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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

The Ask:

A traditional Scotland based luxury goods company was acquired by a global giant who defined, following Big 4 strategy review, that the business model required changing. The task was to develop a rapid deployment plan and an implementation programme that minimised business disruption during the crossover.

Results and Benefits

  • New facilities designed and sourced in line with future requirements
  • Complete cessation of producing non-core brands
  • Phased exit from supplying retailer brands
  • Cessation of all trading activities
  • Assets refocused on productive high profit brands
  • Retailer allocation of products to allow rapid export expansion
  • Future workforce selection and successful redundancy programme
  • Effective stakeholder management
  • On-time and on budget delivery of original plans (£45.0m)
  • Divestment of non-core brands
  • Avoided business disruption
  • Significant increase in unit price and subsequent profitability

Challenges:

  • Dated production and office facilities in contrast to the owning company’s philosophy.
  • Non-performing brands consuming management time and production resources
  • Too much emphasis on retailer brands and non-branded products.
  • Contract manufacturing at marginal costing to make the numbers work.
  • Trading product rather than direct selling at significantly reduced margins.
  • Ageing assets consuming excessive overheads, cost and reducing levels of efficiency and productivity.
  • Retailers forcing the unit price point down.
  • Difficulty with trade unions.
  • Ageing workforce with minimal succession planning for core skills.
  • Lack of employee training and development across all functions.
  • Producing cheaper products to sustain nominal profitability.
  • Ineffective marketing defining the product position incorrectly.

Implication

  • A continued expansion into non-branded product areas leading to a continued slide in profitability.
  • Lack of continued support from the new owners, and possible re-sale.
  • Mediocre future performance and a risk of failure, assets, workforce and markets.

Objective

  • Develop and deliver a plan to achieve the strategic roadmap in all aspects.
  • Removal of dependence on retailers and non-branded activities.
  • Re-design and source new facilities for production and headquarters.
  • Relaunch the business in accordance with the owners philosophies.
  • Engage and upskill the workforce.

The Approach:

Develop a plan for a plan incorporating the Big 4 strategic review, the owners philosophies, local management interpretations and workforce stakeholder management including the Scottish government and unions.

Prepare quantified budget assumptions for the end to end transformation.

Engage retailers proactively to minimise business continuity disruption.

Develop an effective communication programme to avert bad press and workforce action.

Toolkit

  • Strategy simplification
  • Data collection & analysis
  • Value Stream Mapping
  • Product costing assessment
  • Design for future manufacture
  • Solution verification
  • Supplier positioning
  • Customer and market positioning
  • Stakeholder management
  • Brand value assessment
  • Forward capacity modelling
  • Workforce assessment
  • Workstream management
  • Steering group management
  • Key Performance Indicators
  • Business impact sensitivity modelling
  • Budget modelling

The Ask:

A global pharmaceutical company was looking to setup a Project Management Office (PMO) to support their external manufacturing business.

Scale:

  • 100+ live projects
  • 102 products/3000+SKUs
  • 183 external network sites

Results and Benefits

  • Dashboard developed for live, up to date clarity on project status
  • Portfolio metrics, clarity on project status & reduced project report meetings
  • Standardised project tool kit developed for each phase of the project lifecycle
  • Budget management and reporting process developed
  • Portfolio governance board & Business Unit forums setup
  • Roles and responsibilities developed across the project lifecycle
  • PMO governance policies developed
  • Project managers trained to the same standard and ongoing PM support installed
  • Project portfolio reporting capability – Quarterly reports submitted to the executive team
  • Guideline documents and templates developed for each phase of the project lifecycle
  • Clarity for internal management on resource utilisation and approval

Challenges:

  • Extremely large and growing project portfolio
  • No definitive source of transparency on the capital investment & resource demands
  • No executive view for portfolio status
  • Highly diverse range of projects:
    • Extremely large and growing
    • Complex technical transfers
    • New market introductions
    • Equipment and facility upgrades
    • Business continuity projects
  • Project managers experience and training varied greatly
  • No effective budget tracking/reporting against projects
  • Key internal processes such as technical transfers not mapped to the project lifecycle

Implication

  • Significant company revenue tied to the project portfolio, not visible
  • Repeated questions & confusion surrounding project finances
  • Business risk: Lack of clarity surrounding business continuity projects
  • Over reporting, frustration, lost time and risk due to lack of transparency

Objective

  • Develop a standardised tool kit to support the project requirements
  • Develop a reporting structure to facilitate clear project status reporting
  • Roll out project management training to the internal team and across the divisions
  • Setup portfolio governance – Decision making and prioritisation forums
  • Minimise the amount of direct reporting required
  • Establish appropriate project portfolio metrics to support management
  • Develop resource management capability

The Approach:

Toolkit

  • Voice of the Customer
  • PMO User Requirements Specification
  • Project Approval & Communications Plan
  • Process Mapping
  • Project Charter
  • Project Work Breakdown Structure (WBS)
  • Project Budget Template
  • Project Dashboard
  • Project Risk Register
  • Project Management Training
  • Business Unit Programme Reports
  • Resource Management Template
  • Resource Management Tracker