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



QMS Audit Observation



Critical Fields :

Document No : Individual Identity of the record, It is an unique value

QMS Audit Schedule : This is used to select the QMS Audit Schedule data from the QMS Audit Schedule

Account Date : Used to mention the Accounting date

User/contact : Used to select the user name

Period : Used to mention Plan Period

Date Start Schedule : Used to mention the plan start date

Extension Period : Used to give the period for extension

Extension Date : Used to give the Extension Date

Reason : Used to mention the Reason

Critical & onetime setup fields :

Organization : This Field is used to select the organization

Target Document Type : This Field is used to select the type of the document that you are going to process

Non-Critical Fields :

Description : Used to give any note about the document.

Zoom condition’s :

QMS Observation Line



Critical Fields :

Business Partner : Used to select the business partner name

Auditee : Used to select the Auditor Name

Observation : This is used to give Observation details for this document.

External Auditor : If we select this checkbox we can give external auditor name.

QMS Result : It is used to give the result status like Ok , Not Ok, OBS

Purchase Order : Used to select PO from Po window

Manufacturing Order : Used to select MO from MO window

Receipt : Used to select Receipt from Receipt window

Inspection : Used to select Inspection from Inspection window

Critical & onetime setup fields :

Non-Critical Fields :

Description : Used to give any note about the document.

Line : Used to mention the sequence number

Zoom condition’s :

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.Video