CAPA for Organogram

Quality Assurance
1

in recent audit one observation comes for Organogram .
QA AND QC NEED TO BE SEPRATED.

Kindly guide how to fill the CAPA for this. auditor ask for change control and CAPA.

2

Corrective action - prepare separate organogram for qa and qc.Revise the sop.
Preventive action- training should be imparted to concerned person.

1 Like
4

thanks sahab, i had one more quaery. I need risk assessment study based sampling location for viable count in our manufacturing room

5

You should choose worst location where are more possibilities of contamination.for eg. Near entry exit door,near return riser,location where more man material movement occurs.

2 Likes
6
  1. prepare seperate organogram for both department this is the corrective action.
  2. both the department work in order to execute the organogram with proper reporting this is the preventive action
  3. according to above CAPA revise the SOP which will be represented by Change Control by attaching organogram & training attendance sheet as attachment or annexure with duly sign. & closing comment by QA head.
1 Like