Quality
DHL Supply Chain’s Life Sciences and Healthcare sector recognises quality assurance is key to its business strategy, customer satisfaction and demonstrating best in class.
DHL’s Life Sciences and Healthcare sites globally operate to current regulations:
• Good Distribution Practice (GDP) eg WHO and EU GDP 94/C 63/03
• Good Manufacturing Practice (GMP) eg ICH Q7, ICH Q10, EU GMP
• Good Clinical Practice (GCP) eg ICH E6 and EU GMP annex 13
• Good Automated Manufacturing Practice (GAMP) guidelines covering IT system and building validation
• Food & Drug Administration (FDA) code such as 21CFR Part 11 (for electronic signatures and records), 21 CFR 820 (Quality System Regulation), 21 CFR 211 (GMP for finished pharmaceuticals) and 21 CFR 600 (Biological products)
• Regional internal audit process as part of GDP / GMP compliance and to ensure approach to 6C’s
• EFQM self assessment process is a component of our healthcare quality strategy.
Here are some questions and answers that are frequently asked regarding Quality. We hope you find them helpful and informative. If at any point you don't find the answer to your questions, please Contact Us
- What is healthcare quality all about?
- How do you maintain quality across sites?
- How do you pull together the regulations into an internal standard?
- How do you plan internal audits?
- How often do Customers audit?
- How do you communicate quality standards internally?
- Does quality play a role in your training programme?
- Is quality involved in the monitoring of KPI's?
- How do you share best practice?
- How do you manage licencing requirements?
- How do you manage corrective actions and ensure closure?
- How does DHL Supply Chain manage customer complaints?
- Which industry bodies do you participate in?
- How do you incorporate innovation into quality?
- How do you ensure supply chain temperature compliance?
Are your questions left unanswered? Please Contact Us
What is healthcare quality all about?
Healthcare quality is important to all aspects of the life sciences industry which includes Pharmaceutical, Biotech, Medical Device and Medical Equipment manufacturers as well as Health Services and Hospitals. Healthcare quality incorporates both quality and control to ensure patient safety, product integrity and regulatory compliance. Each area of the life sciences industry will have varying quality requirements and DHL Supply Chain need to be aware of these requirements and our aim is to exceed them. Quality within DHL is not designed to meet ISO standards but incorporate Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). It is important to understand that Quality Control is about taking samples and checking and Quality Assurance is about leading a team through processes and procedures and is more operational.
Back to TopHow do you maintain quality across sites?
DHL Supply Chain uses various tools to benchmark their operations. The Global Quality team has produced a number of GDP quality posters in multiple languages to communicate key Quality messages. In addition, audits are carried out at various levels to ensure consistency and best practice sharing. Each site has fully trained auditors who will audit their own site but also audit other DHL Supply Chain sites to promote consistent operations across geographies. ISO 9001:2008 and ISO 13485:2003 standards are adhered to during this process. DHL's First Choice programme promotes global standards at a country level. Customers will also audit sites periodically.
Back to TopHow do you pull together the regulations into an internal standard?
DHL Supply Chain has published "Rules and Guidance - GxP guidelines for handling biological medical devices and pharmaceutical products within contact logistics operations". We refer to this as our "Yellow Book" which signposts regulation and guidelines pertinent to the supply chain environment. The Yellow book is updated on an annual basis. DHL Supply Chain incorporates many sources of standards into our EMEA Quality Database in order that they can be referenced. For example For Europe we use European GDP laws but also incorporate the EU directives that allow the regulations to be changed slightly depending upon the country, therefore we incorporate country rules into the mix. We also link with WHO and ICH.
Back to TopHow do you plan internal audits?
We have a Global Quality Team who will plan the required audits 6 months in advance. It is a requirement of ISO 9001 and ISO13485 to audit all of our processes. DHL Supply Chain also audit in line with GDP and GMP requirements.
Back to TopHow often do Customers audit?
Customers will generally audit twice per year, on a multi-user site there may be as many as 1 audit per week. Customers will often separate the audits into to specific functional areas for example a pharmaceutical audit, a systems audit or a security audit. Occasionally we will subcontract audits to Chemists or IATA (if an air freight audit) to assist DHL. Each site has a dedicated quality resource to ensure compliance with GDP / GMP requirements.
Back to TopHow do you communicate quality standards internally?
We maintain an in depth Global Quality Database into which we feed all updates of information relating to directives, changes in standards and quality audit reports for each site. We gather information from the Journal of Medical Device Regulations and GS1 Bar Code Standards. Each country has a link to regulatory bodies and as a sector we are members of International Society for Pharma Engineering and we work closely with bodies to validate systems such as MHRA and FDA.
Back to TopDoes quality play a role in your training programme?
Training is compulsory for all new staff for GDP and GMP. Individual sites update their training programmes regularly to ensure changes in standards are cascaded. We also train quality resources to 6 sigma standards. The importance of quality is also included in our Healthcare modular training programme where examples of best practice are demonstrated and the risks and consequences of poor practice are discussed.
Back to TopIs quality involved in the monitoring of KPI's?
DHL's First Choice programme has 12 corporate metrics that are monitored and reported. Patient safety is paramount when setting KPI's. DHL do not look at averages but at variations, we review standard deviation not the mean and we use quality tools and processes to ensure accuracy of reporting. Measurement of KPI's is supported through Non-conformance Reports, CAPAs and Capability Reporting.
Back to TopHow do you share best practice?
Audits are carried out at various levels to ensure consistency and best practice sharing. Each site has fully trained auditors who will audit their own site but also audit other DHL Supply Chain sites to promote consistent operations across geographies. ISO 9001:2008 standards are adhered to during this process. DHL's First Choice programme promotes global standards at a country level. Customers will also provide presentations on their requirements for updated best practice.
Back to TopHow do you manage licencing requirements?
Within an existing operation the Quality Manager (qualified person/ responsible person) will manage this process, in some countries there may be a requirement to apply to different bodies for licencing for human medication and animal medication. Many regulations are managed by different bodies i.e. Import, Controlled Drugs, Manufacturing etc. New country sites are supported by the Healthcare sector team until they are established.
Back to TopHow do you manage corrective actions and ensure closure?
All Corrective Action and Preventative Actions (CAPAs) are entered into a Quality Database, there is a standard format for these reports. The CAPAs are managed at a country level and all actions are audited to ensure correction. The CAPAs are also incorporated into the training programme as they are a valuable learning reference tool.
Back to TopHow does DHL Supply Chain manage customer complaints?
We have a Healthcare Customer Services tool. Each complaint is given a unique reference number and customers submit their complaint together with any relevant documentation into this system using their unique number. This system is linked to our Warehouse Management System, KPI's and Management Information Systems, all of which allow us to monitor how long the complaint is taking to rectify. The tool can provide the quality team with statistics and will also list corrective actions. Feedback is also given to the customer and details of closure are confirmed.
Back to TopWhich industry bodies do you participate in?
ISPE, GS1 Healthcare, HBPI, PDA, PDIG, EFQM, EDQM, IATA, TAPA, RAPS, TOPRA, CILT to name but a few. We are also members of transport bodies and have close links with PCT's and the NHS.
Back to TopHow do you incorporate innovation into quality?
We work closely with GS1 on projects that require testing, we also attend conferences and trade fairs. As members of a variety of bodies we can keep up to date with new opportunities for innovation and continuous improvement (CI). Our CI programme is based around 6 sigma methodology and processes.We like to work with customers and suppliers to understand their requirements but also to look deeper at the need behind the requirement to innovate.We also work with various bodies to validate improvements and ideas.
Back to TopHow do you ensure supply chain temperature compliance?
We use vigorous testing to validate the complete supply chain. Validated systems are used for monitoring including temp tales, freeze tags, time strip etc. We will also use temperature probes on dummy runs using expired product. We also validate our DHL Fleet. We use a combination of a validated supply chain plus continuous monitoring.
Quality in practice
• Global quality structure and quality policy in conjunction with the customer.
• Sharing of best practice and continuous improvement.
• Sites approved and licensed by the relevant national regulatory agencies (e.g. MHRA in UK, IMB in Ireland, BfArM in Germany, Infarmed in Portugal, IGZ in the Netherlands, Anvisa in Brazil, FDA in the USA, HSA in Singapore, TGA in Australia...).
• Staff trained to Good Distribution / Manufacturing Practice (cGXP) standards.
• Health and Safety (e.g. Royal Society for the Prevention of Accidents (RoSPA) Gold Award 2009).
• Staff security checks / five year employment history.
• Standardised process for Corrective and Preventative Action (CAPA’s), deviations and quality reports (complaints and incident reporting and resolution).
UK Licenses and Standards
- MHRA Wholesalers Dealer License
- MHRA Manufacturer’s/Importers License
- MHRA IMP License
- MHRA Manufacturer’s “Specials” License
- MHRA Manufacturer's "Assembly Only" License
- MHRA Manufacturer's Veterinary License
- Home Office controlled drugs licenses to handle schedules 2 to 5
- GAMP 5 Systems Validation
- ISO 9001: 2008 Certified
- Clinical trials audited to GMP Annexe 13 standards
- FDA audited
