QM101 The Basics and Beyond
QM101 The Basics and Beyond
QM101 The Basics and Beyond
Carl Dunlap
[email protected]
Mike Krug
Why QM?
Why? 9 Improve Quality of your Products 9 Integrate Quality functions within your business 9 Better Quality Metrics 9 If you cant measure it, you cant manage it 9 Support Six Sigma and Black Belt Initiatives 9 Increase visibility across Supply Chain 9 Everybody cant be on the shop floor
Project Drivers
Sample Drivers for Implementing SAP QM Re-calls / Returns of failed product Difficulty in calculating Quality metrics (KPI) Meet regulatory requirements (i.e. FDA) Officers/Directors can be liable Improve traceability of products Integrate Quality into ERP system Save on separate licensing/support costs Eliminate paper forms, spreadsheets, local syst. Standardize and automate QM Process across Plants & Divisions
Easy QM
Some control via posting to QI via an Inspection Lot No results recording, stock managed via inspection lot and usage decision
Standard QM
Post to QI via an Inspection Lot using an Inspection Plan for specifications Requires Characteristic Recording COA Generation
Complex QM
Pos to QI via an Inspection Lot with an Inspection Plan using Sample Maganement, Sample Calculation, SPC, Dynamic Modification, Defects Recording, etc, etc, etc
QM Integration Points
QM Integration Points
QM Integration Points
QM Inspection Types MM
01 Goods receipt insp. for purchase order 0101 - Model inspection at GR for purch. Order 0130 - GR inspection from external processing 07 - Audit inspection for a vendor 08 - Stock transfer inspection 0800 - Insp. lot with insp. stock at QM actvtn 09 - Recurring inspection of batches
QM Integration Points
QM Inspection Types PP
02 - Goods issue inspection 03 - In-process insp. for manufacturing order 04 - Goods receipt inspection from production 05 - Inspection for other goods receipt 13 - In-process insp. for repetitive mfg 89 - Other inspection
QM Integration Points
QM Inspection Types PM
14 - Inspection in Plant Maintenance 16 - Inspection for Storage Condition (Stabi) 1601 - Initial Test (Stability Studies) 1602 - Manual Insp. Lot for Storage Cond (Stab)
QM Integration Points
QM Inspection Types SD
06 Customer Returns 10 - Insp. for delivery to cust. (w/ order) 11 - Insp. for delivery to cust. (w/o order) 12 - Inspection for delivery in general
Run Chart
QM 101 Calibration
Plant Maintenance integration drives calibration functionality Inspections done on Equipment or Functional locations Inspection points used to capture results (inspection lot is created via the PM work order, like an in-process inspection) Multiple ways to capture As Found and As Left results Forward/Reverse traceability report available Tough tolerance limits possible like plus/minus, % of range, and % of standard (custom solution)