How do we introduce and standardise a global Integrated Business Planning Process?
Need to expand focus and integration of new, growing, strategic market.
Focus on Innovation and Technology and global process step integration.
Challenges:
The monthly IBP process had traditionally been driven by demand from the Americas and did not include EMEA or Asia-Pacific demand
There was ineffective integration of data from a new and developing global market. This led to poor forecasting of customer demand, raw materials, capacity, and labour, as well as reactivity and fire-fighting, opposed to proactivity
Coupled with poor data integration, the business IBP cycle had become routine, “data heavy” and suffered from team members “going through the motions”
The initial IBP process was more than 15 years old, and data complexity, accuracy and integrity had degraded over time
The traditional, base business dominated the process. Stronger integration of the new growing market needed to be undertaken to facilitate strategic execution
Strategic growth in a new global market would challenge global capacity. An upgraded IBP process was critical to forecast when investment was needed to deliver increased capacity; especially with commissioning lead times of 12-18 months
The Approach:
Assembled a design team with leaders of each process step within the IBP process
Comprehensive evaluation of current state – Process, Data, Organisation, Inputs/Outputs
Education related to the evolution of S&OP into IBP and the importance of scenario planning
Analysis of data inputs and outputs to evaluate if data complexity could be reduced Innovation, Project Mgr. and Portfolio Mgt.? Where to meet the customer? Planning materials for demand forecasts? Strategic Material Supply? Inventory Planning? Financial Forecasting?
Process mapping for current state and future state and identification of process change using IDEF0 and Kaizen principles
Requirement to build standardised process – data, people, process steps and presentations
The Achievements
Complete process redesign which included standardised process, input and output templates, RACI associated with each process step and significantly reduced cycle process time
An IBP process which acted as a conduit between short- and long–term horizons
An upgraded process that provided better focus and integration of an important market that will drive strategic growth
Improved Product Management Review process that was now capable of managing NPD through to product launch and understanding its impact on market share and portfolio management
Enhanced integration to deliver capacity scenarios and investment requirements that were driven by global market growth and market share expansion forecasts
An IBP process cycle that was reduced from 28 days to 5 days which had a significant impact on process data integrity
A focus of “Learn by doing” understanding that forecast data is inherently lacking in accuracy, but the team would constantly strive for data accuracy improvements
The Ask:
A global pharmaceutical company wanted to develop a QMS narrative document to outline the vision for a business-oriented quality management system, that actively supports the competitiveness of a modern pharmaceutical company in a rapidly changing healthcare environment and which would maintain regulatory compliance in all markets. explic8 was asked to develop solutions to the following questions:
How do we create a rapid transition from traditional pharma product development to innovative and integrated healthcare solutions with expertise, processes and governance structures which are ideally suited to support complex projects?
What are the implications for leadership, structure, governance, and team composition to build mutual understanding and effective execution?
Results and Benefits
The novel QMS framework that was developed is characterized by two key statements:
The QMS contains three axes – People, Process, and Programs and provides a clear and stable structure, and the realignment and optimization of Teams, Plans, and Roles within it creates a dynamic environment that is agile and governable;
The emphasis on Teams, Plans, and Roles allows the execution of programs of all degrees of complexity and innovation, each with its own ‘sweet spot’ in the framework, to supporting maximum agility without being at risk of leaving the protective boundaries of the QMS.
The stakeholders agreed that the framework is a viable Transformation Framework for a successful PD transformation, to achieve the client’s vision.
Challenges:
The company produces pharmaceutical products, delivery devices, diagnostic services and Patient Health Care devices;
Each of these is governed by different sets of regulations and ICH guidelines;
It is extremely difficult to embrace all of these governance structures into one QMS;
The senior stakeholders were in disagreement over the structure that the new QMS should take;
There were serious concerns about:
the governance of such a complex model;
whether innovative development projects could remain compliant within the QMS; and
The company’s capability to adapt to the change.
Implications
Risk of non-compliance
Threat to market position if the transformation is not successful.
Objectives
Develop a novel QMS approach that is agile, governable and supports the successful execution of innovative projects, whilst providing a stable framework that ensures the protective boundaries of a QMS would not be exceeded.
The Approach:
The project was proposed as a four-week effort by an explic8 senior consultant and a QMS consultant over a six-week period, with the following four phases:
Preparation phase: where explic8 understands the context of the QMS narrative effort and prepares 5-10 key stakeholders for their role in the project;
Interview phase: where explic8 engages said stakeholders to understand their requirements, expectations and potential concerns about the business-oriented quality management approach that should be reflected in the QMS narrative;
Analysis and consensus phase: where explic8 summarises and characterises the superset of requirements, expectations and concerns and drives consensus in the stakeholder group;
Closing phase: where explic8 redrafts the QMS narrative based on achieved consensus for adoption with final review, adoption by the stakeholder group and collective closeout meeting.
The Ask:
A global medical device company received an FDA 483 for failing to comply with the requirements of FDA QS regulations and ISO 14971 device quality system requirements for combination products in that:
a) the complaint and adverse event systems did not include provisions that allow for the review and determination of an investigation by the quality control unit;
b) product complaints were not opened at the time of AE triaging;
c) medical assessment requests for further investigations were not timely;
d) manufacturing-related investigations were not requested; and
e) no rationale was provided if a manufacturing investigation was not required.
The auditor concluded that the company was failing to ensure that post-marketing surveillance data was fed back into the risk management process to verify that the original risk determination was suitable and sufficient and that no new risks had been identified.
Results and Benefits
Simplified processes with clear ownership and responsibilities;
Fewer hand-offs meant improved communications between functions;
All findings were addressed to the satisfaction of the inspector;
the complaint and adverse event systems called for review and determination of an investigation by the quality control unit;
product complaints opened at the time of AE triaging or before;
requests for further investigations called for within 2 working days;
a rationale written if felt that a manufacturing-related investigations is not required;
post-marketing surveillance data is fed back into the risk management process closing the loop and future proofing against EU MDR requirements;
The FDA 483 warnings were removed for these findings.
Challenges:
Each of the complaint, adverse event and risk management systems were complex;
Steps in each process were owned by different functions with hand-offs between;
Quality and safety functions were not involved with R&D in the original risk determination;
Each team member was very busy with the focus on entering the data as quickly as possible;
Each function operated in its own silo;
No clear single owner of the overall Complaints/AE/Risk systems
Implications
Risk to patient safety due to non-compliant systems;
Fines for non-compliance from the FDA.
Objectives
Address each of the observations recorded by the auditor and verify that:
the complaint and adverse event systems do include provisions that allow for the review and determination of an investigation by the quality control unit;
product complaints are opened at the time of AE triaging;
requests for further investigations are made within time limits;
manufacturing-related investigations are requested if required and if not a rationale is to be provided;
post-marketing surveillance data is fed back into the risk management process.
The Approach:
A number of CAPAs were opened to address each individual section of the observations;
Root Cause Analyses were conducted for each;
The complaint, ICSR and risk management processes were mapped and re-engineered reducing the number of steps and hand-offs;
Clear process ownership was defined;
The supporting SOPs were amended through document control and approval;
Relevant staff members were trained in the amended SOPs and training records were kept;
Resources were reorganised with clear focus and objectives;
Team structure was redefined and implemented;
Clear KPIs and trending introduced.
Toolkit
CAPA Management;
Process Mapping and Process Re-engineering;
Document Control and Training;
Changes to departmental organisation and process ownership;
Setting clear objectives and measures.
The Ask:
A global medical devices company under consent decree for 2 years across two sites with a total of 112 Major findings and 408 Minor findings
Complaints accounted for 17 of the major findings
The Complaints handling department were struggling to close off complaints
Over 1900 open complaints with almost 50% in arrears (backlog) – the oldest complaint being 779 days (over 111 weeks)
On a daily basis, more complaints were being received than could be closed
The Head of Department could not see any way out other than to recruit
Challenges:
The organisational structure within the Complaints handling department was flat with handlers taking the “next” complaint – but everyone was “cherry picking” the easier and younger complaints
The process for Complaints handling was slow and complicated
The focus from the team was on daily business so backlog never addressed
Reliance on other stretched departments (RA) for information a bottleneck
The Department Head was proposing doubling the size of the complaints team
Implications
FDA findings would never close resulting in fines for non-compliance and risking future growth in their largest market (US)
Losing the US market would impact market share significantly
Existing complaints team members were suffering from stress, and absence due to illness in this department was the highest in the business
Objectives
Split the complaints handling operation into two: daily business and backlog
Coordinate resources in an effective manner – create new layered structure
Design a program with measurable to close the findings and reduce arrears
Redesign the complaints handling process using lean methodology
Identify the required resources required to support the remediation works
Address the systemic issues and internal constraints – both the CAPA & the Complaints system were backlogged & non-compliant
The Approach:
Identified the trend and introduced clear measures and targets to remediate the backlog
Reorganised resources with clear focus and objectives
Redesigned the process to significantly reduce the time per complaint closure
Toolkit
Workplace observations to determine closure methods, skills and rates
Lean tools and techniques to streamline the Complaints process
Team structure redefined and implemented
Clear KPIs, tracking and focus on oldest backlog first
Results and Benefits
Compliance to ISO 13485, 8.3 and FDA 820.198 restored
Backlog reduced from ~900 to a manageable 100 with all oldest aged closed
Daily business team operating to new process and back under control
Total Complaints reduced from over 1900 to ~ 250
Eliminated the need to hire any additional staff to the department (stopped 10-hires)
Clear KPIs brought control to the department and allowed close tracking of progress
Lean process absorbed some of the tasks from other constrained departments
Complaints findings completely closed-off
Team now focusing on achieving 98% closures of all complaints – industry Best Practice
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)
Results and Benefits
CAPA process related findings successfully closed
Easy, live tracking and management of CAPAs through the CAPA dashboard
Process improvements driven through the effective implementation of CAPAs
CAPA Review Board empowered and resourced to support CAPA owners
Timely closure of CAPAs increased to above 95%
CAPA owners supported through periodic CAPA Review Board meetings
Effective CAPA metrics and reporting providing clarity to the organisation
Senior management informed on CAPA progress and risks through the dashboard
CAPA cultural shift – CAPA now viewed as a business improvement tool
Challenges:
16 Findings relating to the CAPA process have been issued in the past three years
The organisation is under FDA consent decree
267 open CAPAs exist within the CAPA system
CAPA forms are not fully aligned to 21 CFR 820
On-time CAPA closure is below 30%
Findings relate to:
CAPAs not addressed in a timely manner
CAPA tracking
Adherence to the CAPA process
Handling of corrective actions
Effectiveness of corrective actions
Implications
Risk of non-compliance, further findings result in FDA fines and potential removal of product from the market
Potential to implement much needed improvements and remediation at risk
Objectives
Potential to implement much needed improvements and remediation at risk structure and the metrics used to track manage and report
Develop clear metrics and KPIs for the CAPA process
Define clear triggers and escalation paths
Develop the correct governance and tools to support effective CAPA management
The Approach:
Map the current CAPA process and identify gaps and areas of improvement
Build a CAPA toolkit based on industry best practice
CAPA management team installed & empowered to support the organisation CAPAs
CAPA findings addressed and closed
CAPA process audited for compliance
Toolkit
CRB (CAPA Review Board) Installed
Roles & responsibilities defined
CAPA management metrics & KPIs
Escalation triggers developed
CAPA dashboard developed & launched
4 Square CAPA reporting template
Effectivity tracking to closure
CAPA integrated into the business process
Implementation of trend analysis
CAPA training rolled out
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
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