Recall the overall objective of product development is to develop the ‘right product’ and to develop the “product right”.  In previous articles, we defined validation as a continuous process throughout product development to establish complete and correct requirements.  Consider the following illustration: 

Valid requirements represent the voice of the customer and acceptability of the product.  Product performance represents the “voice of” the design and process.  Product performance outside of spec limits result in defects and rework (it is not the right product to meet customer needs).

Let’s start with the easiest (and arguably, most likely) scenario:  A product requirement isn’t known with good specificity.  There is pressure to deliver the product to the customer and the customer expects a ‘fully qualified” product.  Some validation doesn’t start until testing in the customers environment. [Read more…]

In a previous article, we covered value stream concepts and characterized the value stream in the context of supply chain major sub-processes.  We covered some important key performance indicators related to order fulfillment.

This article will look at work-in-process (WIP) and inventory using the Supply Chain Operations Reference (SCOR) model. 

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In recent articles we covered value stream concepts and characterized the value stream in the context of supply chain major sub-processes. We summarized the manufacturing value stream according to the following process blocks:

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In two recent articles we covered the management of a contract manufacturer (CM) value stream. We also covered NPI materials management within that model distinguishing NPI materials management from NPI project management.

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This article will cover the management of a contract manufacturer (CM) value stream from the perspective of a company that has outsourced the manufacturing of its product.  A typical CM model is most likely “turn-key” such that the “Company” purchases the only finished goods from the CM. 

Part/component purchases are a shared responsibility between the company and CM.  Company-controlled suppliers have negotiated pricing and purchased orders may be placed by the company or the CM for long-lead and specialty items. 

Ultimately, the liability for part/component inventory rests on the company. For this reason, minimizing inventory, maximizing inventory turns, and value stream flexibility are some major objectives of managing a CM. 

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In Part 1 and Part 2 of this article series, we described validation engineering as the process of validating, monitoring and execution of product requirements to ensure customer needs are met.  The validation engineer is the validation process owner and works with subject matter experts to develop complete, accurate and testable requirements. 

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