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Posted July 17, 2018

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Quality Improvement Kaizen Event in the Pharmaceutical Sector

PROJECT TITLE:

Quality Improvement Kaizen Event

KEY BUSINESS CHALLENGES AND PROJECT OBJECTIVES:

Our Pharmaceutical client processes batches in a continuous process, with the specifications of one critical feature between 2 and 5%. It was noted that at the start of the 2018 that the product was performing towards the lower specifications. As a result, approximately 50% of the product was reworked. Given the implications of operating at a lower specification, a cross functional Kaizen team was assembled with the following objectives

Increase product average to 3.5% +/- 0.1
Eliminate non-value-added rework activities

CLS APPROACH AND CHANGES IMPLEMENTED:

CLS worked with the Project Team, identifying containment actions that would contain the processing of lower specification product, with the implementation of additional testing.

Next, an SPC analysis of the baseline information was performed, which identified when the process shifted in average. From an analysis of change controls, the root cause of the problem was identified, and actions were implemented to counteract the root cause including changes in pumps, pipework and valves. The Kaizen team walked the process, from tank to tank, and identified other process steps that may have contributed to the problem. 10 Areas were identified and prioritised by the team, which resulted in 4 key projects being identified and agreed by the entire team.

These projects were reviewed monthly and over the course of 4 months, key changes were implemented through the change control process including changes to Product Unit design, modification to the management of flow of product, changes in temperatures and heat exchanger modifications.

As a result of the changes implemented, the additional measurements were reduced, and the process is now monitored on an SPC chart real time.

SPC Real Time Chart

RESULTS / OUTCOMES:

The process average increased from 2.7% to 3.6%, with the SPC chart highlighting no special causes
Reduced variability compared to baseline data
Reduced rework time by 90%
Full engagement of the team ensured an optimal result to a problem that could not be addressed by one person alone. The quality of the final solutions was dependent on the knowledge of the entire value stream which was a critical success factor in the identification of a sustainable solutions.

CONTACT US:

To find out more about using a Kaizen based approach for process improvement, contact maria.ryan@crystalleansolutions.ie

Managing Customer Backlog Through visual Management

KEY BUSINESS CHALLENGES AND PROJECT OBJECTIVES:

Working with an EI client on a LeanPlus project, our multinational client wished to improve the management of Customer Backlog in their busy Support Office.

THE PRIMARY OBJECTIVES OF THE PROJECT WERE:

Provide a means of communicating to all team members the following:
- The latest backlog numbers
- Team/Individual Priorities
- Issues – addressing and escalating if required
Better use & flow of information relevant to the team, who will then act upon the most up to date and accurate data

CLS APPROACH AND CHANGES IMPLEMENTED:

Working with the key stakeholders, we conducted a series of Visual Management workshops to a) identify metrics that were of value to the team b) agree key metrics to track and c) agree communication plan to the full team and the rest of the organisation. The team also completed rapid problem-solving training to address gaps in metrics against target.

Developed daily stand up meeting charters
Designed Backlog Visual board complete with Action Plan
Implemented stand up daily team meetings (Tier 1 Meeting)
Developed an escalation process to Tier 2
Implemented digitisation board
Implemented Process conformation

RESULTS / OUTCOMES:

As a result, all team members are now:

Aware of the total back log number daily
Able to prioritise their work load with greater accuracy than before
Able to highlight issues at morning stand up meetings before issues spiral out of control and use rapid problem solving where applicable
Accountable for delivering on agreed plans
Able to escalate issues that need the assistance from other departments

Since introducing the Visual Management boards a number of records have been broken, including the most call history closed in a single day and hitting a 15% reduction in backlog. The lowest ever total back log number. These milestones were celebrated by the team at the Tiered meeting. This process has also been rolled out in the Europe and US offices.

To find out more about Daily Accountability and Tiered processes, email maria.ryan@crystalleansolutions.ie

On Time Delivery Improvement Project

Key Business Challenges and Project Objectives:

Our Engineering Services client has a functional structure and found it challenging to ship on time, consistently. From an analysis, a number of issues were identified preventing shipments on time. One area identified was a lack of communication across the functions, resulting in shipments not meeting delivery requirements. CLS were invited to mentor the team on Visual Management as a possible improvement to managing shipments. The key objectives of this project were:

Design and implement a Visual Management System to support On Time shipments to customer
Improve On Time Delivery from 60% to 75%

CLS Approach and Changes Implemented:

CLS worked with the Project Team, starting with identification of the customers of the Shipment process and understanding their requirements, using a SIPOC. A list of 65 requirements were identified initially. The 65 items were prioritised and reduced to 8 critical requirements. Next the key information required to meet customer requirements were identified and who can provide this data. The team communicated these requirements to the relevant people and confirmed how frequently the information was required and in what format. On completion on the SIPOC, the following actions were implemented over a two-month timeframe with minimal investment:

Designed a Shipment Board with the key elements of information identified on the Board
Identified colour coding to identify what elements were on target for shipment (green) and what elements were not on target (red)
Designed a process to implement actions for Red items
Completed training and Piloted the process
Updated board design from Pilot

Results / Outcomes:

Designed and Implemented a Visual Management System to manage shipments.
Engaged the functions to work effectively together and reducing stress associated with shipments for people involved.
Improved On Time Delivery from 60% to 80%.

On Time Delivery Improvement Project

Key Business Challenges and Project Objectives:

Our Engineering Services client has a functional structure and found it challenging to ship on time, consistently. From an analysis, a number of issues were identified preventing shipments on time. One area identified was a lack of communication across the functions, resulting in shipments not meeting delivery requirements. CLS were invited to mentor the team on Visual Management as a possible improvement to managing shipments. The key objectives of this project were:

Design and implement a Visual Management System to support On Time shipments to customer
Improve On Time Delivery from 60% to 75%

CLS Approach and Changes Implemented:

CLS worked with the Project Team, starting with identification of the customers of the Shipment process and understanding their requirements, using a SIPOC. A list of 65 requirements were identified initially. The 65 items were prioritised and reduced to 8 critical requirements. Next the key information required to meet customer requirements were identified and who can provide this data. The team communicated these requirements to the relevant people and confirmed how frequently the information was required and in what format. On completion on the SIPOC, the following actions were implemented over a two-month timeframe with minimal investment:

Designed a Shipment Board with the key elements of information identified on the Board
Identified colour coding to identify what elements were on target for shipment (green) and what elements were not on target (red)
Designed a process to implement actions for Red items
Completed training and Piloted the process
Updated board design from Pilot

Results / Outcomes:

Designed and Implemented a Visual Management System to manage shipments.
Engaged the functions to work effectively together and reducing stress associated with shipments for people involved.
Improved On Time Delivery from 60% to 80%.

To complete a Competitive Benchmark Study

Key Business Challenges and Project Objectives:

Working with an IDA client on a LeanPlus project, our multinational client wished to improve the management of the business in a systematic way and build for the future. A Competitive Benchmarking study was proposed with the following objectives:

To define the current competitive position of our client against its competitors
To identify strengths and opportunities within the business
Development of an Action Plan based on the Results

CLS Approach and Changes Implemented:

CLS provided an overview of the Benchmarking Process and the outcome of the Process prior to engaging in the Benchmarking activity. We then selected a cross functional team to work with us to complete a balanced view of the organisation. The key actions implemented to complete the Benchmarking Study included:

Facilitate the cross functional team to answer 52 questions with respect to the business across Finance, Learning and Growth, Internal Processes and Customer Services
Completed the Benchmarking study using PROBE
Developed a Report based on the PROBE Output and reported back to the team
Identified and prioritised areas of improvement and collectively developed a plan to address the top three priorities.

Results / Outcomes:

Identified client strengths against their competitors and the areas for improvement that can enable them to be more competitive
Engaged a cross functional team in the Competitiveness Benchmarking Process
Identified a Lean Action Plan to improve their Internal Processes that will increase their competitiveness.

Design and Implementation of a Problem Solving Culture

Key Business Challenges and Project Objectives:

Over the past 4 years, we have been working with a leading Multinational Medical Devise organisation, who operate in a highly regulated yet cost competitive environment. Our client required to change their culture from Fire Fighting to a Learning Based Problem Solving culture. The objective of this project was to:

Facilitate the development of a Learning based Problem Solving culture

CLS Approach and Changes Implemented:

CLS worked with the Project Leader to first understand the current process for Problem Solving on site. Based on this initial analysis, a new Problem Solving Process was developed and piloted. The two elements of the process included;
a) natural work teams using the A3 Problem Solving process to manage a problem from definition to elimination and
b) Lean Coaches that would support a team through the Problem Solving Process.
On completion of the Pilot, CLS completed the following:

Delivered A3 Problem Solving Process training to approximately 500 employees
Delivered Lean Coach training to 80 employees to support the Problem Solving Teams

Results / Outcomes:

Implemented a Problem Solving Based Culture
Trained nearly 600 employees in the A3 Problem Solving Process
Achieved €500k Cost Savings over a 2-year period

Translating Strategy into Action through Hoshin Planning

Key Business Challenges and Project Objectives:

Our Irish client, a pharmaceutical manufacturer was at a turning point in their business history. A profitable organisation that had succeeded based on a top down approach, now recognised that in order to grow the business by 50% a different approach would be needed. While our client had agreed an initial Vision for the business, they were anxious to translate the Vision into a tangible, executable plan. CLS were asked to deliver this process. The key objectives of this project included to:

Define a Strategy Deployment Process
Translate the Company Strategy into an Action Plan
Deploy the Strategy across the organisation

CLS Approach and Changes Implemented:

Working with the Senior and Middle Management of the organisation, CLS utilised a Hoshin Planning based approach, coupled with Action Based Learning workshops to achieve the project objectives. By working with the Leadership team, over 18 months, the following actions were implemented:

Designed a working Strategy Deployment process, to generate real buy in to the Vision and to develop Strategic Goals that are aligned with that longer term vision
For each Strategic Goal, KPI’s were determined
Annual objectives were created to facilitate achievement of the critical KPI’s
A Balanced Scorecard was developed and utilised to manage strategy execution
A Visual tool was created to communicate the Annual Goals and Objectives to all employees
Aligned the Performance Management Process to the Strategy Deployment Process
Aligned 3 other key Business Processes to the Strategy Process

Results / Outcomes:

Designed and Implemented a Working Strategy Deployment Process from Vision to Execution.
Aligned the organisation to the Company Vison to ensure consistency of Purpose
Engaged the Leadership in active participation in aligning the organisation to the Vision
Developed a Process to monitor and control critical KPI’s.

To design and transfer a New Product Introduction into Operations effectively

Key Business Challenges and Project Objectives:

Our multinational client, a manufacturer of medical devices was introducing a new unique product into the business. To ensure that they were sufficiently resourced to deploy this new product using Six Sigma tools, Crystal Business Solutions were invited to be the statistical resource team member as part of the NPI team. The key objectives of this role, over a 3-month period, included:

To provide statistical support in the design and optimisation of the process

CLS Approach and Changes Implemented:

Using the DMAVD methodology, CLS provided the following statistical support in the introduction of the new product:

Complete 26 Gauge R&R’s to ensure that gauges were capable of measuring critical product features effectively
Designed 8 Iterative Design of Experiments to select optimal process parameters to manufacture product in an operational context
Using Minitab, statistically analysed the results of each Design of Experiment and an input into the next iteration of Design of Experiments
Set up SPC on critical to quality parameters

Results / Outcomes:

Optimised the operational parameters to manufacture a New Product introduced on site
Ensured that the gauges utilised in manufacture were capable of measuring critical features
In conjunction with NPI team, delivered the New Product on time, on budget and within quality specifications

To redesign the Sales Picklist Process to comply with Quality Standard ICH Q7

Key Business Challenges and Project Objectives:

Our multinational client, a manufacturer of bulk Active Pharmaceutical Ingredients, made a strategic decision to migrate to a new electronic system. From their Warehouse perspective, this change would result in the current Sales Picklist Process being out of compliance with Quality Standard ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients. The process also did not fit with the standard process within the new electronic system and customisation was too expensive. Crystal Lean Solutions were invited to lead the Redesign Project in conjunction with the Warehouse team members over a 4-month period. The key objectives of the project included:

To resign the Sales Picklist Process to comply with ICH Q7 and to suit the new electronic system workflow
To Streamline to Sales Picklist Process

CLS Approach and Changes Implemented:

Using the DMAVD methodology, CLS first reviewed the current process with warehouse personnel, mapping the actual workflow and paperwork trail. Key steps under review included a) identifying customer requirements b) selecting appropriate materials c) labelling drums and d) supply of paperwork. The number of entries were counted, including both entries and reviews required. From reviewing the data and identifying unnecessary activities, the following changes were implemented, which complied with ICH Q7:

Eliminated excess labelling of drums
Reduced the number of certificates of analysis supplied from 2 to 1
Standardised location of customer requirements from 4 locations to just 1
Eliminated non value added entry boxes and minimised number of review signatures
Design flow of form aligned to the work flow

Results / Outcomes:

Standardised Sales Picklist process to meet new electronic system work flow
Reduced the number of entries by 41%
Redesigned Sales Picklist process to meet Quality requirements of ICH Q7
Project completed on time and on budget

To implement a Lean Transformation to enable business growth

Key Business Challenges and Project Objectives:

In April 2015, the milk quota in Ireland was removed, which resulted in Food Processing facilitates planning to increase capacity to match supply from Farmers. Our client, a leading provider of dairy produce to the Kerrygold brand decided in 2013 to deploy Lean into their organisation to prepare for this significant growth. They invited Crystal Lean Solutions to support this Lean Transformation.

CLS Approach and Changes Implemented:

Using the Hoshin Planning approach, CLS first worked with the Leadership team to determine and communicate the strategic goals of the business. Working across all aspects of the business, twelve Lean Six Sigma Green Belt projects were identified, training was completed and projects mentored and managed through a new Project Management Process. Project leaders included Production Operators, Laboratory technicians, Supply Chain and Managers. Other Lean elements implemented included:

5s (A place for everything, communication boards, information boards, signage) in production
Balanced Scorecards to manage Operations and Health and Safety performance
OEE program to understand and reduce the main contributors limiting production performance
A cross functional communication process to manage daily production

Results / Outcomes:

Achieved €300k cost savings (annual)
Introduced a process based approach to systematically manage the business
Introduced a culture of data based decision making
5s provided a foundation to compliance to Food Quality standard

Streamline Accounts Receivable Process to Improve Cash Flow

Key Business Challenges and Project Objectives:

As a Healthcare provider, our client responds to sufficient customer demand. Similar to many businesses, although continuing to grow, cashflow into the business was a significant challenge on a monthly basis. Crystal Lean Solutions were invited to work with this provider to help streamline the accounts receivable process. In this environment, the Insurance companies represent the customer base, so the primary objectives of the project were:

To increase the value of claims process monthly by 30%
To increase the number of claims processed per month by 50%

CLS Approach and Changes Implemented:

Working with the cross functional project team, we delivered training on Lean principles and the DMAIC methodology. The team then mapped out the current accounts receivable process. One source of waste identified was the number of returned claim forms from the Insurance companies. The team completed a Pareto analysis of the main reasons for the returns. On reviewing the data and the non-value added activities in the accounts payable process, the following changes were identified and implemented:

A cross training matrix was developed and implemented in finance team
A standard checklist to review each completed form was implemented
A schedule of activities of the process was developed and agreed
Standardisation of codes for the claim form
Set up standard location for claim forms status

Results / Outcomes:

Increased cash flow from claims by 45% monthly
Increased number of claims processed by 54% monthly
Increased level of skills in within finance team to increase flexibility and flow of claims

To increase Productivity to deliver Business Growth

Key Business Challenges and Project Objectives:

Over the past 4 years, we have partnered with a leading Multinational Medical Devise organisation, who operate in a highly regulated yet cost competitive environment. To address these cost reduction demands, the company recognised that engaging the people on the assembly line would be the critical success factor to improve and sustain productivity. Crystal Lean Solutions was invited to:

To facilitate the engagement of two teams
To facilitate the improvement in productivity of the two assembly lines

CLS Approach and Changes Implemented:

Working with the project teams, CLS first mapped out current status of the cross functional team members in terms of working relationships using RC. From this initial analysis, an action plan was developed and implemented to maximise team member engagement. CLS then facilitated an offsite workshop with the assembly line team members, requesting their feedback and brainstorming improvement ideas to achieve productivity goals. The following key changes were implemented:

Team members were provided with customised training on key lean principles that may trigger ideas for improvement
Team members were encouraged to provide their improvement ideas to achieve productivity goals
Ideas generated on the day were implemented when teams returned on site
Communication process was improved through e-mails, noticeboards and rotation of team to project reviews
People were recognised for their contribution to the success of the project

Results / Outcomes:

Increased and sustained average shift productivity by 32%
Implemented a communication process across shifts and between shifts and project leaders
Increased employee engagement and innovation

Streamline Bottleneck Process to Deliver Capacity and Cost Savings

Key Business Challenges and Project Objectives:

Our SME client (less than 10 people) is a leading supplier of Engineering Goods and Services to the Marine and Industrial markets in Ireland and into Europe. Given the nature of the service provided, the company responds to address unplanned events at the clients’ facility. A key challenge for the business is to continuously reduce costs while simultaneously responding to unplanned customer requirements. Crystal Lean Solutions developed the following program objectives in collaboration with the team:

To provide employees with a foundation in Lean principles and its benefits.
To reduce the Change Over Time of the Purification Process by 50%.
To implement 5s at the Manufacturing Process.

CLS Approach and Changes Implemented:

With the cross functional team, the process was described at the actual workplace and then mapped. All sources of waste were identified and then prioritised by the team for elimination. Solutions to eliminate the “top 5” waste activities were then brainstormed and the following changes were implemented over 4-month period:

All tooling, equipment and consumables required for the Purification changeover are at point of use in the correct quantity.
Colour coding of critical connectors with a tag system to communicate status of use.
5s of the process (signage and labelling) was implemented to minimise search time.
Utilisation by the team of the A3 Report to manage the project.

Results / Outcomes:

Release of €40k Additional Capacity for the business
Annual cost savings of €40k
Reduced changeover time by 43%
Certified Lean Yellow Belts for Lean training and project execution.
“Improved the quality of the service provided to clients”

Streamline the Value Stream Processes to deliver Growth Capacity

Key Business Challenges and Project Objectives:

Our client manufactures a wide range of veterinary pharmaceutical products. These products are sold in over forty countries worldwide under our client’s brand name and also as branded products of other major multinationals. Our client has 50% growth forecasted year on year sales for the next 3 years. To facilitate this rapid growth, our role was to enable the organisation to streamline its current value streams through the EI LeanPlus program.
The Programme objectives were:

To release at least €1M in additional production capacity on a number of critical manufacturing lines by reducing batch changeover times.
To achieve at least €100k p.a. savings on material and running costs by reducing waste
Improve factory visual appearance

CLS Approach and Changes Implemented:

Working with three cross functional teams, we utilised a Kaizen based approach to map out the process, identify sources of waste and developed and implemented improvement plans. Our action based focus enabled to teams to make changes in the short, medium and long term, resulting in the following changes:

Manufacturing Line – Using SMED, changeover times were reduced by 50%
Manufacturing Plant – Using the 5 Lean Principles, the average number of daily batches were increased from 2.5 to 3.0
Packaging Line – With a focus on the 7 sources of Waste and 5s, the clearance time was reduced from 30 minutes to 20 minutes

Results / Outcomes:

The targets set were exceeded and following were the highlight results:

Total additional new throughput capacity of €1.141M achieved
Annual running costs reduced by €119.2k
Improved factory visual appearance
Improve interdepartmental communications
Improved GMP (Good Manufacturing Practice) compliance

Improve Bottleneck Process throughput to deliver Growth Capacity

Key Business Challenges and Project Objectives:

Our SME client are experts in the provision of high precision CNC machined products and operate in a highly cost competitive environment. Crystal Lean Solutions were invited to work with and enable the team to deliver cost reductions through the EI LeanStart Program over a 3-month period. The following objectives were identified:

To reduce the Change Over time of the bottleneck process
To implement an organised workplace through the 5S deployment

To support the development of the Leadership and staff teams to deploy and sustain Lean into the organisation

CLS Approach and Changes Implemented:

Utilising our flexible yet innovative approach, we provided training and action based learning to enable the team to identify and implement changes to the process. Using both the SMED (Single Minute Exchange of Dies) and 5s (workplace organisation) Lean methodology, the following changes were implemented:

All tooling required for the bottleneck Machining Process is now at point of use
Training sheets were implemented for effective operation of each Machine Process
Improved communication of knowledge between personnel, through the introduction of critical to quality information on the drawing/programme.
70% of the workplace is not set up in an organised way.
Project was managed using an A3 Report.

Results / Outcomes:

The key results from the Lean Start Program include:

Released €152k Additional Capacity (15%) for the business
Reduced changeover time by 19%
Reduced search times by 6 hours per week
Certified Lean Yellow Belts for all team members