Laura Reeve - Article Author
By Laura Reeve

Reading and deciphering requirements in a wordy URS can be frustrating and cause complications for OEMs.  Clarke has generated a streamlined URS format that helps eliminate unnecessary words and uses an outline/indented format to present specific requirements. So, how do you adopt this approach to get positive results?

  1. Determine UR Categories

Determine how to categorize your requirements.  It is helpful to have categories that correspond to CQV Testing strategy.  An example of categories that have worked well, listed in order of testing criticality are:

  • Quality Critical: Requirements to release product
  • Process, control and Performance: Parameters to meet Quality Critical requirements and high priority business requirements, such as processing rate. Of course, rate can contribute to quality critical, such as batches that need to be processed within a given time or the lot is in jeopardy.
  • EHS: Safety requirements need to be defined upfront not after the fact
  • Engineering: Client engineering specifications and good engineering practices are included in this section
  • Plant Preferences: Used to indicate preferred vendors for components, etc.
  1. Generate Requirements for Each Section
    • If you have a requirement with multiple specifications, include in one requirement using a general statement such as:

All product contact parts shall be:

a. Material of Construction

  1. 316L SS, Preferred
  2. USP Grade VI Plastic and Elastomers
  3. USP Grade VI Silicones

b. Finish

  1. 20 micro-inch Ra

c. Surface Treatment

  1. Passivation
  2. Electropolished
  • Write each requirement so it is testable. If the requirement is vague and cannot be tested, it needs to be rewritten or deleted.
  • Ensure each requirement is what is needed; do not include how to design it.
  • Do not repeat requirements in multiple categories. This is unnecessary and confusing, especially if the two requirements do not match.
  • Document the reference that the requirement is based on: SOP, USP, good engineering, project specific, etc.
  1. Use for Bidding
    • Consider using the “Reference” column as “Vendor Comments” when including the URS in the bid package.
    • Keeping references in the URS can imply the vendor needs to be meet the entire specification.
    • Keep specifications that are required for bidding out of the URS; include that information in the RFP.

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