Preventive Action (CAPA) applications across all Nypro sites and it also maintains the following 7:
Master Validation Plans Validation Reports
Application Validation Plans End user Procedures and Work Instructions
Design Specifications Template Definition
Validation Checklists System Qualification and Maintenance
Electronic Signature Checklists Hardware and Software Change Control
Nypro have also established and validated a worldwide web-based Statistical Process Control (SPC) system, which is called Predisys. This system is designed with Moulding and standard SPC settings and allows for the gathering of both variable and attribute data. The system delivers a selection of reports to analyse data for internal process control as well as for meeting the data reporting necessities of the customer8.

Chapter 2- Aims and ObjectivesThe overall aim of this improvement project was to seek techniques to improve and reduce the Injection Moulding Validation Process Lead Time from 3-6 months (Average 117 Days) to 5 (25 Days) weeks and lower the non-value added activities by 90-95%.

Note: The average days calculated is based on a 5 day week.

Problem statementTime is money and a shorter process lead time and throughput is a continuous importance for a manufacturing company and its customer. With new projects (products) being introduced into Nypro, there is a high volume of Moulding Tool Validations required prior to the production and manufacture of these new products. Over the coming months, 70+ new mould tools will arrive on site and each will require a validation. Currently a moulding tool validation can take from 3-6 months to complete. This has a huge impact on resources, production, customer satisfaction ; demand and revenue. This project was required in order to meet new project timelines and new customer expectations. The customer does not want to pay for non-value added activities within a process (Corner 2001).

ObjectivesThe objective of this project was to improve and reduce the Injection Moulding Validation Process Lead Time from 3-6 months to 5 weeks and lower the non-value activities by 90-95% and in succession reduce the cost to complete a validation. The objectives of the project were to:
Outline the project goals and intents
Choose key metrics to use
Identify possible root causes in order to formulate an improvement plan
Implement the required changes by using Lean Production and six sigma methodologies and tools
DeliverablesThe key deliverables of this improvement project were:
Reduction in Lead time for the injection moulding validation process
Reduction of non-value added activities and cost savings
Clearer RACI, clearer accountability
Increased autonomy for moulding engineers with elements to complete
Clear deliverables from moulding engineer to quality for signoff
ScopeThe scope of this project is limited to the Injection Moulding Validation Process and the analysis was focused on the validation activities (FAI,IQ_SAT, OQ ; PQ). The project management SMART and the Lean Six sigma methodologies was used during this project.

Chapter 3-Literature ReviewThis chapter will describe the topics related to Process Validation Lead Time Reduction and the implementation of this project, such as Lean, Six Sigma, Lead Time and Process Validation. The main focus of this section will be the Lead Time Reduction methodology and Tools used for Problem Solving, as the project will be completed in a Lean Six sigma manner.

Lean Six SigmaLean is a popular philosophy for streamlining manufacturing and service processes by removing waste while maintaining supply value to customers. Six Sigma is a technique for solving problems efficiently. Operating in a Six Sigma fashion reduces the quantity of defective products produced or services provided, which in turn results in an increase in revenue and customer satisfaction 9.

Lean Six Sigma (LSS) is a combination of two dominant process improvement methods. LSS decreases your organisations costs by removing “Waste” from a process. Waste is any non-value add activity that isn’t required to manufacture a product or provide a service 9.

Companies face increasing costs and greater competition daily. Lean Six Sigma allows organisations to battle these difficulties and develop their business the following ways 9:
Increase Profit
Decrease Costs
Improves Efficiency & Effectiveness
Helps Develop People/Employees
Lead Time Reduction (Why?)Any lean project aims to reduce waste and increase speed of a process. Increasing velocity links to reducing lead time for your customer. Reducing waste comprises of an analysis of present inventory and steps to reduce that inventory 10. Every product or service has a specific deliverable time period from demand of customer to product or service supply. This total time is encapsulated in the term lead time. A longer lead time can increase the opportunity to generate waste, quality issues and excess cost
Lead Time ReductionLead time is the delay between the start and implementation of a process. For example, the lead time between the placement of an order and delivery of that order, which also includes all the in process wastes, such as wait time 11.

Figure SEQ Figure * ARABIC 3: Lead TimeThe total Lead time includes all the inefficiencies of waiting time, transportation, rework etc.

So what is lead time reduction? Lead time reduction is the focus of streamlining a process, by eliminating waste and working toward one piece flow. Lead time reduction is an approach using many different strategies, tools and methods to deliver products and services as quick as possible. Flow is required in order to reduce lead time 11.

Figure SEQ Figure * ARABIC 4: Lead Time ReductionLittle’s Law
Little’s Law offers a calculation for describing the relationship between Lead Time, Work-in-Process (WIP) and throughput for any process. Little’s Law states that the average Lead Time is directly proportional to the throughput and WIP 12.

Process Lead Time = WIP / Throughput Rate
There are two methods of calculating process lead time:
The time a part or document enters the process to the time it gets into the next process.
If there are a WIP/ queue waiting process that would also be calculated as lead time.

A Reflection of Lead timeThe higher the variation in your process demand, the higher the importance to reduce the lead time and add flexibility to the process.

Figure SEQ Figure * ARABIC 5: Demand Variation Vs. CostThe chart above illustrates the relationship between process demand variation and cost. The increase in demand variation increases inventory, equipment and resources to provide a similar output. If the lead time is reduced, the cost reduces even though the demand variation remains the same 11.

Why Reduce Lead Time?Implementing lean has many benefits (improved quality, safety, less waste). The main benefit that is pursued is reducing lead time as it allows all the other benefits to sustain over time. When lead time reduction is achieved many other benefits are recognised. However, one must ensure not to increase process speed at the expense of resources. Overburdening resources with unreasonable expectations will prevent the transformation from becoming sustainable 11.

Reducing Lead timeThere are many obstacles in reducing lead time. Fortunately, there is a lean toolbox of tools and systems that can assist in overcoming those obstacles.

Figure SEQ Figure * ARABIC 6: Lean Toolbox of ToolsPrior to attempting the implementation of the above concepts seen in figure x, the process team should understand the stability of their process as well as quality control within their process. Without either of those concepts in place, reducing the lead time of the process will have an increased likelihood to fail. To prevent failure, the team must ensure process stability and Built in Quality (BIQ) in the process 11.
Lead time is present in every step of a process. Every moment where there is movement, storage, inspections, processes, scheduling, or purchasing an item can add to the total lead time of the entire process. As you review the process map or SIPOC diagram (which is discussed later on in this chapter), the data that has been collected during these mapping exercises will determine the points within the process that cause the most lead time and areas that can be addressed and improved 11.

Process ValidationValidation
Validation means “confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled”.(21 CFR 820.3 (z) )
Process Validation means “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications & quality attributes”.(FDA Guidance: Process Validation: General Principles ; Practices Jan 2011)
There are 3 stages of Process Validation:
Stage 1 – Process Design
Stage 2 – Process Qualification
Stage 3- Continued Process Verification.

This project will only look at the Process Qualification aspect of the validation.

Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. (21 CFR 820.75(a) )As per 21 CFR 820.80 a process validation shall be completed prior to release of a finished device. Each company will ensure that all equipment used in the production process of a finished good, will meet specified requirements and is appropriately designed, built, placed and installed to enable maintenance, adjustment, cleaning and use. (21 CFR 820.70 (g) )Effective process validation adds considerably to assuring product quality. The basic value of quality assurance is that the product should be manufactured that it is fit for its planned use.

Moulding Process Validation Pre-RequisitesThere are 3 important elements that must be addressed prior to commencing Moulding Process Validation. These consist of Tool Design, Measuring System and Robust Process Parameters 13.

Tool Design
Without a properly designed Tool, the Tool output may not match the dimensional requirements of our customer.

Moulding Tool URS – Describes the moulding tools intended use
Design Qualification – The tool maker has met the design requirements for the moulding tool.

Measuring System
Without a robust Measuring System we cannot rely on the metrology dimensional results.

Shrinkage Study (Customer Requirement Only)
Fixturing Qualification/ Gauge R;R
Robust Process Parameters
Without a robust process small variations in the process could lead to non-conforming results
Process Development (PD) – Iterative process the machine settings to be validated are defined, performed during T0 – T2 trials ; prior to beginning validation activities onsite in Nypro. The nominal settings are developed at this stage; these settings are used to run the FAI ; to define the Process Window to be validated during OQ.

In order to achieve a process window producing cosmetically ; dimensionally acceptable components the validation of a narrower process window may be necessary. A process window is defined by applying the tolerances detailed in the table below:
Table SEQ Table * ARABIC 1: Process Parameters and Window
Moulding Validation Requirements ; PhasesIntroduction of a new tool will always require a full validation. A full validation consists of Factory Acceptance testing (FAT), First Article Inspection (FAI), Installation Qualification (IQ), Site Acceptance Testing (SAT), Operational Qualification (OQ) and Performance Qualification (PQ) 14.

Factory Acceptance Testing (Full FAI)
Documented acceptance testing performed at the tool maker’s site prior to shipping the tool to the site of manufacturing. The tool is tested by the tool maker in accordance with approved protocols & specifications to show that the tool is at a point to be installed & tested at the manufacturer’s site.

The FAT includes a First Article Inspection (FAI) which consists of the measurement of all dimensions on the component drawing (usually completed using a CT scanner). A failing FAI may require a tool modification and an abbreviated repeat of the FAI. In the event an FAT is not required due to a tool move, an FAI is performed at SAT.

The FAT Cpk runs consist of 1 x 2hr run at High settings, 1 x 2hr run at Low settings and 1 x 2hr run at Nominal settings. There are 10 sampling intervals during each FAT run and 5 shots are sampled at each interval. Only one shot per interval is measured and the remaining shots are for destructive testing if required. Cosmetic and surface finish inspections are also completed on these shots. The default Cpk acceptance criteria is ?1.67 across the tool.

Installation Qualification
The purpose of the IQ is to provide documented evidence that all key aspects of the process equipment and ancillary systems are installed correctly. It is the baseline installation configuration of the tool being validated.

Toolroom activities are performed during IQ, were the tool is visually verified for damage during transport and that the contents of the tool delivery match the inventory. The tool is stripped down and cleaned and documented. The baseline of the tool layout is documented; cavities, cores, lifters/sliders present in the tool. The tool number and manufacturer are also recorded.

The baseline of the installation status of all ancillary equipment is documented by the process engineer; Injection Moulding Machine (IMM), Hot Runner and Water Temperature Controller, Material Dryer and Robot. The correct installation of the tool in the IMM is verified and the PD has been completed. This facilitates performing an FAI at this stage if required.

Site Acceptance Testing
Documented acceptance testing performed onsite following confirmation that all installation requirements have been met and to ensure that the tool has not been damaged during transport and to show that a tool is working in its operational environment and that it interfaces correctly with other systems ; peripherals.

The SAT Cpk run consists of 1 x 2 hour run and includes a First Off (F/O) and Last Off (L/O). There are 10 shots taken across the 2 hours, 1 shot per 15 minute interval and 2 L/O’s. During the phase a Validation Production Record and Validation Process Settings sheets and screen drops are required to verify that the correct settings were input and used during the run. Cosmetic inspection of each shot should be performed prior to the dimensional metrology and documented on the applicable cosmetic checklist. The process capability must be ?1.67 across the tool or per cavity.

Operational Qualification
Documented evidence that the defined process parameters produces product to the specified limits within any process extremes, according to written & pre-approved specifications. This is performed upon acceptable completion and approval of the IQ_SAT phase. The OQ phase of the validation is where the acceptability of the process window defined during PD is determined.
The OQ Cpk run consists of 1 x 2 hour run at High settings, 1 x 2hr run at Low settings and 1 x 2hr run at Nominal settings. There are 10 sampling intervals during each OQ run and 1 shot is sampled at each 15 minute interval and a F/O and2 L/O’s are required. During this phase a Validation Production Record and Validation Process Settings sheets and screen drops are required for each settings run to verify that the correct settings were input and used during the run. Cosmetic inspection of each shot should be performed prior to the dimensional metrology and documented on the applicable cosmetic checklist. The process capability must be ?1.67 across the tool or per cavity.

Performance Qualification
Documented evidence that the defined process parameters can consistently produce product that meets pre-determined requirements according to written ; pre-approved specifications. Once all the requirements of PQ are met, components moulded during PQ are considered GMP product.
The PQ run consists of 3 x 8 hour runs at nominal settings. The 8 hours begin when the F/O is accepted. There are 11 shots sampled during each run and 1 shot is taken every hour and an extra shot taken at 3, 6 and 8 hours. During this phase a Moulding Production Record and Master Process Settings sheets and screen drops are required. Cosmetic inspection of each shot should be performed prior to the dimensional metrology and documented on the applicable cosmetic checklist. The process capability must be ?1.33 across the tool or per cavity.

Process Validation Report
The Validation Report is a summary of the Validation findings, and should include the following:
Details of exactly what component (part no., drawing no.) was validated and on which cavities of what tool and in which IMM.

Details of the Process Window that was validated, i.e. OQ process window settings – High, Low ; Nominal
Brief summary of the results of each validation phase, including Cpk results where applicable.

Details of where any Validation Exceptions or Non-Conforming Events were recorded during the validation, including a brief description of each.

Conclusion which states that the Tool is validated for GMP manufacture
Include the completed approved Checklists as embedded objects in the report.

Validation Report is then approved internally ; also by the customer. The approved report is kept with the original validation documentation in the document control centre.

A scan of the manually approved report (PDF), as well as the Word copy with the embedded documents is submitted for approval on NWQS.

Injection MouldingInjection moulding is a method utilised in the manufacturing of plastic products. Injection moulding is an uncomplicated process, however there are various steps involved in producing the finished product 15.

Injection Moulding MachineAn injection moulding machine, also known as an injection moulding press, comprises of two primary parts: The injection unit and the clamping unit. Moulds can be secured by injection moulding machines in either a perpendicular or parallel position and either cold or hot runner systems can be chosen for transporting the plastic into the mould cavities, subjected to the size or type of function that is required for the product being manufactured.

There are ranges of moulding machines categorised by the different dynamic usages. These include Mechanical, Hydraulic, Electric and Hybrid.

The injection mould processInjection moulding is a widespread production process utilised to manufacture plastic products. The process includes introducing hot melted plastic into mould cavities which have been designed to shape the plastic into a chosen shape. The plastic is injected into the mould cavities and left to cool for a defined period of time until ejected off the tool.

The process appears rather basic, however there are additional intricate steps incorporated into the process in order for this process to take place. There are six key steps involved, which are Clamping, Injection, Dwelling, Cooling, Opening and Ejection.

Clamping – The clamp unit is comprised of two metal halves; the moving half and the fixed half. The process commences with the mould tool being clamped together under pressure to house the injection and cooling activities.

Injection – The thermoplastic material pellets are melted in the barrel of the machine and under pressure injected into the mould tool via a screw or a ramming system.
Dwelling – As soon as the melted plastic is injected into the mould, extra pressure is applied to ensure all the cavities in the mould are filled, by means of hydraulic or mechanical pressure.

Cooling – The plastic is allowed to cool and solidify in the mould cavities.

Opening – The moving half is split from the fixed half to separate both halves of the mould tool
Ejection – Ejection occurs following opening of the tool, were the plastic component is ejected of the tool by rods, plates or air.

Figure SEQ Figure * ARABIC 7: Injection Moulding Machine 17Lean Six Sigma Tools for Problem SolvingIn order to frame the problem statement and begin drafting the improvement plan, there are three questions one can ask to provide an initial framework for the overall improvement process and will ultimately link into the concluding improvement plan 16.

What are we trying to achieve?
How will we identify the change is an improvement?
What adjustments can we construct that will result in an improvement?
The DMAIC approach can be used as the model guide for the general project management life cycle. Within each phase of the DMAIC, the PDCA methodology can be applied to achieve rapid actions that will then result in maintainable improvements. In each stage of the PDCA cycle, a range of process improvement tools can be utilised in order to obtain a desired result 18.

Figure SEQ Figure * ARABIC 8: PDCA ; DMAIC 18PDCA CycleThe PDCA cycle (Figure 9) or also known as the Deming Cycle, is a continuous improvement approach containing a systematic series of steps. The cycle consists of four steps, Plan, Do, Check and Act. It is a continuous quality improvement tool that can aid in the work being completed during each phase of the DMAIC, by utilising reduced consecutive cycles of improvement within each step 19.

Figure SEQ Figure * ARABIC 9: PDCA 19The DMAIC Model
The DMAIC model is utilised for improvement, optimisation and stabilisation of a process. The DMAIC improvement methodology consists of five phases, Define, Measure, Analyse, Improve and Control. This is a data driven improvement process road map and is one of the fundamental lean Six Sigma project tools 20.

Figure SEQ Figure * ARABIC 10: DMAICDefineThe purpose of the “Define” Phase is to identify the problem statement, define the objectives, goals and benefits. Identify the team and define resources. The scope and the timeline of the project is included also in this phase, along with business and customer improvement opportunities 20.

Project Charter
The project Charter is utilised to define the project scope, problem statement, objectives, financial justification and the required resources and team members for the project. The project charter is the basis of the project; the purpose and objectives for all team members involved in order to achieve the shared goal 21.

The project charter should consist of a clear, measureable problem statement and how it is aligned with corporate strategic goals. It also includes the start and end dates of the project, team members, project sponsors, scope, key potential deliverables and metrics. The expected project deliverables are also assessed against the time period it will take to implement the project and determines if the project is worth the work and resources that will be involved for the length of the project 21.

SIPOC
The SIPOC (Supplier, Input, Process, Output, and Customer) diagram is a tool used by Six Sigma process improvement teams to identify all relevant elements (suppliers, inputs, process, outputs, customers) of a process improvement project before work begins. This diagram aids in identifying clearly the actual process outputs and the end customer for these outputs. It can provide people who are unfamiliar with a process a high level overview of the key process areas 22.

Supplier – Internal or External suppliers to the process inputs (Eg. Materials)
Input – Inputs to the process to produce the outputs (Eg. Injection Moulding Tool)
Process – Process flow demonstrating the entire process from start to finish and defines the actions on how the inputs are converted to outputs.
Output – Outputs for the internal or external customer (Eg. Payment)
Customer – Internal or External customer of the process receiving the output (Eg. End User)

Figure SEQ Figure * ARABIC 11: SIPOC Diagram 23Team Building
Team building model for team development is forming, storming, norming and performing. This methodology for group development was introduced by Bruce Tuckman in 1965 24. All teams comprise of groups of individuals, however not all groups of individuals have the coherence of a team 25. Tuckman outlined these four phases as necessary for any team to undergo as a means to improved performance, in order to decipher challenges and problems, propose actions, implement the actions and deliver results. The understanding of this approach can assist a project team develop more effectively 25.

Forming – Team members meet and learn of the project. They are positive and polite during this phase. Some members are anxious as the process is not fully understood and the work they will undertake. Other members are enthusiastic with regards to the task ahead 26.

Storming – Team member’s begin forming opinions of one another. Members begin voicing their opinions and disagreements can arise as personalities clash. Patience and persistence is required during this phase to reduce any disruptiveness to the project. This phase is where many teams fail 26.
Norming – Team members begin to co-operate with one another and resolve their differences. They begin to work toward the project goal as a team and are patient toward other team members 26.

Performing – This is the final stage, where the team should be inspired and working together proficiently to achieve the project goals 26.

Figure SEQ Figure * ARABIC 12: Team Building 27The RACI Chart
The RACI (Responsible, Accountable, Consulted, and Informed) Chart is communication plan that is used to define the roles or involvement of people within the company for completing tasks for a specified project or process. It is used for instructing roles and responsibilities inside a team or process, particularly in cross-functional teams or processes that include people from different departments 28.

Responsible – Responsible for doing the actual work
Accountable – Accountable for the completion of the work
Consulted – Consulted for input as required (subject matter expert)
Informed – Informed on progress of task completion

Figure SEQ Figure * ARABIC 13: RACI Chart 28MeasureIn the “Measure” Phase, the process is reviewed, understood and measured to determine the current performance and establish the baseline for improvement 20.

Process Mapping
Process mapping is one of the most operative improvement tools in lean six sigma production and process management. Mapping a process identifies each step in a process and aids in the selection of measures and where and how to identify gaps between the strategic and the actual process. Supplier inputs, process inputs, customers and process outputs can be identified to assist with the evaluation. Process mapping also assists in envisioning the process and supports with value analysis and ultimately determines the delays in lead time when accompanied with baseline data 29.

Figure SEQ Figure * ARABIC 14: Process Map 30Data Collection
Data collection can be performed in various methods. There can be an approved data collection plan consisting of several metrics or there can be limited fundamental metrics that are charted during the project. In a lean six sigma project, the fundamental objective is to determine the capability and performance of a process by comparing existing data to the actual requirements and evaluating the improvement opportunities.

AnalyseDuring the “Analyse” Phase, the key factors and the process inputs are identified that affect the process outputs. The root cause is analysed and determined in order to implement a process improvement 20.

Pareto Chart
The Pareto Chart is one of the simplest, yet most effective tools for helping to identify which areas of a process need focus and to improve on first. This chart separates issues from trivial ones. The height of the bars on the chart reflects the relative frequency of problems. The pareto principle states that “80% of effects come from 20% of the causes” 30

Figure SEQ Figure * ARABIC 15: Pareto ChartBrainstorming
Brainstorming is a structured technique for producing ideas and solutions. Many ideas can be generated in a short period of time and can enable the creative thinking process within a team. This technique can inspire people within the team to come up with opinions and concepts that can initially appear senseless, but can occasionally be constructed into resourceful answers to problems, while others can produce additional ideas 31.

The 5 Why’s
‘5 Whys’ is the most simple and effective tool to identify the true cause of a problem. The purpose of the ‘5 Whys’ is to go beyond what appears to be obvious causes to search for the underlying reasons for a problem or root cause. Without identifying the root cause, efforts are often spent working on a solution that may or may not address the true cause of the problem 30.
The Affinity Diagram
An Affinity Diagram is an investigative tool used to arrange a large number of ideas into subcategories with shared themes or mutual interactions. This process is often used after a brainstorming activity has been complete 32.

Figure SEQ Figure * ARABIC 16: Affinity DiagramCause and Effect Diagram (Ishikawa Diagram)
The Ishikawa diagram, also known as the cause and effect diagram, is used to identify the cause of a specific problem. This tool provides a simple structure to help your team identify all the potential root causes of a problem, which insures that the team does not overlook a possibly major cause in their analysis. It is an easy to learn tool that involves everyone in problem resolution 30.

Figure SEQ Figure * ARABIC 17: Ishikawa DiagramCauses are usually grouped into major categories to identify these sources of variation. The categories typically include:
Manpower – Anyone involved with the process
Methods – How the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and laws
Machines – Any equipment, computers, tools, etc. required to accomplish the job
Materials – Raw materials, parts, pens, paper, etc. used to produce the final product
Measurements – Data generated from the process that are used to evaluate its quality
Environment – The conditions, such as location, time, temperature, and culture in which the process operate
Improve
The “Improve” Phase is to progress possible improvement actions and to test and implement these actions to improve the process and eliminate the issue 20.

ControlThe final stage is the “Control” Phase, were the improvement actions have been implemented and the future performance is controlled 20.

Control Charts
A control chart is a graphical representation of data used to analyse variation in different processes 20.

Figure SEQ Figure * ARABIC 18: Control ChartControl charts can be used to Measure current performance, Analyse causes of variation, Identify opportunities to reduce variation, Control a stable process And identify occasions when maintenance, tool changes, and adjustments are required
Chapter 4- MethodologyThis chapter will detail the framework used for reducing the Injection Moulding Validation Process Lead Time from start to finish and the tools that were utilised during the different stages of the improvement project as previously described in the chapter 3.

Current State AnalysisThe current state analysis focuses on the case organisation and assessing the current state of the injection moulding process and the industry problem.

Case OrganisationThis project was done as part of an improvement project for a leading manufacturer in High Precision Injection Moulding Company (Nypro) that design, develop and manufacture drug delivery systems for healthcare and pharmaceutical companies worldwide.

Problem Statement ; GoalsThe purpose of this project is to improve the Injection Moulding Validation process within Nypro by removing non-value add activities and reducing the lead time from 3-6 months to 5 weeks which in turn will reduce the cost to complete a validation. This project was aligned with the site wide goals and targets.

Measurement ; Data CollectionPrevious Process Validation Reports (PVR’s) were used to assess the baseline performance of the validation process. A period of 2 years previous to the launch of this project was chosen to use as the baseline performance. The measurement interval was evaluated to be sufficient in order to take into account any variation and to define reliability of the baseline performance. A 4 month period after the project was implemented was used to assess the improvements that were made. The 4 month period was deemed sufficient due to the volume of validation required. This assessment provided the project team a comparison to the baseline performance defined earlier in the project.

The 2 year average for moulding process validation was measured and the overall lead time and business impact in euros calculated.

As previously stated, improving the moulding validation process lead time was aligned with the site wide goals and targets for Nypro for reducing lead time, providing clearer RACI and accountability, increased autonomy for process engineers with elements of the process to complete and clearer deliverables from process engineers through to quality.

Three questions were used in order to produce the project charter and formalise the improvement plan
What are we trying to achieve?
Reduce the lead time for the Injection Moulding Validation Process from 3-6 months to 5 weeks by removing non-value add activities which in turn will reduce the time taken to complete a validation and will also result in cost savings for the company.
How will we identify the change is an improvement?
The baseline performance must be identified in order to measure whether the changes implemented have improved the process. The assessment between the baselines performances, compared to the data collected after the improvements were made will identify the changes as an improvement.

What adjustments can we construct that will result in an improvement?
When the project team was defined and the project charter completed (See appendix A), work began following a 10 step PDCA improvement strategy (See table 2)
Table SEQ Table * ARABIC 2: 10 Step PDCA Improvement StrategiesPDCACycle Plan Do Check & Act
1. Define Project Objectives, Scope, Team, Goals & Metrics 3. Map Process Flowchart 5. Identify key performance areas & Root cause Analysis 7. Implementation Plan 9.Analayse Results
2. Define Current State 4.Baseline Data Collection 6. Evaluate potential Improvement Actions 8. Execute Improvements 10.Monitor & Trend Improvements
 
Tools Define Measure Analyse Improve Control
Team Building Baseline Process Flowchart 5 Why’s Summary of Improvements Control Chart
RACI Baseline Data Collection Brainstorming Process with Improvements Volume ; Trend Analysis
SIPOC Affinity Diagram Project Value Summary Table
Fishbone Diagram   Control Phase Activities
Team BuildingThe primary project team was established by the Project Leader (Michelle Martin). The project team consisted of personnel that are involved actively with the Injection Moulding Validation Process. The process owners SB and DO’L were involved at the beginning of the project during initiation and the remaining stakeholders were involved throughout the project to assist and support the improvement project (All Team members can be seen in the project chart in Appendix A). The project began with an opening meeting organised by the project leader to discuss the goals and objectives of the project. The team requirements were defined, along with the key stake holders that would be required to be involved. Brainstorming meetings were organised with the process owner and the internal customers (RF Program Manager) of this process for feedback and improvement thoughts.

RACI (Responsibility, Accountability, and Consulted & Informed) and Team building activities were completed, reflecting Tuckmans’s Model for the different phases of Forming, Storming, Norming and Performing. Following the formation of the team, a RACI chart was developed to help define clear roles and responsibilities and a communication route for each team member.

Figure SEQ Figure * ARABIC 19: Team RACIIn order to understand the Moulding Tool Validation Process, all steps were required to be defined. The SIPOC (Supplier, Input, Process, Output, and Customer) diagram was used to assess and examine the current process steps into a more efficient flow.

The steps involved in Moulding Tool Validation are illustrated below:

Figure SEQ Figure * ARABIC 20: Validation Process SIPOCDefining the BaselineThe baseline process was defined as per the previous Moulding Tool Validations available on NWQS and the focus was placed on the steps in the process involved with the moulding tool been on site in Nypro. These steps corresponded with some of the steps identified in the SIPOC diagram.

Figure SEQ Figure * ARABIC 21: Defining the Process BaselineThe Moulding Tool Validation lead time baseline average was measured using 2 years of previous validation data. Key areas within the validation process were identified as being; FAI, IQ_SAT, OQ ; PQ.
From the data gathered above, a Pareto chart was generated in order to identify the key areas within the validation activities that contribute to the current lead time of 117 Days.

Figure SEQ Figure * ARABIC 22: Pareto of Validation PhasesThe business impact in Euros was also calculated. It is estimated that a validation from the FAI stage through to PQ stage costs €90k.

Table SEQ Table * ARABIC 3: Validation CostValidation Phase Cost In Euros (€)
FAI €17K
SAT €15K
OQ €15K
PQ €15K
Total €62K
Labour Cost In Euros (€)
Per Day €239
Total €28K
Total Cost €90K
The cost for each of the validation phases (€62K in total) is received from the customer as soon as each phase is fully complete and approved. However, Nypro does not see this revenue until 117 days (approximately 6 months) later. The additional €28k is cost of labour for 117 days.

As these validation activities are quite similar process wise, each phase was looked at in detail and a process map developed in order to understand each step and key areas within each step that could potentially increase the process lead time and contain non-value add activities.

See appendix B for process Map. The process map has been broken down into 5 sections as the process is quite large.

Preparing the Improvement PlanBrainstorming meetings were organised following the development of the process flow chart, with the team and key stakeholders. The flow chart was analysed and the 5 why’s also used to collect good ideas for possible root causes on why the moulding validation lead time is so long.
Table SEQ Table * ARABIC 4: 5 why Question to beginRoot Cause Analysis: 5 WhysQuestion: Why the Current Injection Moulding Lead Time is 117 days (Ranges 3-6 months)?
The thoughts and ideas established during the brainstorming session and the use of the 5 why’s were categorised and merged into an affinity diagram and later detailed in a fishbone diagram. The 5 categories that were determined as possible root causes were Methods, Measures, Machine, People and Material.

Figure SEQ Figure * ARABIC 23: Categorised Affinity Diagram following BrainstormingThe results of the activities completed previously; Pareto Analysis, Flow Chart, brainstorming, 5 whys and affinity diagram were combined into a final fishbone diagram. The fishbone diagram demonstrated the most beneficial tool in this project for determining the causes behind the lengthy lead time for the injection moulding validation process.

Figure SEQ Figure * ARABIC 24: Ishikawa Diagram for Process ValidationBelow are the main contributing factors that were identified. Some factors were combined as they are dependent on one another.

Checklist Pre-Approval
Completion of Checklist
Validation Production Record
Predysis, Cpk Analysis ; Reporting
Generic Setting Sheets ; FAI,SAT and OQ Setting Sheets
Attachments
Resources, Capacity and Autonomy
Checklist Pre-ApprovalAll three checklists (IQ_SAT, OQ ; PQ) require the following information in order to pre-approve them prior to beginning the validation activities.

Table SEQ Table * ARABIC 5: Checklist Pre-Requisite Information
Items 2-6 ; 12 are referenced in the approved QPM and items 10-11 ; 13-14 are referenced in the Sampling Plan – Appendix. Recording this information adds no value to the process, as it is already available in the relevant documentation also referenced in the pre-requisite information table. Any document references are approved on NWQS and all Nypro personnel have access
Following the completion of the pre-requisite information each checklist must be approved by the following personnel; Author, Process Engineer, Quality Engineer ; Validation Engineer.

Completion of ChecklistFollowing the checklist pre-approval and validation activities, each individual checklist must be completed. At present the IQ_SAT checklist has approximately 301 entries that must be filled in, the OQ checklist has approximately 151 entries and the PQ checklist has approximately 127 entries. Each checklist must be completed by hand by recording the actual result, whether it was a pass or fail and each entry must be initialled and dated.

Further review of each individual checklist presented duplication of work, adding non-value added activities to the process. Below is the list of activities that at present are recorded in the checklist and in another document related to stage of the process:
Table SEQ Table * ARABIC 6: Checklist Non-Value Added ActivitiesChecklist Other Relevant Document
Resin and Master Batch Type Validation Production Record ; QPM
Resin and Master Batch Batch Number Validation Production Record
Component Drawing Validation Production Record ; QPM
Runs Sampling Plan Appendix
Sampling Plan Sampling Plan Appendix
Cpk Acceptance Criteria Sampling Plan Appendix
Labelling QPM
Validation Production RecordThe information recorded in the validation production record is also included in the checklist or another relevant document to the validation process (See table below). Once more adding non-value added activities to the process.
Table SEQ Table * ARABIC 7: Validation Production Record Non-Value Added ActivitiesValidation Production Record Other Relevant Document
Product Name QPM ; Checklist
Part Number QPM ; Checklist
QPM Checklist
Tool # QPM, Checklist ; Setting Sheet
Machine # Setting Sheet
Resin and Master Batch Type QPM ; Checklist
Resin and Master Batch Batch Number Checklist
Cosmetic Inspection Checklist
Cycle Time Setting Sheet
Number of shots to be taken Sampling Plan Appendix
Predysis, Cpk Analysis ; ReportingPredysis is currently only set up to gather data from the measurement systems. The system delivers a selection of reports for the analysis of data, but these reports are not at present used. Predysis has the ability of performing capability (cpk) analysis on the data that is gathered and can also generate a report.

When performing Cpk analysis that hard copy data must be compiled and manually inputted into minitab. Depending on the component, there could be 2-10 dimensions that are required to be analysed per cavity and moulding tool cavitation can vary from a 1 cavity to 96 cavities. The data must be arranged in minitab as shown below:
Table SEQ Table * ARABIC 8: Minitab Data Arrangement
This activity must be completed for SAT, OQ High, Low ; Nominal and PQ’s 1, 2 & 3. For example if a 16 cavity tool is undergoing validation and the component has 8 dimensions to be analysed, the person completing the Cpk analysis must manually input into minitab a 128 data entries per shot. This equates to 1280 data entries for SAT, 3840 data entries for OQ and 3840 data entries for PQ. This volume of manual data entries can lead to errors, causing further issues when the data is being analysed, it is also a time consuming activity and adds no value to the process when there is an application available to gather this data and assess it.

Upon competition of the Cpk analysis, the Cpk report is generated. The Cpk report consists of a Cpk summary table, and copies of the graphs from minitab. Graphs are generated for each dimension across the tool. See examples below.
Table SEQ Table * ARABIC 9: Cpk Summary Table

Figure SEQ Figure * ARABIC 25: Capability and Probability GraphsIn the event a dimension does not pass across the tool when the cpk analysis is completed, the dimensions must be broken down by cavity. Using the example above if dim-001 does not meet the desired cpk requirement, a cpk analysis must be completed on a per cavity basis. That then results in generating 16 graphs for 1 dimension. See example below.

Figure SEQ Figure * ARABIC 26: Capability and Probability graphs per CavityThis activity also adds no value to the process when there is an application available to generate this type of report.

Generic Setting Sheets & FAI, SAT and OQ Setting SheetsValidation Setting sheets are created for each phase and run of the validation process. The settings sheet template requires the following information to be recorded:

Figure SEQ Figure * ARABIC 27: Process Setting SheetMultiple Screenshots are taken from the machine in order to verify all the settings in the image above. During review the quality engineer must review the each setting and compare them to the screenshots to ensure the correct setting was used.

However the only settings that are validated during the validation process are Injection time, Hold Pressure, Cooling Time, Water Heaters and Hot Runner Controllers. The remaining data recorded does not add value to the process.
In addition to the information required in the validation setting sheets, an identical validation setting sheet is created three times for three different stages of the process. FAI, SAT & OQ nominal are run using identical settings, yet three separate setting sheets are created with screenshots. The parts in each run are moulded identical to one another resulting in the triplication of work using the same settings.

AttachmentsFor each phase of validation there are multiple attachments that are required in order to approve each individual checklist. Some attachments have several parts and each attachment (including the number of parts) needs to be labelled. Below is an example of the attachments that are required for each phase:
Table SEQ Table * ARABIC 10: Checklist Attachments
For IQ_SAT there is approximately 31 attachments that must be labelled, OQ approximately 50 to be labelled and PQ approximately 53 attachments to be labelled.

Each Attachment part, must be stamped with the following and filled in by hand.

Figure SEQ Figure * ARABIC 28: Validation StampThis activity does not add any value to the process and can increase the lead time of a validation by days.

Resources, Capacity and AutonomyResources have a major impact on the completion of a validation. Resources are required for executing the validations, cosmetically inspecting and measuring the parts, analysing the data and completing the checklist. At present the tooling engineer and process engineer are involved in executing the validation, quality inspectors are involved in cosmetically inspecting and measuring the parts and quality engineers are involved in completing the checklist and analysing the data.
However the quality inspectors have their daily tasks to complete along with the additional validation inspections and measurements. Resource capacity and measurement system capacity in the quality labs are limited throughout the day due to production. As well as the quality engineering capacity with their standard work. All paperwork is passed over by the process engineer to the quality engineer as soon as the validation runs are completed and it is then the quality engineer’s responsibility to complete the remaining activities.

Executing ImprovementsKey areas for improvement were identified as part of the analyse phase of this project. Potential changes were discussed with the team and the key stake holders and feedback was received. The feedback was incorporated into the improvement plan. Below are the solutions proposed to improve the current situation:Table SEQ Table * ARABIC 11: Improvement PlanItem Root Cause Solution for Improvement
1. Checklist Pre-Approval Checklist updated to remove Non Value Added activities discussed in the analyse phase.
The number of pre-approvers to be reduced.

2. Completion of Checklist Checklist updated to reduce the number of entries required and to also remove the non-value added activities discussed in the analyse phase.

3. Validation Production Record Validation Production record made Obsolete as required information is recorded in the checklist.
This has reduced the number of attachments required.

4. Predysis, Cpk Analysis ; Reporting Predysis used for analysing and reporting the data.

Cpk report made obsolete as predysis will generate the required information and produce the capability of the process (Cpk), along with a report.

Predysis has reduced the number of attachments required.

5. Generic Setting Sheets ; FAI,SAT and OQ Setting Sheets Validation Setting sheets made obsolete and process settings undergoing validation to be recorded in the checklist. Validation checklists updated to include section to record the settings undergoing validation. This has reduced the number of attachments.

5 shots at FAI will remain the same, SAT ; OQ nom run is no longer required as the same settings are used at FAI.

6. Attachments All unnecessary attachment removed from each phase of validation.

7. Resources, Capacity and Autonomy Quality Inspectors and Measurement Equipment dedicated for Validation activities only.

Validation schedule developed to estimate and plan the work load in the lab with regards to resources and measurement systems.

Validation Checklist updated to increase autonomy for process engineers to complete additional sections in the document.

ControlAt the concluding stage of the project, a control plan was developed as the project was closed and handover executed with the different departments within the company. It was decided that the improvement actions would carry on as per the improvement plan established in section 4.5 for the validation process after the closure of the project to ensure continuous improvement.

The actual control phase activities were project approval by top management and handover to the process owners. The project Team lead (Michelle Martin) circulated all documentation with respect to the project and in addition created and continued communication activities about the improved Injection Moulding Validation Process. A training plan and further observing actions were requested to be carried out in order to sustain the improvements.

A control chart for each validation phase was used to measure the improvements made. Since the implementation of the improvements, 12 Injection Moulding Validations have been executed between December 2017 and March 2018. Each point on the control chart represents the time taken to complete the phase for each individual validation. The control charts can be seen in appendix G. After the changes were implemented the upper control limits and lower control limits narrowed which means that the process has less variation and is more stable. There was also a significant shift in the mean between that also indicates the process has improved.

Chapter 5- Results and AnalysisResultsThe purpose of this project was to reduce the Injection Moulding Validation Lead time from 3-6 months (average 117 days) to 5 weeks (25 days) and reduce the non-value added activities by 90%-95%. Granted that the project was optimistic and it was known that changes would take some time to take effect, the injection moulding validation lead time improved and the time taken to complete a validation was reduced to an average of 30.5 days within a 4 month period in comparison to the baseline data collected previously in the project.

Figure SEQ Figure * ARABIC 29: Validation Activities Average Days Prior Vs. Post ImprovementChecklists (IQ_SAT, OQ ; PQ) were updated to remove the non-value added activities for the pre-approval process; the pre-requisite information was reduced from 14 to 5 items. (See appendix C)
The number of approvers was also reduced from 4 to 2 . The Author and Quality or Validation Engineer are only required for pre-approval. The Sampling plan attachment has been appended to the checklist as part of the pre-approval, as it is required during the validation activities. The average days for checklist pre-approval can be seen below.

Figure SEQ Figure * ARABIC 30: Checklist Pre-Approval Average Days Prior Vs. Post ImprovementEach individual validation checklist was updated to reduce the number of entries required, the IQ_SAT checklist is now only an IQ checklist (reference improvement item 5) and the number of entries was reduced by 62%. The OQ entries were reduced by 64% and the PQ entries 69%. The checklists were also updated to include a section to record the settings undergoing validation. The validation production record was made obsolete as the all acquired information is recorded in the validation checklist or QPM. The average days for checklist completion can be seen below. In addition to the updates to the checklist to remove non-value added entries, the checklists were updated in order to create increased accountability and autonomy for the process engineers with elements to complete. A process engineer can now complete the entire checklist, including the sections that were previously filled out by quality as they are not specific to one role.

Figure SEQ Figure * ARABIC 31: Checklist Completion Average Days Prior Vs. Post ImprovementPredysis data analysis has replaced the need to manually input data into minitab to analyse and assess the capability (cpk) of the tool and it has also replaced the generation of a Cpk report, as the predysis report has all required information present (See appendix D). The average days Cpk analysis and reporting can be seen below.

Figure SEQ Figure * ARABIC 32: Predysis, Cpk Analysis ; Reporting Average Days Prior Vs. Post ImprovementBy implementing improvement items 3, 4 ; 5 it has aided with the number attachments that were required for each of the checklists. The attachment requirement was reduced significantly for all 3 phases. The IQ attachment requirement was reduced to 7, OQ to 9 and PQ to 10. See appendix E. The average days for gathering and labelling attachments can be seen below.

Figure SEQ Figure * ARABIC 33: Attachments Average Days Prior Vs. Post ImprovementDedicated Quality inspectors on each shift were assigned in order to complete any validation activities; this had no impact on production as there are 2 quality inspectors on each shift along with a 3rd if required. Dedicated measurement system could not be allocated due to cost restraints and space within in the lab. However the validation schedule improved the measurement system capacity as the work load could be planned around the measurement systems and production. The validation schedule can be seen in appendix F. The average days the completion of metrology can be seen below. The schedule also increased autonomy for the quality inspectors as they are aware of what needs to be completed outside of production.

Figure SEQ Figure * ARABIC 34: Average Days to complete Metrology Prior Vs. Post ImprovementAs a result of this project the Validation lead time was reduced from 117 days to 35.5 days which is a reduction of 81.5 days and in turn the labour cost to complete a validation was reduced from €28k to €8.5k which is a cost saving of €19.5k for Nypro per validation.

Table SEQ Table * ARABIC 12: Cost SavingsValidation Phase Prior Improvement (117 Days) Post Improvement (35.5 Days)
Cost In Euros (€) Cost In Euros (€)
FAI €17K €17K
SAT €15K €15K
OQ €15K €15K
PQ €15K €15K
Total €62K €62K
Labour Cost In Euros (€) Per Day €239 €239
Total €28K €8.5k
Total Cost €90K €70.5k
Chapter 6 DiscussionDiscussion and ResultsThe Lean Six Sigma approach and methodology provided a great framework for the improvement project, along with the tools used throughout each stage of the project. The Lean philosophy is about enabling continuous improvement and increasing customer satisfaction, whether internal or external. The philosophy is also about creating a process as waste free as conceivable. Six Sigma delivered the tools for measurement and data based decision making. This aided in understanding the process, identifying areas for improvement and bringing the process under control to reduce variation, which in turn reduced the lead time of the process to 35.5 days and the labour cost to complete a validation to €8.5k. The Lean Sis Sigma approach could be applied to other projects or business areas within Nypro.

The PDCA and DMAIC models provided an excellent framework that was structured and easy to follow. There is an abundance of potential in applying the lean six sigma approach and tools for problem solving throughout Nypro, whether it is improving productivity and efficiency, manufacturing, logistics, service delivery or another process. The lean six sigma approach is widespread in the sense that it can be applied to many areas of the organisation.

In order to improve a process or service, there must be measurable data and without the data, improving cannot begin. The process or service needs to be understood before being able to standardise it and improve it. Relevant stake holders need to be brought together in order to align the team under one common and strategic goal.
The lean six sigma approaches and problem solving tools were very useful for establishing a clear baseline, collecting and analysing the data, identifying potential root causes to the issue, offering solutions and implementing changes in a sustainable way. By utilising the Lean Six sigma approach the objectives to improve and reduce the Injection Moulding Validation Process Lead Time from 3-6 months to 5 weeks and lower the non-value activities by 90-95% and in succession reduce the cost to complete a validation was successful. The lead time for the validation process was reduced to an average of 35.5, which resulted in a cost savings of €19.5k.

Issues EncounteredHowever, the project did encounter issues along the way. It was difficult to organise periods of time with all project team members to complete team based activities. Due to this a lot of the work was taken upon me to complete and feedback to the team. This project was required within an extremely short time period of 3 weeks; therefore it was not feasible to delay the project due to the unavailability of team members.

Other issues met involved, the approval of the updated documents through NWQS. Subject to the document type, the approval list involved 4 to 8 approvers. As a result of being the Project Team lead and my availability, all documents were updated by me and submitted to NWQS. During the approval process there were issues observed within some documents and had to be rejected, revised and re-submitted. The approval process takes some time if there are issues identified and the dependant on the availability of the approvers.

Training was rolled out, as soon as the documents were approved. Classroom training and read and understand training was required on the newly revised documents. As there are multiple validations ongoing within the company, there was great difficulty in providing classroom training to the process engineers due to their busy schedules.
Recommendations ; Further OpportunitiesIn order to maintain the reduction in lead time, the author recommends that Nypro should continue with monitoring and controlling the improvement activities and focusing on communication and training with regards to the Injection Moulding Validation Process.

Recommendations for further improvement and opportunities include applying the Lean Six Sigma approach and methodology to the Assembly Line Validation Process and Software Systems Validation Process. Both validation processes would have similar lead times and non-value added activities to the injection moulding validation due to their complexity. This opportunity for improvement will reduce the lead time, non-value added activities and labour cost of the process and will also expedite the manufacturing and delivery of the end product to the customer.

In addition to the above recommendation, if a project is to be implemented an executed within a very short period of time, the project should be conducted off site in order for each team member to provide their full attention and aid in the implementation and execution.

Further development opportunities rest with added exploration into the different features of Lean Six Sigma to discover the most appropriate applications for everyday business use.

ConclusionIn conclusion, this project accomplished its aims and objectives to reduce the lead time of the Injection Moulding validation Process and in series reduced the cost to complete a validation. This project was aligned with the corporate strategic goals and successful.

Chapter 7-References1 Hassanzadeh Rad, M. (2008). Lead Time Reduction Case study:BEAB etikett ; system AB. Högskolan i Borås/Ingenjörshögskolan (IH).

2 Gaither, Norman: “Production and Operations Management”, sixth edition, The Dryden Press, Orlando, 1994
3 Jabil.com. (2018). Nypro. online Available at: https://www.jabil.com/solutions/by-brand/nypro.html4 Jabil.com. (2018). Location in Bray, Ireland. online Available at: https://www.jabil.com/contact/locations/bray.html5 Nypro Site Manager (2018) Welcome Nypro Bray. Internal Nypro Presentation. Unpublished
6 Nypro Site Quality Manager (2017) Nypro Ireland Quality Manual. Internal Nypro Quality Manual. Unpublished
7 Nypro Site Quality Manager (2017) Quality Systems Overview. Internal Nypro Procedure. Unpublished
8 Predisys, Statistical Process Control | Analytics | Quality Control. SPC Software | SPC Process Control | Quality Control System Software – Predisys. Available at: http://www.predisys.com/ 9 Goleansixsigma.com. (2018). What is Lean Six Sigma? – GoLeanSixSigma.com. online Available at: https://goleansixsigma.com/what-is-lean-six-sigma/10 Isixsigma.com. (2018). Little’s Law | iSixSigma. online Available at: https://www.isixsigma.com/dictionary/littles-law/
11 Jabil Lean Council (2015) LSS-400 | Creating Velocity-Overview of Velocity and Flow Management. Internal Jabil Lean Six-Sigma Education Presentation. Unpublished
12 Isixsigma.com. (2018). Little’s Law | iSixSigma. online Available at: https://www.isixsigma.com/dictionary/littles-law/13 Validation Manager (2016) Nypro Ireland Introduction to Validation Module 1. Internal Nypro Ireland Presentation. Unpublished
14 Validation Manager (2016) Nypro Ireland Injection Moulding Process Validation Module 2a. Internal Nypro Ireland Presentation. Unpublished
15 Automatic Plastics. (2018). Understanding the injection moulding process. online Available at: http://www.automaticplastics.com/understanding-the-injection-moulding-process/ 16 Harvard Business Review. (2018). Are You Solving the Right Problem?. online Available at: https://hbr.org/2012/09/are-you-solving-the-right-problem17 Sites.google.com. (2018). Working Principle, Structure and different types of Plastic Molding Machines – China Injection Molding Machine. online Available at: https://sites.google.com/site/dakumarmachinery/home/working-principle-structure-and-different-types-of-plastic-molding-machines18 Jabil (2018) Lean Six Sigma, Internal Online Website Available at: https://www.jabil.com/capabilities/lean-six-sigma.html19 Asq.org. (2018). Plan-Do-Check-Act Cycle (PDCA Cycle) – ASQ. online Available at: http://asq.org/learn-about-quality/project-planning-tools/overview/pdca-cycle.html20} Isixsigma.com. (2018). Six Sigma DMAIC Roadmap. online Available at: https://www.isixsigma.com/new-to-six-sigma/dmaic/six-sigma-dmaic-roadmap/21 Google.co.uk. (2018). six sigma project charter – Google Search. online Available at: https://www.google.co.uk/search?ei=aMR5WoXCDMrz5gLu5J-QAQ;q=six+sigma+project+charter;oq=six+sigma+project+charter;gs_l=psy-ab.3…16252.17955.0.18090.10.10.0.0.0.0.350.1307.0j2j1j2.5.0….0…1c.1.64.psy-ab..9.1.190…0i7i30k1j0i13k1.0.sM4NjRJ2C4E22 Isixsigma.com. (2018). SIPOC Diagram. online Available at: https://www.isixsigma.com/tools-templates/sipoc-copis/sipoc-diagram23 Edrawsoft.com. (2018). Draw SIPOC Diagram from Swimlane Chart. online Available at: https://www.edrawsoft.com/sipoc-swimlane.php24 Anon, (2018). online Available at: https://project-management.com/the-five-stages-of-project-team-development25 Isixsigma.com. (2018). Success in the Development Stages of Six Sigma Teams. online Available at: https://www.isixsigma.com/implementation/teams/success-development-stages-six-sigma-teams/26 Mindtools.com. (2018). Forming, Storming, Norming, and Performing: Understanding the Stages of Team Formation. online Available at: https://www.mindtools.com/pages/article/newLDR_86.htm27 The Coaching Tools Company. (2018). Tuckman’s Team & Group Development Model: What You Need To Know To Get Your New Group or Team Performing Beautifully!. online Available at: https://www.thecoachingtoolscompany.com/get-your-team-performing-beautifully-with-this-powerful-group-development-model/28 Edrawsoft.com. (2018). RACI Model in Six Sigma. online Available at: https://www.edrawsoft.com/raci-sixsigma.php29 Isixsigma.com. (2018). Practical Guide to Creating Better Looking Process Maps. online Available at: https://www.isixsigma.com/tools-templates/process-mapping/practical-guide-creating-better-looking-process-maps30 Jabil Lean Council (2013) Bronze Certification WorkBook. Internal Jabil Lean Six-Sigma Education Presentation. Unpublished
31Anon, (2018). online Available at: https://www.mindtools.com/brainstm.html32 Anon, Affinity Diagram. ASQ. Available at: http://asq.org/learn-about-quality/idea-creation-tools/overview/affinity.html

AppendicesAppendix A

Appendix BAppendix B.1 Installation Qualification
Appendix B.2 First Article Inspection
Appendix B.3 Site Acceptance Testing
Appendix B.4 Operational Qualification
Appendix B.5 Performance Qualification
Appendix C

Appendix D
Appendix E

Appendix F

Appendix GBefore Improvement

After Improvement

Before Improvement

After Improvement

Before Improvement

After Improvement

Before Improvement

After Improvement