Overview




An out-of-the-box workflow of a NCM consists of these steps:

  • Initiate        
  • Evaluation
  • Approval        
  • Closed        

NCM Form Sections

  1. Basic Details Section


Fields

Field Explanation

Parent Process
  • Displays a link to the parent process (If the NCM record was initiated from another module/process)

Title
  • Shall be set based on the Title of the Deviation record

Date of Occurrence
  • Allow selection from a calendar. Set with the current date by default

Type
  • Allow selection from: Finished Product, Incoming Material, In-Process, Manufacturing Rejection, Customer Return

Initiated 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

Priority
  • Allow selection from ‘Low’, ’Medium’ and ‘High’

Description
  • Allow free text entry.

Immediate Actions Performed
  • Allow free text entry.

Attachment
  • Allow user to attach a file.
  1. Scope Section

   


Fields

Field Explanation


  • Allow selection from Customer, Process, Product, Supplier
  1. Evaluation Details Section


Fields

Field Explanation

Conduct Risk Assessment
  • Shall allow user to select whether Risk Assessment is required or not.

Investigation Details
  • Allow free text entry.

Attachment
  • Allow user to attach a file.

NCM Occurred Before?
  • Allow user to select whether NCMs have occurred previously or not.

Previous NCMs
  • Allow selection from previously closed NCMS if ‘NCM Occurred Before?’ is set. 

CAPA Required?
  • Allow the user to select whether a CAPA is required or not.
  1. Disposition Details Section



Fields

Field Explanation

Disposition
  • Allow selection from: Other, Recall from marketplace, Reject – Destroy, Reject - Return to Supplier, Reprocess, Rework, Use as is, Use with Concession(s)

Deviation Required?
  • Allow the user to select whether a Deviation is required or not.

CREATE ACTION
  • When clicked creates a new User Action in a dialog

Rationale for Decision
  • Allow free text entry.
  1. Cost Section



Field

Field Explanation

Item
  • A free text field allowing inputting the name of the item

Cost
  • Allow inputting the numerical value, which is the price of the corresponding item.


  1. Effectiveness Check Section



Field

Field Explanation

NCM Implemented successfully?
  • Allow to select whether NCM has been implemented successfully or not. 

Comments
  • Free text entry.