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Category: Medical Devices

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 joint venture company was established in 1994 between the vaccine divisions of two global organisations to focus on marketing vaccines successfully in its territories.  A joint venture is an unusual commercial arrangement and brings its own challenges in managing the business in a highly regulated industry.  Explic8 consultants were asked to:

  • simplify and harmonize its current business processes into an integrated holistic process set that affords improved protection of patient safety and continues to meet all current and upcoming regulations, local capabilities, needs of its affiliates and shareholder requirements;
  • consolidate the safety management landscape from an organizational, process and technical perspective to improve performance and efficiency; and
  • take advantage of advancements in technology to realize the potential benefits of a new Safety Database implementation

Challenges:

  • Data entered into process from 12 disparate groups;
  • There were 8 different process variations between the groups;
  • There was variability in the time taken for each of the process steps
  • Process heavily paper dependent;
  • Case file took four days on average to complete;
  • Submission compliance targets were not being achieved;
  • Company was facing increasing pressure to improve timelines and submission compliance;
  • This review had to be conducted in a very short space of time because the company was preparing for another imminent inspection.

Implications

  • Risk of non-compliance
  • Team was operating under pressure and had hosted 18 audits and inspections without critical findings during the year.

Objectives

  • Simplify and harmonize its current business processes; and
  • Improve compliance performance (internal and external)

The Approach:

  • Interviews conducted with:
  • Affiliate Offices,
  • Vaccine Safety Assistants,
  • Vaccine Safety Managers,
  • Vaccine Safety Data Managers,
  • Vaccine Safety Officer,
  • All PVRM Division Heads.
  • “As is” ICSR process & Risk Management workshop held;
  • Case timing data collected from Corporate and Affiliates
  • SOPs reviewed (Case Processing, Safety Monitoring, Crisis Management);
  • Data from ARISg, AESI, RMPs and Safety Findings reviewed;
  • Findings compared to Industry Benchmark data.

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

  1. CAPA Management;
  2. Process Mapping and Process Re-engineering;
  3. Document Control and Training;
  4. Changes to departmental organisation and process ownership;
  5. 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

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

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

  • 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

Objectives

  • 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

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

  • 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

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 Challenge

A global medical device company was unable to supply its products to the market because of delivery failures from vendors.

The company was so frustrated, it was considering building a brand-new, giant warehouse facility to hold stock of the offending items.  However, this strategy was fraught with issues such as cost of buildings, increased stock holdings, increased transport costs, effect on cash flow and profit and the time taken to plan and build.