Proactive Quality Management with an Eye for Quality “beyond Compliance”
Where Quality meets Culture
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
Creating an open dialogue and culvating quality mindsets through combining knowledge with encouraging critical thinking and valuable collaboration
Business Optimisation
Supporting your organisation in setting up or optimising a risk-based quality management system and/or processes related to clinical research or PV
About
Beyond Compliance…
Beyond Compliance has been set up in 2021 to partner on a global basis as a trusted advisor in proactive quality management and operational excellence with organisations in a period of growth or change, or with a desire to improve their quality management system and / or their employees’ quality mindset.
By providing project-based support, training, workshops and inspiration sessions, Beyond Compliance facilitates organisations in fostering a healthy quality culture.
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Traditionally, quality management tends to focus primarily on processes and technology. More focus on the people side of quality management can ultimately lead to a significant cost reduction, an increased efficiency and a positive work atmosphere.
A quality culture will help organisations in doing things – as much as possible – the “first time right”, and will ensure continuous audit- and inspection-readiness through:
* Building quality and compliance into the design of processes, systems and projects; and
* Adequate management of quality risks.
This can only be successful with:
* Quality built into the organisational structure, management and communication; and
* Motivated, quality-minded individuals who feel supported and comfortable to speak up, demonstrate critical thinking and share ideas.
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Beyond Compliance is ready to support your organisation in taking the first or the next steps in fostering the right quality culture and cultivating quality mindsets.
Quality beyond Compliance
“Quality means doing it right when no one is looking” (Henry Ford)
When you strive for excellence, you need to invest in fostering the right culture. A culture which supports the employees’ intrinsic motivation to show continuous quality and compliance behaviour.
A quality culture is an organisational culture where the aim to continously 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 such a quality culture, by defining and optimising the quality strategy, procedures and systems, and by creating quality mindsets 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. Risk-Based Quality Management
A key enabler of quality by design is risk-based quality management (RBQM), an essential element nowadays in clinical trials, but absolutely relevant also in other GxP areas. RBQM 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 risk-based quality management approach should be reported.
Beyond Compliance can support in developing an RBQM 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.
Training and workshops will be custom-made and are ideal for a team event.
Beyond Compliance also offers inspiration sessions and delivers key notes during conferences and events.
Key words: passion, energy, dialogue, critical thinking.
Examples:
- Workshop “Why don’t they do what we want them do to?!” (min. 1/2 day), consisting of an introduction into behaviour change, followed by exercises how to apply a behaviour change model in a real life example
- Foundation and Advanced Training Course “Clinical Quality Event and Serious Breach management”, based on social psychological elements to encourage crossfunctional collaboration and critical thinking
- Introductory training “Fostering a quality culture in a start-up or scale-up organisation”
- Lunch & Learn session “Quality is not an Act: It is a Habit!”
- Inspiration Session “A Quality Culture: Paving the way for Continuous Improvement”
- Interactive GCP or clinical safety training for e.g., newcomers or professionals working in GMP / GDP
Business Optimisation
With almost 25 years of experience in the life science industry, more than 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, change management and clinical, pharmacovigilance and/or general strategic / tactical 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.
Examples:
- Development of a new, bespoke clinical, PV or general Quality Management System (QMS) for a start-up company
- Gap analysis of a clinical, PV or general QMS or specific process (e.g., quality issue management), with or without additional support in further QMS or process optimisation
- Facilitating the introduction of a new clinical trial or PV process (e.g., implementation of an eTMF or eQMS)
- (Continuous) Inspection Readiness support (through e.g., mock interviews, training, workshops and / or document review)
- Strategic quality management advice, such as brainstorming about a company quality strategy or a quality approach for first in-human studies, support in setting 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 almost 25 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 / tactical 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 from people and process perspective, which can help them to avoid audit findings, to be inspection-ready, to reduce costs, resources and turn-over of staff.
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.
