Momentum QMS Help

Fields

Field Explanation

Description

• Allow free text entry

Number

• Automatically generated with the following format: DEV-XXXXX where XXXXX is the next sequential number

Date of Occurrence

• Allow selection of a Date. The current date shall be seeded by default.

Reported By

• Allow selection from all users in the system. 
  
  
• Set with the current user by default

Department

• Allow selection from: Administration, Customer Service, Human Resources, IT, Manufacturing, Marketing, Quality, Sales

Category

• Allow selection from: Batch/Packaging Record, Calibration, Computer systems, Environmental, Equipment , Function/Facility Issues, Incoming Materials, Material Status, Other, Out Of Specification, Process Control Parameters, SOP/SOI/SPI/Procedures, Sampling, Testing, Use of Documents.
• If this Deviation was created from a Calibration record then set ‘Calibration’ by default.

Attachment

• Allow user to attach a file.

Fields

Field Explanation

Did this issue cause operational disruption?

• Allow selection from "Yes" or "No".

Immediate Actions Performed

• Allow free text entry.

Fields

Field Explanation

• Shall allow user to select from these options Customer, Equipment/Instrument, Process/Operation, Product, Supplier

Fields

Field Explanation

Conduct Risk Assessment?

• Shall allow user to select whether risk assessment is required or not.

Has this issue occurred before?

• Allow selection from "Yes" or "No"

Previous Issues

• Allows selection from all Closed Deviations if ‘Has this issue occurred before?’ is set to ‘Yes’.

Root cause investigation required?

• Allow selection from ‘Yes’ or ‘No’. Visible if Scope does not contain ‘Product’

Field

Field Explanation

CREATE ACTION

• When clicked allow create an action for the Issue.

Notes

• Allow free text entry.

Field

Field Explanation

Equipment Lookup

• When clicked allow create an action for the Issue.

Equipment Name

• Shall allow selection from a list of Equipment in the system. When a Equipment is selected in the Equipment Lookup then the Equipment Name, Equipment Number, Status, Location of the Equipment shall be seeded in the corresponding fields of the section.
• If this Deviation was created from a Calibration record then set a Link to the Equipment being Calibrated by default.

Equipment Number

• Allow free text entry. If this Deviation was created from a Calibration record then set the value of the ‘Equipment’ field (Equipment Number) from the Calibration by default.

Status

• Allow free text entry.

Location

• Allow free text entry.

Other Details

• Allow free text entry.

Field

Field Explanation

Customer Lookup

• Shall allow selection from a list of Customers in the system. When a Customer is selected in the Customer Lookup then the Name, Contact Name, Email, Phone of the Customer shall be seeded in the corresponding fields of the section.

Name

• Allow free text entry.

Contact Name

• Allow free text entry.

Email

• Allow free text entry.

Phone

• Allow free text entry.

Other Details

• Allow free text entry.

Field

Field Explanation

Supplier Lookup

• Shall allow selection from a list of Suppliers in the system. When a Supplier is selected in the Supplier Lookup then the Business Name, Contact Name, Email, Phone of the Supplier shall be seeded in the corresponding fields of the section.

Contact Name

• Allow free text entry.

Email

• Allow free text entry.

Phone 

• Allow free text entry.

Other Details

• Allow free text entry.

Field

Field Explanation

Product Lookup

• Shall allow selection from a list of Products in the system. When a Product is selected in the Product Lookup then the Number, Name, Version, Location of the Product shall be seeded in the corresponding fields of the section.

Number

• Allow free text entry.

Name

• Allow free text entry.

Version

• Allow free text entry.

Location

• Allow free text entry.

Batch Number

• Allow free text entry.

Lot Number

• Allow free text entry.

Manufacturing Date

• Allow selection from dialog

Other Details

• Allow free text entry.

Field

Field Explanation

Process Name

• Allow free text entry.

Stage/Step

• Allow free text entry.

Related Procedure

• Allows selection from all approved documents in the system