+44 (0) 113 868 0522 | +353 (0) 76 680 3555       info -at- explic8 -dot- com

A major coach and bus manufacturer was considering closing one of its manufacturing sites in the UK as it was not performing; it was a loss making site; quality was poor, and it was market contracted by over 20%. Pressure was coming from the company’s joint investors who perceived that there were inefficiencies and over capacity across its operational sites in Europe.

The company engaged Explic8 to review its operations and provide a road map to avoid site closure.


The Challenge

The quality of output had slipped significantly while costs increased, and customers were becoming frustrated. The site was set up to produce both coaches and buses but was doing neither well.

The site was sprawled over 600k ft2, comprising several buildings. Part-built vehicles were being towed between buildings to complete the manufacturing process, exposing them to the elements and creating significant inefficiencies.

In addition, every vehicle was taking up to 20 weeks to build and each one was a loss-maker as they had been costed on a superseded design that gave them the ability to produce 1200 vehicles annually, but this was no longer the case.

It was clear that a radical shift was required to give the company any hope of retaining the site. However, with a ‘died in the wool” unionised employee base, workers had historically benefited from powerful union control. This dominance created an environment that was not conducive to change.

The Ask:

A global medical device company, a Top 100 ASX performer, launched a new product range which was well received in the market with indications of good sales potential. However, manufacturing output simply could not meet the demand and customers were becoming increasingly frustrated at not receiving their orders on time

Results and Benefits

  • Output raised from 300 units per month to 4,000 (a 13-fold increase)
  • 80 good units per shift produced with 7 people (a 70-fold increase in productivity)
  • Quality – increased to an average 90% first pass yield
  • First completed works order achieved 98% yield (company record)
  • Manufacturing Cell implemented
  • Manufacturing lead time reduced from over 45 days to 1 day
  • 100% on time delivery
  • Skills matrix developed / Team cross training for job rotation
  • Avoidance of overtime and recruitment
  • No increase in overheads
  • Reduction in WIP

Challenges:

  • The product range consisted of 2 main products which, with 4 colour variants (and 2 more to be launched), yield 20 SKUs and 120 accessories
  • The output level was supposed to be 1400 units per month with aspirations to raise output levels to 3000 units per month over 6 months
  • Throughput levels and yields were lower than target but were expected to rise with production experience (the actual output was 300 units per month)
  • There were quality, quantity and timeliness problems with deliveries of bought-in components
  • The high failure rates of incoming components and assemblies consumed valuable trained resource to rework failures and therefore, reduced capacity
  • The operation was labour intensive with 30 people employed on 8hr shifts plus overtime and around 10 on afternoon shifts
  • There is no automation, each piece is hand-built under microscopes
  • The average lead time to produce one unit was in excess of 45 days

Implication

  • Recruitment and training is long and difficult because each operator is highly skilled, therefore, the only capacity flexing is with overtime
  • In order to hit output targets the company was considering recruiting and training 40-50 more employees

Objective

  • To provide an end-to-end value stream map of the new product range identifying opportunities for improvement, designing how the processes should operate and implementing a manufacturing cell structure which will achieve the company’s desired output and quality targets without increasing head count, labour cost and overhead

The Approach:

Changes were implemented within the company’s framework of:

  • Internal organisation structure
  • Regulatory and compliance requirements
  • Incoming Inspection and GMPs
  • Document control and SOP processes

Toolkit

  • Data collection & analysis
  • Value Stream Mapping
  • Design for manufacture and assembly
  • FMEA
  • Cell design
  • Solution verification
  • Implementation
  • Supplier positioning
  • Strategic Sourcing
  • Vendor Managed Inventory
  • Supplier assessment
  • Batch order quantities
  • Kitting
  • Key Performance Indicators
  • Visual Factory Management
  • 5S Housekeeping
  • Team Briefings
  • Continuous Improvement

The Ask:

A global medical devices company under consent decree for 2 years across two sites

Findings:

  • FDA Audit in 2013 (21 483s were issued)
  • Quintiles audit in 2015 (91 Findings were issued)
  • Also included in the scope were Dekra & TGA findings

Summary: 112 Major Findings, 408 Minor Findings. All business areas Impacted

Results and Benefits

  • Programme structure designed & implemented based on 21 CFR 820
  • Easy, live tracking and management of the remediation programme
  • Critical processes – back logs removed and operating effectively
  • Project teams initiated, planned, and moved into successful execution
  • Project team members engaged and motivated – 191 Team members
  • Bi-Monthly communications with the FDA, format designed and implemented
  • Effective project metrics and reporting providing clarity to the organisation
  • Project tracking ahead of target – Transition of the programme management team
  • Internal team – Complete ownership & management of the remediation programme

Challenges:

  • The organisation had engaged with a number of contractors, structure was fragmented and not yielding results
  • The systemic issues which had led to many of the findings were directly preventing the organisation from addressing the findings effectively
  • The organisation had been living with these findings for the past four years – motivation was low and successful remediation seemed unlikely to many
  • Resources across the organisation were heavily loaded with day to day operations

Implication

  • Risk to patients due to non-compliant systems
  • Fines for non-compliance from the FDA
  • Risk of losing market share – Current Market Leader
  • +$400 Million in annual sales at risk
  • Risk to future growth in the organisations largest sales income market

Objective

  • Design a programme structure to facilitate effective remediation
  • Coordinate resources in an effective manner
  • Design a programme with measurable outputs and milestones
  • Develop a communications plan and format between the organisation & the FDA
  • Identify the required resources required to support the remediation works
  • Address the systemic issues – CAPA & Complaints system backlogged & non-compliant

The Approach:

  • 9 Program teams (2 Design teams) developed based on the 15 Subparts – 21 CFR 820

Success Enabling Systems Leaned:

  • CAPA system
  • Complaints Management System
  • Change Control System
  • Nonconformances
  • NVA steps removed processes refined

Toolkit

  • Lean tools and techniques from VSM – Utilised to address critical processes
  • Workload balancing for team scope development
  • Programme Management Team installed
  • Work Breakdown Structures & Status Report Templates
  • Progress & Compliance Tracking Database

The Ask:

A leading manufacturer of electronics for the communications industry that was struggling to achieve customer demand. 4-week delivery promise was failing to attain even 50% OTIF within 7-weeks. Over 700 employees and on a recruitment drive to try and match demand. Despite this performance, sales were spiralling and overtime was “the norm” to try and catch-up

Results and Benefits

  • Initial pilot cell reduced space required from 45k ft2 to 15k ft2 of factory
  • Cell produced 66% of total demand with a team of 25 team members (was 120)
  • 6-weeks of stock around the factory eliminated completely
  • Moved to flexible cell, single-piece flow with Kanban control between equipment
  • Overtime for the pilot product was running at 20% of factory and became zero
  • The 7-week for 50% OTIF delivery became an achieved 1-week delivery @ 100%
  • Lean concepts and cells rolled-out across all areas within a 12-month period
  • Work rebalanced to be achieved with a fixed workforce of 150 (from 700 and rising)
  • Live and accurate order status progress visible at all times within the Visual Factory

Challenges:

  • Massive overdues and everyone chasing their own tails to move products around the factory
  • The layout was functionally organised with large batch production and significant amounts of WIP, totally uncontrolled
  • Priorities changing within each day according to which customer was shouting the loudest (both internal and external customers complaining)
  • No visibility of job status – current batch methods were out of control with WIP piles everywhere, no evidence of batch control or lot control so jobs were being repeated
  • Plan was to invest in more buildings, equipment and people to quell demand

Implication

  • Key accounts were threatening to take their work elsewhere
  • Threat of line stoppages at customers being charged back to supplier
  • Significant hit to the organisation’s bottom line in large scale discounting to appease the customers
  • Company seriously considering asking their “smaller” customers to go elsewhere

Objective

  • Stop the bleeding and the pain
  • Understand if there truly were capacity issues or if the situation was just a symptom of current ways of working
  • Achieve stability, then visibility, then capability
  • Establish a better way of production that will regain control and give the company a breathing space
  • Prove the concept and roll-out across all product lines

The Approach:

Benchmarked current performance against the competition to identify where they were against the rest.

Analysed current processes, methods and flows to identify bottlenecks and opportunities.

Defined and designed a new way of working.

Reviewed product portfolio to select a pilot to demonstrate potential and would have the biggest impact for the business.

Roll-out successes across all areas.

Toolkit

  • Factory redesign
  • Lean tools and techniques from VSM to cellular design
  • Work balancing and competency and skills matching
  • Single piece flow and Kanban concepts
  • Meaningful, accurate and timely KPIs at point of use
  • Visual Factory

The Ask:

A global medical devices company wanted to embark on the implementation of the EU MDR.

Scale:

  • 250+ Technical Files
  • Seven global locations

Results and Benefits

  • Project teams traceable to the EU MDR 2017/745 – MDR “To Do” list
  • Easy, live tracking and management of the Global EU MDR program
  • Global EU MDR program successfully moved to stable execution
  • 87 Project teams initiated, planned, and moved into successful execution
  • 233 Project team members engaged and mobilised
  • Standardised toolkit utilised & knowledge sharing leading to reduced planning phase
  • Global governance structure & communication plan Implemented
  • Graphical toolkit utilised to facilitate remote & group collaboration
  • 8 Months – Start to execution phase for 87 project teams

Challenges:

  • Very little internal experience in large scale programme management
  • The organisation did not have the experience to bring a global programme of this scale through the required phases and into execution
  • ‘No internal’ toolkit to address a programme of this scale
  • To move a program of this scale required a distinct set of tools that were standardised, scalable and transparent
  • How to measure & track progress over the programme lifecycle? (4 Years)
  • Overloaded Internal Staff: How can we make this management as hands-free as possible?

Implication

  • EU MDR will be legally binding
  • Products not compliant to EU MDR will no longer be saleable in the European Union
  • Annual sales in excess of $300 Million at risk
  • Significant hit to the global organisation bottom line

Objective

  • Traceability from the project team scope to the EU MDR Regulation
  • Governance model & program structure standardised & scalable across seven global sites
  • Reduce the management burden of the program as internal staff are heavily loaded
  • Capability for live accurate transparent measurement of progress
  • Bring the program to stable execution before transition
  • Transition: Hand over the management of the program to the internal team

The Approach:

Toolkit

  • Explic8 EU MDR Gap Assessment Template
  • Explic8 Work Breakdown Structure Template
  • Explic8 EU MDR Status Report
  • Explic8 EU MDR Progress & Compliance Tracking Database

The Ask:

A global medical device company enjoying increasing market share was suffering an increase in high-value inventory because of QA test release lead-times.  The average time for final test/release was 8.6 days which meant that orders were held in the warehouse awaiting release.

Results and Benefits

  • Sample testing lead-time reduced from avg. 8.6 days to 1 hour
  • Guaranteed next-day results delivery for ALL lines
  • Inventory reduced from 9 days to 1 day
  • Inventory reduction provided one-off increase to profit line
  • Backlog of samples eliminated by existing staff without utilizing overtime
  • Cost of recruitment, employment and training of new staff avoided
  • No additional equipment purchased
  • No additional laboratory space required
  • The project won an international quality innovation award
  • The method of conducting the tests was used in this organization’s laboratories around the world

Challenges:

  • Testing lead-times were long (days) and getting longer
  • The number of samples being sent for testing was increasing
  • The backlog of samples awaiting testing was growing bigger
  • Current staffing levels could not cope with the volume of tests
  • Investigation procedures were complex
  • It took a long time to obtain results from the different tests and compile the report
  • Highly educated, experienced laboratory technicians were difficult to find
  • Recruitment and training lead times were long (months)
  • There was limited laboratory workspace for additional staff and test equipment

Implication

  • Unless the company changed its ways of working it would have to recruit additional staff to be able to cope with the testing
  • If more staff was recruited, more equipment would have to be purchased
  • If more equipment was purchased more space would be needed to accommodate it
  • To provide more space, a new laboratory would have to be built

Objective

  • Plan, implement and project manage a radically different method of laboratory management to:
  • Reduce time taken to conduct tests and publish results
  • Reduce the backlog of samples awaiting testing
  • Reduce the cost of inventory
  • Implement next day delivery for key lines

The Approach:

Toolkit

  • Workflow simplification
  • Lean sampling-handling Process Re-Engineering
  • Workload balancing
  • Planning and forecasting
  • Restructured KPIs and business reporting
  • Visual Workplace Management