QMS Audit Observation

Introduction

The purpose of a QMS audit is to ensure your company has established the appropriate processes and procedures within your quality management system (QMS), and that those processes and procedures are being followed. I know a lot of people dread audits, but they're simply a fact of life in the medical device industry.

Tab

Tab

QMS Audit Observation

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Critical Fields :

  1. Document No : Individual Identity of the record, It is an unique value
  2. QMS Audit Schedule : This is used to select the QMS Audit Schedule data from the QMS Audit Schedule
  3. Account Date : Used to mention the Accounting date
  4. User/contact : Used to select the user name
  5. Period : Used to mention Plan Period
  6. Date Start Schedule : Used to mention the plan start date
  7. Extension Period : Used to give the period for extension
  8. Extension Date : Used to give the Extension Date
  9. Reason : Used to mention the Reason

Critical & onetime setup fields :

  1. Organization : This Field is used to select the organization
  2. Target Document Type : This Field is used to select the type of the document that you are going to process

Non-Critical Fields :

  1. Description : Used to give any note about the document.
Zoom condition’s :

 

Tab

QMS Observation Line

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Critical Fields :

  1. Business Partner : Used to select the business partner name
  2. Auditee : Used to select the Auditor Name 
  3. Observation : This is used to give Observation details for this document.
  4. External Auditor : If we select this checkbox we can give external auditor name.
  5. QMS Result : It is used to give the result status like Ok , Not Ok, OBS
  6. Purchase Order : Used to select PO from Po window
  7. Manufacturing Order : Used to select MO from MO window
  8. Receipt : Used to select Receipt from Receipt window
  9. Inspection : Used to select Inspection from Inspection window

Critical & onetime setup fields :

Non-Critical Fields :

  1. Description : Used to give any note about the document.
  2. Line : Used to mention the sequence number

Zoom condition’s :

Document Actions

Document Actions

Validation

Save :

1.System will check the all mandatory fields

Delete :

1.System will delete the Document and its history details

Document action prepare :

1.System will check the period details and master data's checking

Document action complete :

1.Once document action is complete ,all fields are update in read only

Document action void/reverse correct actual :

1.Void- system will reverse all the transaction data's and change the document status to Void

Document action close :

1.system will check whether all the activity for the document is completed and change the Document status to close.

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