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Specifications

Goals

  • Understand how Specifications are used in MES

  • Know how to configure new Spec Types in the Configuration App

  • Know how to add Specifications to a Step

Key Terms

Table 33. 

Term

Definition

Specification

Specifications are important metrics associated with a manufacturing process (Recipe). In L7|ESP, a Specification is a numeric field with:

  1. Spec Type

  2. Min and/or max value

Spec Type

“Spec Type” is a picklist parameter for numeric fields in the Protocol builder. The list of available Spec Types is configured in the Configuration App.

Numeric Field

Refers to a custom field that has Type set to Numbers only allowed.



What are Specifications and when are they used in MES?

Specifications are a way to categorize numeric data being collected. When numeric data is associated with a Specification, then those fields will be tracked in MES. Any Specification field that is recorded during a manufacturing process will be included in the Specification Report of MES’s Reports tab.

Common Specifications (Spec Types) include:

  • CPP – Critical Process Parameter

  • CQA – Critical Quality Attribute

  • KPP – Key Performance Parameter

  • KPI – Key Performance Indicator

  • NCPP – Non-Critical Process Parameter

  • NKPP – Non-Key Process Parameter

How does an End User interact with Specifications in MES?

The Specifications tab provides an overview of the Spec Types defined in the Recipe. Fields listed on this tab have a defined Spec Type and a min and/or max value.

Note

MES does not support hard limits. It instead records out of range values as exceptions, which must be reviewed after the Step is completed.

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The main panel of the tab displays information about the Specifications used or planned within the Batch. This information includes:

  • Step – the Sub-Step that contains the field

  • Spec Type – the defined spec type for the field

  • Description – the name of the field

  • UOM – the unit of measure defined for the field

  • Min – the defined minimum

  • Max – the defined maximum

  • Actual Value – if the field has been entered, the value that was entered

  • Status – an indication of whether the actual value met the limits defined by the minimum and maximum. This column displays a warning icon only if the actual value was out of range.

  • Comment – any comments that were entered for the field

How to configure Spec Types

Before Spec Types can be assigned to a numeric field, they must first be defined in the Configuration App.

To configure a new Spec Type:

  1. Go to Configuration App

  2. Select te esp configuration

  3. Add the name of the new Spec Type under the field_spec_types section of the lims block

  4. Select Restart ESP Services and Save

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How to add Specifications to a Step

Note

Spec Type and Unit of Measure are only supported in MES.

To add a Specification:

  1. Go to Builders (L7|Master) → Protocols → select a Protocol

  2. + Add Field

  3. Select Numbers only allowed as the Type

  4. Expand the Parameters

  5. Select the desired Spec Type from the picklist

  6. Set the desired parameters (optional)

    1. Unit of Measure

    2. Format (None, Percentage, Currency)

    3. Precision Type (None, Decimal places, Significant figures)

    4. Digits

    5. Min Limit

    6. Min Limit Type (Soft, Hard)

    7. Max Limit

    8. Max Limit Type (Soft, Hard)

    9. Notify Group

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Values for numeric fields in MES cannot be formatted, but they can be displayed to a specified number of decimal places or significant figures.

Note

Precision only impacts the displayed value. The underlying value is not changed.

A minimum and maximum limit can be applied to all numeric fields, regardless of format. The acceptable range of values will be displayed to the User in MES. If the User enters a value out of range, a warning message will appear next to the field that says “Out of range”.

Hard limits are treated like soft limits in MES, meaning Users will know if the value is out of range, but they will not be blocked from proceeding. Any fields with out of range values will also appear under the Quality Review tab in MES. To learn more about the Quality Review, check out Operations and Quality Reviewers.

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