Sunday, 5 February 2017

Reduction of Rejected Components & Process Optimiazation of the Subassembly Line & Blister Pack Assembly Line


Introduction & Product Background

This project will focus on reject reduction, optimization and improving efficiency of the Subassembly & Blister Pack Assembly Line. Current reject rates are at 12% and if successful 50% to be decreased in scrap without increasing budget. Total project saving expected of €11.400 per year and cost of increase of production yield to be determined.
Eight different components are used across four stations on the Subassembly Line and the Blister Pack Assembly Line to form the final packaged product. The assembly process include a welding station, 100% online automated test machine, manual assembly, packaging and printing.

Define Phase

The aim of the define phase is to determinate what are the rejects and the efficiency level of the assembly lines by reviewing historical data. My project is in the area which I complete daily quality tasks as a part of routine production. Overall the define phase was more time consuming and challenging then I expected.
To begin with I organized a meeting (department of quality, engineering and production member) where we clearly set the project structure and project plan. After the meeting I was able to create Project Charter, reference in Figure 1 below.

Figure 1 Project Charter



Next, I mapped the process and create the process flow - SIPOC Diagram to ensure I understood the core process and all different stages of the assembly lines, reference in Figure 2 below.




                                                                           Figure 2 SIPOC Diagram


To identify the most common rejects and its location on the line, I collected data from six shop orders manufactured during four months and created Reason for Failure Check Sheet, reference in Figure 3 below. 


                                                                       Figure 3 Reason for Failure Check Sheet


Based on information gather from the data listed in Figure 3, I created Pareto Chart (reference in Figure 4 below), which conform to some extent 80/20 principle. Base on this principle the top three reject accumulated to 74.9% of a total failures. The test machine is the most frequent reason for failure with 777 rejects found (31.7%). The Pareto Chart was very useful tool to show what areas are to be targeted as a part of the project reject reduction.


Figure 4 Pareto Chart


To show the efficiency of the production lines I calculated the Performance Rate from the formula below.

I collected data from six shop orders manufactured during four months and calculated performance rate at 101% (Project Proposal). Since the project started all the data was reviewed in more detail and indicate that the Ideal Cycle Time is set incorrectly as new performance rate was at 108, refer to Figure 5 below.  This was the most time consuming and complicated part of the define phase. The issue with the too high performance rate required two long meetings with project team and reviewing data back from the validation stage. Revised Cycle Time was increased due to additional inspection points added to the line since validation.

Figure 5 Performance Rate Check Sheet



Finally base on the information gathered during the Define Phase I created a project plan – Gantt Chart to help me visualize the project tasks and management timeliness, reference in Figure 6 below.

                                                                                       Figure 6 Gantt Chart


Measure Phase 

The Measure Phase includes the following sections:
  1. Section 1 - Scope
  2. Section 2 – CTQ Tree, Process Mapping & Data Collection Plan – Operational Definitions
  3. Section 3 – Rejects Reduction ( 100% Online Test Machine, Welder, Gate Stringing)
  4. Section 4 – Cycle Time and Performance Rate
  5. Section 5 - Gantt Chart update


Section 1 - Scope

The Measure Phase was more in depth than expected before I started the work. During this phase I have learned a lot about the assembly & test process from an engineering point of view.

Base on the information gathered in the Define Phase it was decided to concentrate on the three areas of reject reduction: 
  • 100% Online Test Machine
  • Welder
  • Visual Issue - Gate Stringing

To gain an understanding on why the current process in each of the three areas is causing rejects a number of data sets were collected, samples tested and studies completed.


Also, reviews of the Performance Rate inputs were completed as a part of improving efficiency & optimization of the lines.

Section 2 - CTQ Tree, Process Mapping & Data Collection Plan - Operational Definitions

I started with creating the Critical to Quality (CTQ) Tree to provide clarity around aspects of the Voice of Customer. Refer to Figure 7 below.

Figure 7 CTQ Tree



Post the CTQ step I completed the detail mapping of the real process for the Subassembly & Blister Pack Assembly Line to help bring clarity to complex processes and highlight the Bottle Neck station. Refer to Process Mapping below, Figure 8.

Figure 8 Process Mapping

A Data Collection Plan – Operational Definitions has been created to specify how much data will be collected and how often. Refer to Figure 9 below.

Figure 9 Data Collection Plan - Operational Definitions


Section 3 - Rejects Reduction

Three areas for reject Reduction: 100% Online Test Machine, Welder & Visual Issue – Gate Stringing.

  •  100% Online Test Machine

The measure phase builds upon the existing data available in order to fully understand the historical behavior of the process. This was very important step in the project to establish the baseline in the terms of level of rejects and where the data falls within the control limits.

This was achieved with collecting the data outputs from the Test Machine – Station 2 over five days production.

There are 5 different functional test completed on the Test Machine:   
  1.  Valve Seal Integrity Test - Pressure Decay at Bottom Sealing Ring
  2. .Opening Pressure
  3.  Valve Seal Integrity Test - Pressure Decay at Top Sealing Ring
  4. Air Flow through Bleed Tube
  5.  Air Flow through Syringe Port


From the reject quantities for each individual test I was able to create a Pareto Chart. Refer to Figure 10 below. As we can see from the chart below two tests are contributing to 96.5 % of the rejects.

Figure 10 Pareto Chart – Test Machine


The data from this tests were subjected to normality tests and Process Capability Sixpack using Minitab Version 17 to help visually assess capability of the process,

To understand correlation between the Online Test Machine and the Offline Test Rig a total of 8 days production rejects from the Online Test Machine has been collected and tested on the Offline Test Rig. The results from this tests are displayed on the check sheet below (refer to Figure 11). 56% of the failed rejects from the Online Test Machine failed on the Offline Test Rigs.

Check Sheet for Rejects from the Online Test Machine tested on the Offline Test Rigs
Test Name
Number of samples failed on the Offline Test Rigs
 Pressure Decay at Bottom Sealing Ring
7
 Valve Opening Pressure Test
0
 Pressure Decay at Top Sealing Ring
72
 Air Flow Through the Bleed Tube
1
 Air Flow through the Syringe Port
0
Total Number of samples failed Offline Test Rigs
79
Total Number of Samples Tested
141
End of Table
                                                Figure 11 Check Sheet for Rejects from the Online Test Machine

  • Welder

The ultrasonic welder – Station 1 is a manually operated equipment and is used to weld the Valve Lid to the Housing with a Silicone Disc in between these parts. There are three control outputs on the welder: Weld Energy, Weld Time and distance RPN after holding time (RPN+).

The welder machine was set to record data outputs over 5 days production. From this data, I was able to analyze which outputs are contributing to highest level of rejects. Refer to Pareto Chart below, Figure 12.

Figure 12 Pareto Chart - Welder

A Minitab analysis was performed on the welder output data. An expected overall performance was checked and gave us prediction of the proportions that will fail the specification limits. A graphical summary of the data was generated  and Process Capability Sixpack performed for the three control outputs to help visually assess capability of the process.

All the rejects collected on the welder have been tested on the Online Test Machine and the Offline Test Rig. Refer to Figure 13 for the summary of the results. Only one part has failed both online and offline Valve Seal Integrity Test – Pressure Decay at the Top Sealing Ring. This tells us that 2.3% of the weld rejects are functional failures and give as a scope to work on the for rejects reduction.

Check Sheet for Rejects from the Welder tested on the Online Test
 Machine & Offline Test Rig
Test Name
No. of samples failed on the Online Test Machine
No. of samples failed on the Offline Test Rig
Pressure Decay at Bottom Sealing Ring
0
0
 Valve Opening Pressure Test
0
0
 Pressure Decay at Top Sealing Ring
1
1
 Air Flow Through the Bleed Tube
0
0
 Air Flow through the Syringe Port
0
0
Total Number of samples failed
1
1
Total Number of Samples Tested
43
43
End of Table
                                                                Figure 13 Check Sheet for Rejects from the Welder

  • Visual Issue - Weld Stringing

Weld flash/string is present on the subassembly after welding process (Station 1) but it’s not a visual issue as remains intact against weld joint. It’s become a visual issue when is being pulled up.

A control study – 50 parts were assembled and tested as per usual process. From this study all parts have been inspected to investigate at which step the weld string is being pulled up.  The results are summarised in Table 14 below.

Check Sheet for Weld Stringing Study
Inspection Point
Result
After welding process (Station 1)
No Weld String found
After testing on the Online Test Machine (Station 2)
No Weld String found
After vacuuming the part – prior to use on Manual Assembly (Station 3)
2 parts with Weld String above acceptable limit
End of Table
                                                Figure 14 Check Sheet for Weld Stringing Study


 Section 4 - Cycle Time & Performance Rate

I started with measurement of the Cycle Time during production run over 5 days. Each day I measured time for the 10 final assemblies. The average time (theoretical) for completion of the one unit was 57 seconds and included operators waiting time for parts and minor stoppages (work overload at Station 4 – Bottle Neck Station).

Based on this information I organised a brainstorming session where we revised the all parameters contributing to performance rate calculation. At the end of the session we were all confident that the Operating Time includes non-productive time and this is contributing to the issue with high Performance Rate. We estimated that on the average 14% of the time each day is non-productive on the assembly lines. 


Section 5 - Gantt Chart update

The Gantt Chart was updated to reflect changes made to the project during the Measure Phase, refer to Figure 15.

Figure 15 Gantt Chart




Analase Phase 

The Analyse Phase includes the following sections:
  1. Section 1 – Scope of the Analyse Phase
  2. Section 2 – Rejects Reduction – Welder
  3. Section 3 - Rejects Reduction - Gate Stringing
  4. Section 4 – Poor Productivity Analysis

Section 1

The aim of Analyse Phase was to:
  • gain an in-depth understanding of how the process on the assembly lines really works
  • develop ideas – potential root causes
  • focus on gaining understanding from the data itself
Section 2 

To begin with we completed a Control Study with Open Limits to understand where the outputs are falling when the welder stops once one of the output is not met. The specification limits have been selected by Engineering Leader:
  • RPN+ : lower limit – 0.33mm and upper limit – 0.41mm
  • Energy: lower limit – 43J and upper limit – 66J
  • Time: lower limit – 0.15s and upper limit – 0.25s

A total of 100 parts has been made and data outputs collected. The data from this study were subjected to normality tests and Process Capability Sixpack. All samples have been tested on the Online Test Machine and Offline Test Rigs.

 Summary of the information gathered during the control study with open limits:
  • No welder rejects found with new open limits
  • 8 rejects out of 100 failed the old welder specification limits
  • 3 samples out of 100 failed on the Online Test Machine Test and 2 of them failed on the Offline Test Rigs. These failures are typical of the process rejects on the Online Test Machine and were within the welder parameters


Next we completed the Verification Run based on the information gathered during control study. New specification limits for three outputs have been suggested:
  • RPN+ - 0.33mm - 0.40mm
  • Energy – 45J - 61J
  • Time – 0.15s - 0.22s

A total of 500 parts has been made and data outputs collected. Also, all samples have been tested on the Online Test Machine. A graphical summary of the data and Process Capability Sixpack was generated.  An expected overall performance was checked and gave us prediction of the proportions that will fail the specification limits:
  • RPN + - in this case, the expected performance figures predict that 0.15 % will be below LSL
  • Weld Energy - the expected performance figures predict that 0.97 % will be below LSL
  • Weld Time - the expected performance figures predict that 0% rejects

Summary of the information gathered during verification run with new suggested limits:
  • 1 sample failed during the welding process 
  • 19 samples out of 500 failed on the Online Test Machine. These failures are typical of the process rejects on the Online Test Machine and were within the welder parameters.
  • New limits on the welder suggest 0.20% of reject 

Finally we completed a functional test and checked weld strength - Valve Lid Weld Tensile, specification limit ≤ 200 Newton. 50 samples have been selected randomly and independently from 500 parts made during verification run. 25 samples have been taken with at least one of output at lower end of the specification and another 25 samples with output at higher end of the specification. All samples passed specification limit and confirmed that parts are functionally acceptable. Refer to Box Plot below, Figure 16. 


                                                                     Figure 16 Box Plot - Valve Lid Tensile Test


Section 3 

To begin with the verification run was completed to find out the operators influence for weld string creation. A total of 500 parts were assembled and tested as per usual process. Two operators have been involved with visual inspection of the parts. The results are summarised in Table 17 below.

Check Sheet for Weld String Verification Run – Operator influence
Inspection Point
Operator 1
Operator 2
Number of parts checked
250 parts
250 parts
After testing on the Online Test Machine (Station 2)
5
11
After vacuuming the part – prior to use on Manual Assembly (Station 3)
7
0
End of Table
Figure 17 Check Sheet for Weld String Verification Run – Operator influence

   
Next I organised a meeting with project team to review all weld string rejects collected during operator influence study. The weld string is located on the different areas around weld joint. The size of weld string varies between 0.2 cm – 1 cm. Base on the size of weld string and review of customer acceptance requirements, a limit sample has been signed off to provide more detail instruction during inspection, refer to Figure 18 below. With new limit sample in place, only 10 out of 23 parts would failed during weld string verification run and suggest improvement of over 50%.

Figure 18 Weld String Acceptance Sample



Section 4



I organised the brainstorming session with the project team to identify the potential root causes of the poor productivity / non-productive time on the assembly lines. Base on the information gathered during this session I was able to create the Fishbone Diagram to visually display all potential causes, refer to Figure 19 below.


                                                                                  Figure 19 Fishbone Diagram



Improve Phase 

The Improve Phase includes the following sections:
  1. Section 1 – Scope of the Improve Phase
  2. Section 2 – Pilot Study – Welder & Weld Stringing
  3. Section 3 - pFMEA for the Welder
  4. Section 4 – Control Run - Improvement of the Non-productive Time

Section 1

The aims for the improve phase was to:
  • Generate potential solutions & select the best solutions
  • Asses the risk of implementing the solutions
  • Complete the pilot studies before full implementation

Section 2

Based on the information gathered during Analyse Phase a pilot study was completed on the assembly lines with new outputs on the welder and improvements made for the weld string rejects reduction. This controlled trial confirmed the effectiveness of the proposed changes on the Assembly Lines before full implementation.

To begin with I organised the meeting with project team to plan a pilot study where we clearly set the scope, time frame and data collection plan. Refer to Figure 20 below. 

Pilot Study Plan
Scope and area of the study (Where?)
The scope of the study is to complete controlled trial on the Assembly Lines: Station 1 – First Stage Assembly, Station 2 – 100% Online Test Machine & Station 3 – Manual Assembly Cell.

New welder outputs from the Verification Run will be set up on the welding machine (RPN+ - 0.33mm-0.40mm, Energy – 45J-61J, Time – 0.15s-0.22s).

All parts will be tested on the 100% Online Test Machine.

A visual inspection of the weld string will be completed at each station with new limits sample in place
Time
frame (When?)

A minimum of 8 hours’ shift – 500 part to be made during this study.
Data collection plan (How?)
All parts will be number from 1 to 500.
First parts will be assembled on the manual operated ultrasonic welder, tested in order on the 100% online automated test machine and visually inspected for the weld string.
All good parts and rejects will be collected by Operators and results recorded.
Printout of the outputs from the welder and test machine will be collected by Engineering Leader and review by project team.
End of Table
Figure 20 Pilot Study Plan

After completion of the Pilot Study I organized second meeting with the project team to review all the data collected. After the meeting I was able to summarized the outcome of the study:
  • 7 sample failed during the welding process – this give us 1.4% reject rate
  • 2 samples failed for weld string above the acceptable limit sample – 0.4% reject rate
  • 19 samples out of 500 failed on the Online Test Machine. These failures are typical of the process rejects on the Online Test Machine and were within the welder parameters
On the analysis of this data a significant reduction of rejects was observed for the welder and weld sting. I created reject reduction charts to display improvement made. Refer to Figure 21 below for the Reject Reduction Chart for the Welder which shows a saving of 2.4% from the baseline figure of 3.8%. Refer to Figure 22 below for the Reject Reduction Chart for the Weld Stringing which shows a saving of 0.78% from the baseline figure of  1.18%. 

Figure 21 Reject Reduction Chart - Welder

Figure 22 Reject Reduction Chart - Weld Stringing

Section 3


An pFMEA risk analysis tool was used to evaluate changes made on the welder outputs. Analyses of the process key outputs, potential failures and consideration of the effect of process failure on the product were targeted. Refer to Figure 23 below for analysis up to RPN scoring. I have gained an enormous amount of understanding about the tool and practical experience while working on the completion of this risk analysis.


Figure 23 pFMEA - Welder


Section 4

Based on the information gathered during the previous phases of the project about non-productive time on the assembly lines and its potential causes, I organised the brainstorming session with the project team and production personnel. In order to reduce time wastes at the bottleneck neck station (Station 4) decision was made to remove visual inspection point for the loose particulates/black threads. This additional step was introduced to the line over eight months ago. All quality and production data from the last 8 production lots have been reviewed (First Piece Approvals, In Process Inspection Reports, Attributes Control Charts & Final QC Inspection Reports). There was no issue found during this period with loose particulates/black threads. Based on this information, it was decided to complete control verification study during the next production run before full implementation of the proposed change.

Control Run requirements:
  • Temporary changes to be made to all production work instruction and paperwork to remove inspection for loose particulate/black thread at the end of Station 4
  • Additional QC inspection to be completed during this run for loose particulate/black thread
  • All operators and QC Inspectors to be trained on the required changes
  • Data to be reviewed on the daily basis at the morning meeting by management 


From the data gathered during first four day of the control production run we estimate improvement of non-productive time from 14% to 7%-5%.

Control Phase 



The Control Phase includes the following sections:
  •  Section 1 – Scope of the Control Phase
  • Section 2 – OEE Rate Metric & Stop Even Log
  • Section 3 – Goals summary
  • Section 4 – Lesson Learned and My Contribution
Section 1

The aim of the control phase was to ensure that the improvements that have been implemented become embedded into the process, maintained high quality level and sustained after the project has been closed.

Section 2

To control the rejects level and the performance rate together with availability & quality rate I drafted the template for the OEE Rate metric calculation. Refer to Figure 24 below. I found this metric very informative as overall efficiency of the assembly line will be controled and reviewed  for each lot.
                                                                            Figure 24 OEE Rate Metrics


Also, I created a Stop Event Log (refer to Figure 25) to record all downtime occurred during production in order to get accurate values when calculating the OEE Rate and control non-productive time. 


Figure 25 Stop Even Log 


Section 3

The project has achieved the majority of its goals and proved that the reject reduction & optimization of the assembly lines was possible.


The following were the goal of the project:



1. Overall reject reduction on the Subassembly Line and the Blister Pack Assembly Line from baseline 12% to 6%.

Results:
  • Welder – Proposed changes to the welder outputs show a substantial reject reduction of the 63% from the baseline of 3.8%. 
  • Weld String -  the goal was achieved and 67% of the reject reduction has been made from the baseline of 1.2%.
  • Reducing level of the reject on the welder and minimizing level of the weld string show that overall reject reduction of 5% from the baseline of 12% 
2. Optimization of assembly line by improving process flow between different stations on the lines. 

Results:
  • Process flow on the lines have been improved due to elimination of the time wastes at the bottleneck station.
  • Non-productive time have been reduced by minimum of the 50% and significant increase of the output has been noted from the average of 450 parts being made per shift to minimum of 500 parts.

3. Overall financial saving  after scrap reduction and optimization of the assembly lines - potential annual saving of €11400.

Result: The goal was achieved and potential annual saving of  €11400 .

4. Increase Production Yield

Result: The production yield has increased by 5.7% from a baseline of 88% to 93%.

Section 4

Lesson learned

Using DMAIC approach through the project showed the systematic and informative method of addressing the issues. Far better understanding of the processes, exact rejects causes & use of the data driven quality approach are one of the few things learned during the project. All future projects (e.g. reject reduction on the moulding machines) should be addressed by using DMAIC methodology.

The project was conducted between the Blister Pack Assembly routine production runs which meant that the time for the control studies/verification runs was very limited.  Time constrain for the submission of the project together with limited access to the lines were very difficult to overcome. It is recommended for the future projects to be scheduled at times of the year when production is not running.

The project focused primarily on the reject reduction and optimization of the assembly lines. All other areas were outside the scope. During the analysis of the data outputs from the rejects testes on the 100% Online Test Machine and Offline Test Rigs (measure phase) a new information has been highlighted that the correlation study should be completed between the the test machine and test rigs. This issue is being currently addressed by engineering department.


My role and Contribution
The project was 95% my own work with assistance from the Quality & Training Manager and Engineering Leader. I drove this project through to completion and successfully reduce reject rate and optimized the Assembly Lines.



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