With a background in the pharmaceutical industry, the Danish Medicines Agency, my own consultancy service etc. – and most recently as a long-time quality manager in the fertility industry, I am used to preparing, implementing and maintaining quality systems. This involves managing all phases of a product’s or service’ life cycle – from the design-phase through the production-, use- and service-phases, to the product being safely discarded or recycled.
Quality management is an ongoing process of detecting and reducing/eliminating errors – and thereby improving internal practices in manufacturing, streamlining supply chain management and improving the quality of the business’ outputs and customer experience. It aims to hold all stakeholders involved in the production process – accountable for the overall quality and thus requires everybody to work together to improve products and services. Evenually, quality management aims to hold stakeholders accountable for the culture of the company itself.
At its core, quality management is a business philosophy that champions the idea, that the long-term success of a company comes from customer satisfaction and loyalty. An approach I very much agree with.
In view of this, LHR Consult offers the following services:
- Providing advice and consultation on quality planning, quality assurance, quality control and quality improvement.
- Acting as Quality Responsible.
- Preparation of quality systems and documents (e.g. quality manual, policies and standard operation procedures).
- Change control management.
- In-depth reviews and optimization of existing quality processes/systems.
- Preparation and management of staff records (e.g. job description, CV, introduction plan and training logs).
- Preparation, entering into- and maintenance of third party agreements with stakeholders.
- Training of employees.
- Preparation, hosting of- and follow up on internal/external audits (e.g. business partners) and government inspections.
- Registration, assessment and reporting of unintended incidents, deviations, complaints etc. – incl. root cause analysis and corrective/preventive actions (CAPAs).
- Preparation of risk assessments.
- Monitoring of legal requirements, guidelines etc.
- Liaising with regulatory authorities (e.g. related to registration and reporting).