Facilitating Quality Management from a People and Process Perspective     

Proactive Quality Management services with an eye for “Quality Beyond Compliance”

by Henrieke de Bie

 

Quality beyond Compliance

Establishing “first time right” in your organisation through quality by design, quality risk management and a transparent quality culture

Training and Mentorship

Bringing your staff to a next level in critical thinking, quality culture management, behaviour change, strategic and operational audit and quality management

Business Optimisation

Supporting your organisation in setting up or optimising the governance framework, QMS and/or processes related to clinical research or PV

Why Beyond Compliance?

Beyond Compliance has been set up in 2021 to partner on a global basis as a trusted advisor for quality culture and operational excellence activities with organisations in a period of growth or change, or with a desire to improve their quality management system and/or employees’ quality mindset.

Beyond Compliance supports companies in embedding quality and compliance into their organisation, while specifically looking at quality “beyond compliance”.

* What does that mean?

Beyond Compliance works at the intersection of quality management, people and team development and behaviour science. Beyond Compliance supports companies in understanding, evaluating and creating a quality culture, through optimising the way they work and think, to ensure high quality, efficient and -where relevant- regulatory compliant processes.

By providing training, workshops and lectures, and by providing project-based support, Beyond Compliance facilitates organisations in cultivating critical thinking and the right quality habits, which, in combination with a robust, but bespoke and efficient quality strategy, should result in a healthy quality culture.

* Why is it so important to focus on a quality culture?

Traditionally, quality management tends to focus primarily on the processes and systems. More focus also on the human (or behaviour) side of quality management can ultimately lead to a greater cost reduction and an increased efficiency, in a positive working atmosphere.

A quality culture will help organisations in doing things the “first time right” and makes sure they are continuously audit- and inspection-ready through:

  • Building quality and compliance into the design of processes, systems and projects; and
  • Adequate management of quality risks.

This cannot be successful though without:

  • Building quality into the organisational structure, management and communication; and
  • Motivated, quality-minded individuals who feel supported and comfortable to speak up, establish critical thinking and share ideas.

Beyond Compliance is ready to support in taking the first or the next steps in creating the right quality culture for your organisation.

Quality beyond Compliance

Quality means doing it right when no one is looking”  (Henry Ford)

Striving for high quality does not go without an investment to ensure the right culture is in place to sustain the employees’ intrinsic motivation to show continuous quality and compliance behaviour.

A quality culture is an organisational culture where a continuous aim to deliver quality is embedded in all operational aspects of the company, in explicit ways (procedures and activities) and in implicit ways (values, behaviour and attitude).

Beyond Compliance supports organisations in creating a quality culture, in defining and optimising their quality strategy, procedures and systems, and in creating quality habits throughout the organisation.

1. Quality by Design

By investing at the upfront through building quality into the design of your processes and studies, time and costs can be saved at the backend. First time right through quality by design does not only save time and costs, but it also motivates employees and creates trust with regulators, patients and (other) stakeholders. 

Beyond Compliance can act as a catalyst for incorporating a quality by design approach into your organisation through e.g. creating awareness and bringing teams together to investigate opportunities for improvement.

Beyond Compliance can also help your organisation with creating the structure of an effective governance framework including a bespoke Quality Management System.     

2. Quality Risk Management

A key enabler of quality by design is quality risk management (QRM). QRM starts with identifying a set of critical to quality factors relevant to your processes or study, followed by risk identification, evaluation, control and communication. Risks and mitigating actions taken should be reviewed on a regular basis to assess effectiveness and the quality risk management approach should be reported.

Beyond Compliance can support in developing a QRM process and, as desired, can facilitate risk management activities and/or train individuals to act as risk management facilitator for their organisation.

3. Quality Culture Optimisation

Building a quality culture is often led by a quality department, but wouldn’t you need ambassadors throughout the organisation? A quality culture should be supported by management, empowered by employees at all different levels in the organisation, in an environment of trust and respect. 

Beyond Compliance can:

– Provide training, create awareness and organise workshops, to open the discussion around the enablers and barriers to establish an organisational culture that has the right conditions to encourage sustainable quality and compliance behaviour.

– Support companies in definition, assessment and optimisation of their quality culture.

– Advise management, operational and quality teams in strategies to embed sustainable quality habits in an organisation.    

 

Training and Mentorship

Training sessions or workshops are so much more effective when they do not only include the “what” and the “how”, but also the “why”.

Beyond Compliance offers class room, personal and on-the-job training or workshops as a stand alone activity or as part of a larger project. Awareness will be created by making use of examples, exercises and open discussions, in which the trainer / mentor will not shy away from sharing personal experience. 

Key words: passion, energy, dialogue, critical thinking.

 

Services include training, workshops and/or (individual and/or on-the-job) mentoring in several areas, such as:

  • Cultivating Critical and/or Risk-Based Thinking (for (quality and operational) management and teams)
  • Optimising Engagement between teams, departments and/or other stakeholders
  • Quality Culture development
  • Behaviour Change
  • Strategic Quality Management
  • Setting up a Quality Management System 

Training and workshops can or will be custom-made.   

Business Optimisation

With more than 24 years of experience in the life science industry, almost 17 years in quality and compliance, in both operational and leadership roles, and academic education in quality management, Beyond Compliance can support your company in process optimisation and clinical, pharmacovigilance and/or general quality management activities.

Beyond Compliance looks at quality “beyond compliance”, in which an open dialogue is considered essential to facilitate effective, efficient and innovative approaches to quality.

 

Services include:

  • Development of a bespoke Clinical / PV / General Quality Management System (QMS) / governance framework
  • Clinical / PV / General QMS and process gap analyses
  • Operational excellence and clinical / PV process optimisation (e.g., further optimisation of a QMS and/or governance framework)
  • Continuous inspection readiness support (through training and workshops)
  • Strategic quality management advice, such as brainstorming about a company quality strategy or a quality approach for first in-human studies, support in seting up a quality management approach or department, ad hoc quality support in clinical research  

About

Beyond Compliance, based in Deventer, the Netherlands, has been established in August 2021 by Henrieke de Bie.

Henrieke has more than 24 years of experience in the life science industry in different areas, with a primary focus on clinical research and pharmacovigilance.

With experience in fundamental lab research and as a GMP Quality Manager at a pharmaceutical plant, Henrieke started her clinical research career in 2001 as an all-round Clinical Research Associate managing clinical trials ranging from phase 1 until / including phase 4.

In 2007 she moved into quality assurance. Since then she has worked in different international auditor, consultant and strategic leadership roles in large contract research organisations, consultancy firms and pharma/biotech. In these roles she performed ~200 multiple day audits in 35+ countries, supervised large audit programs, supported regulatory inspections (including EMA, MHRA and FDA) and managed several international clinical / PV quality teams.

In 2021 Henrieke decided to leave her position as Director PVQA at Astellas, to start her own company Beyond Compliance, primarily focusing on projects which can help organisations to optimise their quality culture, which can help them to avoid audit findings, to be inspection-ready, to reduce costs and to make optimal use of resources through a first time right approach.

 

 

 

Next to a propaedeutics in Medicine and a Bachelor in Biochemistry (Cum Laude), Henrieke holds a Master of Science in Quality Management in Scientific Research and Development from the Cranfield University (UK), for which she won the Prize for the Best Student in 2018.

Henrieke completed her Master study with a thesis titled “Quality Culture in the Pharmaceutical Industry: Awareness and Assessment in Clinical Research, compared with Manufacturing”.

In addition, Henrieke followed intensive post-academic courses in behaviour science and leading cultural transitions from people perspective.