Definitions

Quality Requirements and Specifications

Quality Requirements and Specifications (aka QRS) is a document that specifically defines the criteria that items must meet to ensure their safety, quality, and compliance with relevant regulations, standards or customer requirements. It can define some grading tolerance, acceptable countries of origin, temperature check, etc…

Quality Requirements and Specifications can be of type Purchase (for inbound flows) or type Sales (for outbound flows). It should be attached to a specific vendor or customer to be applicable on the related purchase or sales documents.

QRS Documents Lines

There are some business scenario’s where the Quality Requirements and Specifications may need to be ajusted on document level (example: for a specific Sales Blanket Order, customer defines specific requirements.). To support those scenario’s the Quality Requirements and Specifications defined at Customer/Vendor levels are transported to the sales/purchase document. If User is authrorised (having at list QRS - Admin rights) he can then adjust the requirements at document level.

Deviations

Deviations are departures from the specified quality standards (defined in Quality Requirements and Specifications). They can be intentional or unintentional, and they can be identified in the inbound or outbound processes. Deviations can have an impact or potential impact on product quality, GMP regulated systems, or regulatory filings. Therefore, they need to be handled and managed properly and when stated should be recorded using Deviation Entries.

Inspection Status

An Inspection Status defines if a lot is available for specific types of transaction. For example, a lot can be available for production depending of its inspection status, but not for sales. So basically, an inspection status will define which transaction will be possible or blocked for a specific lot. To use Inspection Status in combination with Quality Requirements and Specifications the inspection status app must be installed first.

Minimum Shelf Life

The Minimum Shelf Life is a date formula field. It can be defined on the purchase or sales side. When registering and inbound/outbound transaction, a check will be done that the minimum Minimum Shelf Life is respected. If the registered lot Expiration Date does not match the minimum shelf life, then this will be identified as a possible deviation.

Minimum Shelf Life check is only possible for items having a Tracking Code with Use Expiration Date or Require Expiration Date toggles enabled.

Sell by Date

Date marked on a perishable product indicating the recommended time by which it should be sold. The Sell by Date is calculated per lot as follows: Lot’s Expiration Date – item’s Sales Minimum Shelf Life = lot’s Sell-By Date. This is an informational field used to identified lots that are closed to be expired not matching Sales Minimum Shelf Life requirement.

Source and Demand Attributes

The Source and Demand Attributes are both Advanced Attributes of type Promoted. Those attributes must be setup first prior starting to create Quality Requirements and Specifications (see Advanced Attributes Management Setup).

They will be considered as Source Attributes when being used on a purchase (inbound) process and Demand Attributes when used on a sales (outbound) process.

Those attributes will be used to check that a specific lot is matching the Quality Requirements and Specifications defined for the specific vendor/customer. For example, lots from a country of origin can’t be sold to a specific customer.