INGENIEUR
INGENIEUR
Appendix D : Sample QMS Documentation
Manual Corporate
Procedures
Work Instructions / Guidelines Department
Checklists / Forms / Records
Note : Usually these documents are co-related .
Appendix E : Summary of API 20S
AM Metal Printing Equipment Qualification ( Procedures & Record ) Equipment
Hardware Preventive Maintenance Plan which covers equipment servicing and calibration for the facilities involved in MPS but not limited to :
• 3D Printing Machine
• Post-build Processing Facilities such as Stress Relief , Heat Treatment , Hot Isostatic Pressing ( HIP ), Curing , De-powdering , Debinding / Sintering , etc .
Software Procedure to develop and maintain the Digital Product Definition ( DPD ) file , which includes the digital data required for AM components . For instance , CAD files ( e . g ., STL , STEP ), equipment settings , software used and version .
Process
QMS Strategy ( QA & QC ) This section highlights the documentation for the MPS , and emphasise on AM consumable or feedstock ( powder / wire / binder ) AMSL requirement , storage , change plan , reuse , shielding gas , etc .
First Article ( Pilot Run ) This first article shall be manufactured with the same DPD and MPS as the production components and meeting to the necessary testing ( per App . A ).
[ Note : Manufacturing Process Specification ( MPS ) comprises of printing strategy , pre-build check , post-processing activities , Quality Control inspection , and documentation requirements ]
People
Human Competency This column touches on personnel training and competency requirements in the form of Education , Training , Skills , and Experience for :
• AM Operator
• NDE technician
• QC Inspector
[ Note : Usually there will be a need for Vendors to submit the associated documentation to the customer for approval / acknowledgement ]
Note : Company may consolidate both DPD and MPS in the Inspection and Test Plan ( ITP ) to document and outline the quality inspection , test , and survey of the product or process to meet the needed criteria .
62 VOL 98 APRIL - JUNE 2024