Our Quality Assurance Services
We can help
At Rubicon Technical, we understand the complexity and challenges that come with quality assurance activities. That’s why our team of experts are dedicated to providing efficient solutions for your quality management systems.
With extensive knowledge in regulations and processes, we can assist you in navigating through the intricacies of quality with regulatory compliance.
We can help with:
Quality Assurance and QC Support
Rubicon specialises in Quality Assurance and Quality Management Systems for businesses in nutrition, cosmetics, medical devices, and medicines sectors. Our expert consultants guide you through ISO standards and UK regulations, helping you implement and maintain robust QA and QMS processes.
Quality Support Across Sectors
We help comply with standards like GFSI and ISO, and UK & EU regulations. Our team ensures your products are safe, effective, and compliant with all relevant guidelines.
Cosmetics
We support adherence to ISO standards like ISO 22716:2007 (Cosmetic Good Manufacturing Practices) and UK regulations, including The Cosmetic Products Enforcement Regulations 2013 and The EU Cosmetic Products Regulation (EC) No. 1223/2009. We guarantee your cosmetic products are of the highest quality and safe for consumers.
Medical Devices
We help navigate ISO standards like ISO 13485:2016 (Medical Devices Quality Management Systems) and regulations, including the UK’s Medical Devices Regulations 2002, EU Exit Regulations 2019, and the EU’s MDR 2017/745. Our expertise ensures your medical devices meet standards, comply with regulations, and perform optimally.
Medicines
We provide support in adhering to regulations like The Human Medicines Regulations and GMP Directives. Our consultants guarantee your medicines are safe, effective, and compliant.
UK/EU QP & RP Services
At Rubicon we understand the challenges MIA holders and WDA(H) licensees face in maintaining compliance with evolving regulations. Our experienced team has a deep understanding of the pharmaceutical industry and WDA(H) regulations, ensuring your
business stays compliant.
Comprehensive Service
Our Responsible Person services include:
- Compliance with GDP and GMP guidelines
- Management of product recalls and quality issues
- Maintenance of records and documentation
- Monitoring storage, transport, and distribution
- Liaising with regulatory authorities and inspections
- Implementing risk management and continuous improvement
Proactive Approach to Compliance
We anticipate potential issues and implement preventative measures to safeguard your business. By partnering with Rubicon, you can focus on core operations while we handle quality and regulatory compliance.
Auditing
In today’s competitive market, compliance with industry standards is crucial. Here at Rubicon we provide exceptional auditing services for internal and external needs, covering GMP, BRC, ISO, and GDP.
Comprehensive Auditing Solutions
We offer a suite of auditing services tailored to your specific needs:
Internal Auditing – Our experienced auditors evaluate your organization’s processes, systems, and documentation to ensure adherence to relevant standards, identifying any non-compliance or potential risks.
External Auditing – We conduct audits with third-party suppliers and partners, ensuring they meet quality and compliance standards, and assist in preparing for external audits by certification bodies or regulatory authorities.
Expertise Across Key Industry Standards
Our auditing services cover a wide range of industry standards:
GMP Auditing – Our expert auditors ensure your manufacturing processes, quality control systems, and documentation comply with GMP requirements for pharmaceutical, food, and cosmetic industries.
BRC Auditing – We help you achieve and maintain BRC certification, ensuring manufacturers and suppliers in the food and packaging industries meet the highest levels of quality and safety.
ISO Auditing – Our auditors are well-versed in ISO standards, including ISO 9001, ISO 14001, and ISO 27001, helping you implement and maintain effective management systems that meet international standards.
GDP Auditing – We ensure your supply chain maintains the necessary levels of quality, safety, and security for the storage and distribution of pharmaceutical products.
Our Quality Team
Jo Knowles
Quality Manager
Dainis Vitols
Quality Coordinator
Nicholas Parkin
HACCP, TACCP and VACCP Certifications
At Rubicon Technical, we pride ourselves on providing top-quality services to our clients. We understand the importance of product safety and maintaining high standards in your supply chain. That’s why we offer HACCP (Hazard Analysis and Critical Control Points), VACCP (Vulnerability Assessment and Critical Control Points), and TACCP (Threat Assessment and Critical Control Points) quality services.
HACCP:
HACCP, or Hazard Analysis and Critical Control Points, is a globally recognised methodology for ensuring the safety of food products. It is a systematic and preventive approach that identifies and mitigates potential hazards in the production, processing, packaging, and distribution of food products. By implementing a HACCP plan, food businesses can effectively manage and control food safety hazards, resulting in safe and high-quality products.
At Rubicon, we offer a range of HACCP services, including study writing, review, and certification, to help businesses meet their food safety obligations. Our team of experts work with businesses to develop customised HACCP plans that meet international standards and comply with local regulations. Our comprehensive services involve identifying potential hazards, control measures, and critical control points in the food production process to ensure maximum safety and quality.
TACCP:
TACCP is a critical element of food safety management, and specifically addresses the risks that arise from a deliberate and malicious act such as contamination, adulteration, and tampering. TACCP stands for Threat Assessment and Critical Control Points, and it is a preventative and proactive approach to ensure the safety and security of your food products.
At Rubicon, we offer a range of TACCP services to help businesses identify and manage food safety risks caused by malicious intent. Our team of experts will conduct a thorough and comprehensive risk assessment to identify potential threats to your food products. We will then design and implement a customised TACCP plan unique to your business that incorporates critical control points to help mitigate those risks.
VACCP:
VACCP, or Vulnerability Assessment and Critical Control Points, is a key element of food safety management, and specifically addresses the risks that arise from intentional and economically motivated adulteration. In today’s increasingly complex food supply chain, businesses face significant risks of food fraud, and VACCP is an essential tool to manage those risks.
At Rubicon, we offer a range of VACCP services to help businesses identify and manage the risks of food fraud. Our team of experts will conduct a comprehensive vulnerability assessment to identify and prioritise the most significant risks. We will then work with your business to design and implement a customised VACCP plan that incorporates critical control points to help mitigate those risks.
Our HACCP, TACCP and VACCP services are compliant with ISO standards and other globally recognised references, ensuring maximum safety and security for your products.
Risk Assessment and Management
At Rubicon we know managing risks is crucial for success in the food supplement, medicines, and medical devices industries. Our expert team provides unparalleled risk assessment and management support using a wide range of ISO standards and techniques.
Comprehensive Risk Assessment
Our services identify and evaluate potential hazards in your products or processes. We use established techniques described in ISO 31000:2018, ISO 14971 and HACCP methodology to ensure safe and efficient operations.
Thorough Hazard Identification
We examine your products and processes to pinpoint potential risks, including raw materials, manufacturing, packaging, storage, and distribution.
Quantitative Risk Evaluation
Using quantitative techniques we analyse and prioritize risks, allowing you to focus on critical hazards and allocate resources efficiently.
Proactive Risk Management
Our services help you stay ahead by implementing effective risk mitigation strategies. We develop tailored risk management plans based on the ISO 31000:2018 (Risk Management), ISO 14971:2019 (Medical Devices – Application of Risk Management), ISO 13485:2016 (Medical Devices – Quality Management Systems), ICH Q9 (Quality Risk Management in Medicines), and HACCP (Hazard Analysis and Critical Control Points) methodology.
Risk Mitigation Strategies
We collaborate with your team to create practical and cost-effective mitigation strategies, such as process improvements, procedure updates, or employee training.
Ongoing Risk Monitoring
We understand risks change over time, so our ongoing monitoring ensures your plan remains current and effective. We also support compliance with relevant regulations and standards as your business evolves.
Quality Management Services
At Rubicon we are committed to offering outstanding third-party quality management services tailored for the nutrition industry. Our experienced team of professionals guarantee that your company’s Quality Management System and products comply meet best industry standards.
Comprehensive Quality Management Services
We specialise in a diverse range of quality management services, including:
- Auditing and assessment of your current systems
- Implementation and administration of robust Quality Management Systems (QMS)
- Regulatory compliance and certification assistance
- Continuous improvement initiatives
- Document lifecycle management for streamlined processes
- QA batch release of products to market
Quality Improvement Project Management
Our team at Rubicon know quality and regulatory compliance are crucial in today’s market. Each one of experts is committed to helping your organization navigate quality improvement and regulatory requirements with customised solutions..
Comprehensive Support for Quality Improvement
Rubicon provides end-to-end support to help your organisation achieve its goals while maintaining top quality and compliance. Our services focus on continuous quality improvement processes covering:
1. Project planning and scoping
2. Process mapping and optimization
3. Risk assessment and mitigation
4. Regulatory guidance and compliance
5. Training and education
Tools and Techniques
We employ proven tools and techniques in our quality improvement projects, including:
- Lean Six Sigma
- Root Cause Analysis
- Statistical Process Control
- Failure Modes and Effects Analysis (FMEA)
- Change Management
These are just a few of the services we can provide for your quality assurance needs, get in touch with us today.
Contact Us:
Need our help? Get in touch today to see which of our services is most suitable for your quality needs.
Rubicon Technical UK
C4DI @ The Dock, 31-38 Queen Street, Hull, HU1 1UU
Email: info@rubicontechnical.co.uk
Call us: 01482 702726
Rubicon Technical Netherlands
Keizersgracht 555, Amsterdam, 1017 DR,
Netherlands
Email: info@rubicontechnical.nl
Call us: +31 20 3085473