QMS of Plant

Checkpoints
Plant Organization structure is defined. QA Org structure available along with roles and responsibilities
Dedicated QA head for quality function. Adequate manpower in Quality dept
Plant certified for ISO 9001 and all QMS documents maintained
All required gauges, measuring instruments, testing equipment are available. Dedicated lab facility
available
Awareness level about quality in all operators and quality personnel good
In-process Product parameters check-sheet available and checks - carried out at defined frequency
and reports maintained
All the required gauges for in-process parameter checks are available and are duly calibrated
Critical Process parameters are defined, checked at defined frequency, recorded and controlled
Master samples are available on stages and are approved by QA personnel. List of all samples
available & Samples are renewed after defined frequency
NC / rejected parts observed in stages are suitably identified and kept at identified location to avoid
mix-up with ok parts
Type Test report of Product under inspection is available and is valid
Final Inspection checklist is available and is complying with relevant standard
All required Gauges, measuring equipment required for final inspection are available
All gauges, measuring and Test equipment used at Final inspection are calibrated and calibration test
certificates are available and reviewed by person in-charge
Approved Reference / Master / limit / Shade sample / RAL shade cards are available at the point of
inspection
Final inspection carried out as per defined checklist and inspection reports maintained
Accepted lots are suitably identified by tag / sticker / kept in marked finish goods area
Repaired /Segregated materials are re-inspected and re -inspection reports maintained
Rejected material is duly identified by suitable means and kept in separate area to avoid mix-up with
OK material. Record of same is maintained
Adequate illumination observed in Final inspection area
Customer complaints - all major and minor complaints are registered. Entire detail of failed products
are recorded
Immediate Containment action is taken upon receipt of complaints.
All complaints / failure analysis is carried out and causes are identified. Actions taken to resolve the
complaints
Improvements done in Products, Process to resolve the complaints. Related documents revised
accordingly
How to check QMS