{"id":1492,"date":"2020-01-21T02:34:00","date_gmt":"2020-01-21T07:34:00","guid":{"rendered":"http:\/\/www.spartasystems.com\/?post_type=resources&p=1492"},"modified":"2024-08-13T10:57:30","modified_gmt":"2024-08-13T14:57:30","slug":"protect-your-product-from-the-risks-of-supply-chain-complexity","status":"publish","type":"resources","link":"https:\/\/www.spartasystems.com\/resources\/protect-your-product-from-the-risks-of-supply-chain-complexity\/","title":{"rendered":"Protect Your Product From the Risks of Supply Chain Complexity"},"content":{"rendered":"\n

Proactive quality management requires complete visibility into quality\u2014which includes your entire supply chain<\/h2>\n\n\n\n

If reducing the risk of recalls is one of your top priorities in 2020, then proactive quality management<\/a> is a natural fit. <\/p>\n\n\n\n

Visibility and collaboration are an integral part of a proactive approach, which is challenging when it comes to the supply chain. <\/p>\n\n\n\n

Outsourcing, multiple sites and other issues add a level of complexity that can hinder your quality management efforts and increase recall risks. <\/p>\n\n\n\n

What can you do?<\/p>\n\n\n\n

The High Cost of Quality Events<\/h3>\n\n\n\n

Recalls are a potentially disastrous\u2014and increasingly common\u2014outcome of quality events. <\/p>\n\n\n\n

From 2004 to 2013, FDA drug recalls increased 600 percent. Stericycle Expert Solutions reported that more than one million Class 1 medical device units were recalled<\/a> in Q1 of 2019 alone. The report cited quality issues as cause of the recall in more than half those units.

A single recall can easily cost your company tens of millions of dollars, not to mention long-term detrimental effects on sales, brand image, and company value. <\/p>\n\n\n\n

Major quality events can cost hundreds of thousands of dollars per day and can take weeks-to-months to resolve. <\/p>\n\n\n\n

Even a spike in temperature or humidity in a controlled manufacturing environment can shut down manufacturing at the site of the event until the problem is resolved.

Increasing the number of hand-offs from raw material to finished product increases your risk of a quality event. <\/p>\n\n\n\n

But regulations are clear that the product owner is ultimately responsible for any quality issues, even those that originate with suppliers. <\/p>\n\n\n\n

In ICH Q10 (Pharmaceutical Quality System), the FDA states that pharmaceutical companies are \u201cultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials.\u201d <\/p>\n\n\n\n

Manufacturers must find ways to manage supplier risk if they hope to control their own.<\/p>\n\n\n\n

Increased Complexity = Increased Risk<\/h3>\n\n\n\n

Current Good Manufacturing Practice (CGMP)<\/a> requires robust quality management systems that can keep up with today\u2019s exacting quality standards. <\/p>\n\n\n\n

Yet the quality systems in place at suppliers and smaller contract manufacturing organizations often fail to meet these standards.

A 2018 report in BMJ Global Health<\/em><\/a> noted that inadequate quality systems play a primary role in quality issues across pharmaceutical supply systems in low-income and middle-income countries. <\/p>\n\n\n\n

The report stated that \u201cthe variability of the quality systems across distributors in a country implies a variable level of QA, and a real risk of exposure to poor-quality or degraded medicines.\u201d

Even under the best circumstances, the use of separate quality systems at suppliers or contract manufacturers increases complexity and can limit your visibility into end-to-end quality. <\/p>\n\n\n\n

Issues that stem from supply chain complexity typically involve five factors:<\/p>\n\n\n\n