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  4. Business Continuity Planning (BCP) - Planning For The Future

Business Continuity Planning (BCP) - Planning For The Future

September 26th, 2019

Author: Krissy Dempsey - Marketing Manager - Saint-Gobain Life Sciences Medical Components

Business Continuity Planning (BCP) is: the process involved in creating a system of prevention and recovery from potential threats to a company. The plan ensures that personnel and assets are protected and are able to function quickly in the event of a disaster.1 From a supply chain perspective, most people associate BCP with obtaining a second source for a given purchased component. However, there is much more to consider to lower your risk of disruption.  Saint-Gobain looks at BCP from risk and probability perspectives allowing us to make recommendations to our customers on ways to reduce risk exposure and increase security of supply.


Materials


Many times we are in such a hurry to get our product ton the market, the idea of validating a second material source is put on the backburner.  But, if we think of the likelihood of our single-sourced raw material having a supply or quality issue, this is an area in which we can reduce risk to supply quite drastically. This does require more work from a testing and a regulatory filing standpoint, which must be evaluated. Outside of a second material source, other methods of reducing material supply risks include executing supply agreements with the raw material vendor as well as holding both raw material and finished goods inventory. Your vendor of choice should be constantly evaluating and validating new raw material suppliers to ensure a strong network of relationships and can provide alternative solutions should raw material constraints arise.


Tooling


With molding and extrusion operations, there is some risk that the tooling used to manufacture the product could be damaged.  This is not uncommon and the probability of some degree of damage, wear, etc. is fairly high.  With that, some strategies to mitigate these risks would include a critical components spare parts list and inventory of those parts.  Redundancies can help as well such as spare cavities or even complete spare tools.


Equipment


Beyond tooling, the supplier’s equipment has risk of failure as well that needs consideration. Redundancies such as duplicate presses, robots and dosing equipment are all options. Cross-validations on other existing equipment is one way to achieve that. A critical components spare parts list and inventory applies to the manufacturing equipment as well as the aforementioned tooling spare parts.


Facility


Most people think secondary source when it comes to backing-up a facility. This is usually because they are thinking of natural disasters that will completely wipe out the operation for an extended period of time. That is certainly one potential way to reduce risk. Another is if your vendor has multiple manufacturing facilities/locations such that you can utilize the same vendor but have cells validated at multiple sites.  If damage is to occur to only a portion of a site, is there continuity planning within the singular site? If your supplier utilizes a modular cleanroom layout, having multiple cells validated in separate cleanrooms can provide risk mitigation should one cleanroom go down while others remain functional.


In addition to the categories mentioned above, when sourcing a component and keeping BCP in mind, always look for a vendor that is established and sustainable with expertise in your area of need. The vendor should also have the knowledge and ability to discuss the various facets of BCP and how you can partner to reduce risks wherever possible.


In summary, BCP can be broken down into a variety of factors with varying levels of risk and probability.  Evaluating the opportunities and choosing what makes the most sense is an exercise that you and your supplier should be able to work together on and jointly reduce the risk of supply disruptions for your product.

1) Kenton, Will, “Business Continuity Planning (BCP).” Investopedia, 1 June 2019, https://www.investopedia.com/terms/b/business-continuity-planning.asp

Please contact us if you have questions on BCP or if you would like to learn more about Saint-Gobain Medical Components capabilities.

Krissy Dempsey - Marketing Manager - Saint-Gobain Life Sciences Medical Components

Krissy Dempsey is the Marketing Manager for Saint-Gobain Life Sciences Medical Components.  She has been with Saint-Gobain’s Medical Components business for over 10 years in various roles. She works closely with sales and applications engineering to support new projects and opportunities, analyzes and develops product strategy and pricing.  She enjoys long walks on the beach and a good laugh every now and again!

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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