Corporate Social Responsibility: Product Quality and Patient Safety

We work hard to deliver the safest medical and pharmaceutical products to the patients who count on us.

We deliver one-third of prescription medicine in North America, and we serve more than 2 million customers every day in Europe. It’s crucial to deliver the safest products to all of these patients, because both the people making the medicine and the people taking it count on us.

Responding to the opioid epidemic in the U.S.

Each day, our distribution team delivers life-saving medicines to pharmacies, hospitals and clinics that serve millions of Americans. We take to heart that at the end of each and every item delivered – every pill bottle, every vial, every ointment – there is a patient in need. We know that it’s not just a package, it’s a patient.

Over the past decade, as the opioid epidemic evolved rapidly, we enhanced our teams, processes and technologies dedicated to preventing diversion. We are committed to maintaining – and continuously enhancing – strong programs designed to detect and prevent opioid diversion within the pharmaceutical supply chain, while also protecting the availability of appropriate treatments for patients with serious illnesses and injuries.

This complicated, multi-faceted public health crisis must be addressed through a comprehensive and collaborative approach. Each participant in the pharmaceutical supply chain can play an important role.

We have advanced a series of company initiatives focused on helping to address the opioid epidemic, including launching a foundation dedicated to combating the crisis, offering thoughtful public policy recommendations – including the Prescription Safety-Alert System (RxSAS) technology proposal – and supporting innovative programs and partnerships that we believe can have a meaningful impact on this challenging issue. We are committed to engaging with all who share our dedication to acting with urgency to address this epidemic and working together to end this national crisis.

McKesson Supply Chain infographic: Manuracturer to Transportation to Distribution Center to Transportation to Hospital/Pharmacy to Customer/PatientEnsuring products are safe and high quality

Our quality management system is based on international procedures to ensure that products we handle and distribute, as well as the products we manufacture in our private-label line of business, follow applicable regulations:

  • Compliance: We comply with applicable laws and regulations concerning product quality in the countries where we do business. These include the Drug Supply Chain Security Act in the U.S., the Food and Drugs Act in Canada, and the Good Distribution Practice and Good Manufacturing Practice guidelines in Europe.
    These laws and regulations commit us to keeping our products traceable, handling hazardous products appropriately and continuing to work with authorized trading partners.
  • Product integrity: Our supply chain security, safety and security-training programs focus on the integrity of product packaging and containers. Here’s how:
    • When receiving products, we verify the quantity, supplier name and product name through the purchase order. We also make sure that the product is not set to expire soon. Our tracking system automatically lets us know if a supply is affected by a recall.
    • When shipping products, we use containers that maintain quality and safety and ensure appropriate temperature control. Refrigeration experts ensure we select shipping containers that comply with manufacturers’ product specifications. When we use passive cold chain solutions, we require containers to pass a qualification process. This helps guarantee product integrity and prevent any quality issues.
    • When potential incidents happen, we work to respond promptly. We follow a Corrective Action – Preventive Action (CAPA) process. To prevent counterfeit products from entering the legal distribution network, we follow a supplier qualification procedure for vendors. As part of this process, we perform regular audits and checks of authorizations and certifications.
    • During product recalls, we reach out to pharmacies and other customers with details on the recall and how products can be returned to McKesson. We continuously train our customer service employees so they are up-to-date on current recalls.
  • Traceability: In Europe, we follow the Falsified Medicines Directive, which requires batch tracking of certain medicinal products. When products enter the warehouse, we record the product code, expiration date and batch number. Using handheld terminals, we track the product at every stage of its journey in the warehouse—from replenishment, to picking, to returns. If an inaccuracy occurs, the tracking system generates an alert. Our quality coordinators monitor the alerts and resolve any inconsistencies.
  • Supplier requirements: Just as we hold ourselves accountable, we also hold our suppliers accountable for the quality of their products and services. In areas where we outsource distribution, this includes contracted carriers and couriers.
    In the U.S., Canada and Europe, suppliers meet our requirements through compliance with regional, national and international legislation. For other regions, please see “Responsible sourcing” below.
  • Manufacturer requirements: We comply with manufacturer requirements for handling and distributing products. In some cases, we have contracts with manufacturers that restrict the sale of certain medicines to certain customers, such as prison systems and others, for lethal injections. McKesson is committed to helping manufacturers implement their policies in this area. The needs and requirements of various manufacturers are different, so our contractual commitments, controls and processes vary by manufacturer. McKesson has processes and systems to enable manufacturers to validate our performance against our contractual arrangements.
    When we manage quality, our guide isn’t only laws and regulations but also best practices and international standards. For example, 10 of our businesses in Europe are ISO 9001 certified. ISO 9001 is an international standard for quality management systems.

Responsible sourcing

We work with private-label suppliers outside the U.S., Canada and the European Union. Those suppliers must agree to the McKesson Sustainable Supply Chain Principles (MSSP). The MSSP covers compliance with appropriate laws along with adherence to our strict policies on protecting workers, preparing for emergencies, identifying and managing environmental risk, and protecting the environment. These principles reflect our stance against forced and child labor, which we articulate in our response to the UK Modern Slavery Act.

In the U.S. and Canada, before we place the first order with a new supplier, we conduct desktop or on-site audits depending on a risk matrix analysis. These audits cover all MSSP areas. On-site audits include document review, a factory tour and interviews with workers. In either case, we document the findings and require a corrective action plan for any instances of non-compliance.

Adherence by suppliers to MSSP is not optional. McKesson Global Procurement & Sourcing Limited (MGPSL) is stringent in regard to remediation efforts. These are made by suppliers when audits reveal any gaps in working conditions, health and safety, or environmental standards. To maintain high sustainable principles standards in factories we purchase products from, we follow up periodically on initial audits and closely monitor corrective actions.

When issues are identified, McKesson auditors work with the supplier to ensure improvements are made. These audits include interviews with workers and management, inspections of production sites, and document reviews. Audit findings or non-conformances are prioritized based on risk. Should a critical issue be identified, MGSPL would require a timely response from the supplier. If a supplier failed to adequately remediate the issue, the relationships would be re-evaluated and, if necessary, terminated.

Quality improvement through Six Sigma

Across McKesson, we strive to continuously improve by using Six Sigma. Six Sigma helps us work better by using data to drive decision making and promote continuous quality improvement across our company. Using problem-solving tools, Six Sigma reduces defects and minimizes variances.

By improving processes, we can see fewer errors, faster cycle time and less waste.

In FY19, McKesson completed 405 Six Sigma projects, which had more than $160 million in cost savings and avoidance across our company, suppliers and customers.

One of Six Sigma’s key objectives is to train, coach, and mentor employee talent, in order to deepen the operational excellence culture across McKesson. In FY19, employees in the countries covered by our centralized learning management system completed 1,269 Six Sigma training courses.

Here are a few of our Six Sigma projects:

  • Driving enhanced value through the supply chain: In FY19, the U.S. Six Sigma team completed five customer and supplier engagements that focused on the supply chain, from enhancing communication with the customers and suppliers to increasing service level metrics and improving cycle time for resolution of open items.
  • Reducing paper by going digital: In 2018, a Lean Six Sigma Team Green Belt project paved the way into the digital future. When medicines are delivered, there are a number of documents that must be printed out and enclosed with the delivery to fulfill official requirements. The Portuguese colleagues challenged those requirements to make a step towards the future. The idea: saving paper consumed by digitizing the documents. In order to get the green light for this desired change, the project team closely collaborated with the Portuguese legal authorities. Although the official requirements initially stated printed versions, the Portuguese team reached agreement with the authorities on how to digitize this step, fulfilling the legal obligation concerning transport documents. This LSS initiative has a positive impact on the company’s carbon footprint as well as pharmacies, who now have less paper waste.
  • Tracking to better control precursor returns: Precursors are products with active pharmaceutical ingredients that can be used to make illegal drugs, such as methamphetamine. As part of McKesson Canada’s commitment to Health Canada, Six Sigma led a team to create an automated tracking system. It provides visibility along each step of a precursor return—from when the product is created and shipped to the customer to when the physical return comes back into the McKesson building for processing.

These are just a few of our Six Sigma successes. Whether it’s reducing defects or streamlining processes, we look forward to tackling additional projects in FY20 and beyond.

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