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QM_Modified - SA P QM needed much modified
- 3. Receipt of Goods Receipt of Goods In-process and post-process controls In-process and post-process controls Production Production Issue of Goods Issue of Goods Quality management for delivery Quality management for delivery Inspection of raw materials or manufactured Inspection of raw materials or manufactured products upon receipt products upon receipt QM in Logistics Chain 3
- 4. Inquiry Inquiry Vendor Vendor Evaluation Evaluation Purchase Purchase Order Order Goods Receipt Goods Receipt Tech. delivery Tech. delivery requirements requirements Blocked codes Blocked codes Goods Receipt Goods Receipt Returns Returns Tech. delivery Tech. delivery requirements requirements Quality Quality agreements agreements Certificate Type Certificate Type Blocked codes Blocked codes Certificate Certificate Req'd Req'd GR Inspection GR Inspection OK ! OK ! vendor 2 vendor 2 ? ? vendor 1 vendor 1 MM MM MM MM Quality- Insp. Stock QM QM QM QM in Procurement- Overview 4
- 7. Sampling Procedure Inspection Plan Quantitative Characteristics Upper/Lower Control Limits Target Value Qualitative characteristics Attributes Catalogues Material Master QM View Classification View QM-Master Data 7
- 8. Material 1 Vendor Vendor Material 2 Vendor Vendor Service Service Material Material Master Master Vendor Vendor Master Master Release Release Block Block Quality agreements Quality agreements Goods receipt Inspection Goods receipt Inspection QM system vendor QM system vendor Q - Info record Q - Info record A A B B QM- Info Record 8
- 9. Planning Sample drawing procedure Inspection lot processing Automatical creation of physical sample records Determination of physical sample size Confirmation of the physical sample drawing Results recording for physical samples Sample Management 9
- 10. Header Applicability Primary samp. Pooled samp. Reserve samp. Sample-drawing items Confirmation requirement for phys.- sample drawing Calculating physical- sample sizes based on lot quantity or number of lot containers Long text for physical- sample drawing Insp. plan Header 010 Flask 6 Flask 2 Flask 1 100 ml Canister 010 Flask 6 Flask 2 Flask 1 100 ml Canister Sample Drawing Procedure 10
- 11. Inspection lot creation Inspection lot 000000345 Physical-sample drawing 1234678 Sample no. PS2 Sample no. PS3 Sample no. PS4 Sample no. PS5 Reserve samples Primary samples Pooled samples Sample no. RS1 Sample no. PS1 Sample no. PL1 Physical-sample records Sample no. PL2 Creating Physical Sample Record 11
- 12. Processing Distribute physical samples to the labs Lab A Lab B Pooled samples Physical-sample drawing Confirm the drawing of physical samples Record inspection results Insp.lot 345 Lab A Phys.-sample no. PL1 Characteristic 002 Characteristic 001 Phys.-sample no. PL2 Lab B Phys.-sample no. PL1 Phys.-sample no. PL2 Store physical sample(s) Make usage decision Recording Results for Physical Samples 12
- 13. A quality certificate certifies the quality of goods. CERTIFICATE OF ANALYSIS The chemical or physical properties of goods can be recorded as: Inspection results Characteristics for the batch A customer may have specific demands for quality, which may take the form of customer-specific specifications (specification limits), or lead to additional quality inspections. Quality Certificates 13
- 14. This component is used for recording and processing different types of problems (for example, problems resulting from poor-quality goods or services). It can use to analyze the recorded defects and monitor the correction of these problems. In particular, the notifications can help to process internal or external problems such as: Complaints filed by customers Complaints against vendors Company-internal problems Other user-specific problems Stability Studies Quality Notifications 14
- 15. Process improvement Execution Inspection Tasks Problem description Solutions Defects Causes Analysis Problem Management Via Notifications 15
- 16. Status management Nonconformity costs QM costs Q Notification Actions Defects analysis Tasks Evaluations Controlling Workflow Description Archive Link Elements Of Quality Notification System 16
- 17. Purpose In Process Industries Stability Studies are run To monitor the effects of different conditions (temperature, humidity, light...) on a material or batch over a certain period of time Where physical samples of the material or batch are stored under controlled environmental conditions And parts of the physical samples are inspected at planned points in time throughout the study Stability Studies 17
- 18. Create initial sample Create stability study Confirm initial sample Inspection lot for initial test Define storage conditions Process initial test Process stability plan Create stability plan Complete initial test Store stability sample Complete stability planning Define cycle start Schedule Completion of study Stability tests Assign bill of material Stability Studies 18
- 19. Insp.plan 40属 1 2 Insp. plan 21属 1 2 Scheduling Insp. plan 8属 V1 V2 HOW? HOW? Inspection plans with inspection operations and characteristics + WHEN? + WHEN? Inspection operations with inspection dates from strategy WHEN? WHEN? Time-based strategy (e.g., 3, 6, 9, 12, 18, 24, 36 ... Months) Storage cond. 8属 WHAT? WHAT? Storage cond. 21属 Strategy Strategy Inspection Inspection Plan Plan Inspection lot Stability Plan Stability Plan Physical Physical samples samples Stability Studies- Process 19
- 20. CHANGE MASTER RECORD Controls and documents the changes CHANGE NUMBER Ref Number for identifying the changes EFFECTIVITY PARAMETERS Parameters based on which the affectivity of the Change Master is Controlled. Parameters: Class Class Type Date Material Plant Engineering Change Management 20
- 23. Analysis of Quality Parameters 23
- 26. SUMMARY: QM in Logistics Chain QM in Production QM in Sales MIC SAMPLE MANAGEMENT QM INFO RECORD RESULT RECORDING USAGE DECISION PHYSICAL SAMPLES QUALITY CERTIFICATE QUALITY NOTIFICATION Stability Studies QM- Overview 26
- 27. Open House 27