Learning path to Quality management

Total Quality Management

ISO 9001 requirements

SAP S/4HANA Quality Mgmt. Processes
Quality planning
Master data management
Production
DMS data
QM
Quality Inspection
Available features
Quality certificates

Incoming Quality certificate (procurement)
Outgoing Quality certificate

Quality notification

Quality notification tools

Audit management
Stability study
QM workflow tools

Batch management
Recurring inspection and expiration date
Active Ingredient management

Quality Management in Logistics

Procurement
Inventory management
Quality Management in Production planning
Quality management in Sales
Integrating QM in EWM

Sample management

Configuration for Sample management
Master data
Business process

Stability Study for a Material
Failure Mode and Effects Analysis and Control Plan
Monitoring and evaluation
QM in logistics

Quality planning
Quality inspection
Result recording
Inspection lot origin
Quality certificates
Quality notifications
Defects recording

Total Quality Management

"Total Quality Management (TQM) is a management technique based on the idea that all “employees continuously improve their ability to provide on-demand products and services that customers will find of particular value." Total Quality: A User’s Guide for Implementation

Here are the main principles of TQM

Customer focus ( Listen to the Voice of the Customer )
Total employee commitment
Process approach
Integrated system
Continual improvement
Fact-based decision-making
Communications

ISO 9001 requirements

Capability and training: necessary qualifications must be attained and records on training status must be maintained (HCM).
Evaluating contractual requirements (DMS).
Development and phase planning (PS, PLM).
Vendors must be evaluated, and procurement specifications must describe requirements adequately.
Controlling production and services (PP: Routing).
Identification and traceability.
Property of the customer (products provided).
Control of monitoring and test equipment.
Internal audit.
Improvements (corrective and preventive measures).

SAP S/4HANA Quality Mgmt. Processes

Planned processes or by event controlled?

What are the requirements for Quality management?

This comes from industry-specific standards ( like VDA, FDA, GMP ( goods manufacturing practices)) .

Quality planning

Master data management (material master, catalogs, selected sets, master inspection characteristics, class characteristics, inspection methods, sampling procedures, sampling schemes, dynamic modification rules, sample-drawing procedures, QM work centers).

QS21: Master inspection characteristics ( physcial property to be checked )

Inspection planning (define inspection criteria as material to be inspected, how the inspection is to take place, characteristics to be inspected, required test equipment, work center and inspection specifications.

inspection plans ( define inspection characteristics, their assignment to inspection operations and the test equipment to be used )
reference operation sets,
material specifications.

Options:

Material Specification with Class Characteristics
Material Specification Without Class Characteristics

Transfer the results of the quality inspection to the batch classification , if the master inspection characteristic is linked to a class characteristic

An inspection plan or material specification is not mandatory for QM inspection lot creation
When an inspection lot is created, the system copies the master inspection characteristics from the inspection plan and material specification into the inspection lot

Control mechanisms for:

Quality inspections (for example, inspection setup, QM-specific data in the material master, QM order, batch management, serial number processing).
QM in procurement (for example, quality info record in procurement, quality assurance agreements in procurement).
QM in production (for example, inspecting by batch, serial number processing, inspection of variant products).
QM in Sales and Distribution (for example quality info record in sales, quality assurance agreements in sales, technical delivery terms).

Master data management

Materials management

Material master (Inspection control)

QM authorization (user groups)
GR processing time to process inspection lot (working days)
Catalog profile ( defects list and locations)
Inspection interval ( repeat inspection for a batch )

Change master record (Material master, inspection plan, Quality info record)
The business partner (inspection plan)

Set a lock with the quality reason

Batch master record (Results recording )

SLED, next inspection date

Production

Routing, reference operation set, rate routing, master recipe (inspection plan, quality notification)
Work centers (inspection plan, quality notification) for quality inspection
Production resources/tools (PRT)

Assign PRTs to operations and inspection characteristics of a task list

DMS data

Quality documents

Quality assurance with vendors (Transaction QV01)
Quality assurance with customers (Transaction QV21)
Technical delivery terms (Transaction QV31)

Inspection method for information or instruction (Transaction QS31)

QM

Catalogs (inspection plan, quality notification)
Inspection type assigned to a material master object
Sampling procedure ( Transaction QDV1 )

Size: Fixed sample, 100% inspection, using the schema, sample percentage,
Valuation mode: accept or reject inspection characteristics

Basic quality and inspection planning data
Master inspection characteristics (inspection plan), Transaction QS21

Quantitative and qualitative
Control settings
Assign the catalog type

Reference operation set (inspection plan)
Inspection plan /routing ( procurement, production, sales ), Transaction QP01

production-based task list type

Tasklist header

Operation

Inspection characteristics
Test equipment

Material specification ( material master, not plant-specific ), Transaction QS61
Quality info record ( procurement, sales ), Link to DMS documents

Procurement

Inspection control

Delivery quantity released for a vendor
The date to for releases
List of quality documents to be used
Whether QM documents are exchanged via EDI
Lead time

Source inspection - No GR ( the inspection will be at the vendor's side )
Status profile

Sales

When and how the inspection lot takes place
What documents are relevant for a delivery

Quality Inspection

Available features

Replace Inspection characteristics or inspection method ( QS27 )
List Inspection characteristics ( QS28)
Delete inspection plan ( CA98)
Inspection lot

Cancel inspection lot ( QA02)
Block temporarily inspection lot (QA02)
List inspection lots with outstanding quantities ( QVM2)

Digital signature ( Cross applications component: used in inspection lot approval, results in recording, usage decision, physical sample drawing )

Define authorization groups
Define individual signatures, then assign it to the authorization groups
Define a signature strategy that defines the sequence and flow of individual signatures and maintains the predecessor-successor relationship.

with a user and password
external security product

Authorization groups for QM master data ( and assign to the strategy)
Signature method
Assign it the materials
Digital signature logs are available (QEDS)

Result recording

Copy inspection results of Inspection lot
Copy Inspection results into Batch classification ( fill characteristics of a batch )

Usage decision

Collective usage decision (AQ16)
Automatic UD (QA10, SKIP status): planned time gap, Automatic UD checkbox,
Reset UD (QA12)
Reverse stock posting ( exit: QEVA0008)

Engineering Workbench (CWBQM): change Inspection plans and Task lists.
Multiple specifications ( use different limits for various vendors and customers in the same inspection plan!)
Dynamic modification rule ( skip a predefined number of inspection lots for results recording and ask a user to enter only a usage decision for the inspection lots )

Configuration

Client level

Replace master insp. characteristics ( inspection plan and material specification )
Replace inspection method ( inspection plan and material specification )
Multiple specifications
ALE settings
BOM usage for QM integration

Plant: Basic data, Insp. lot creation, Results recording, Insp.lot completion, General settings, Visual planning

Quality certificates

Quality certificates help to validate a product conforms to predefined specifications.

In the QM (Quality Management) component for the inspection lot
In the MM (Materials Management) component for a batch
In the SD (Sales and Distribution) component for a delivery

Incoming Quality certificate (procurement)

QM in procurement: Define control key (0005) is to allow or disallow business operations

Release ( quality info record must be created ) and Cert. required

Material master

QM proc. is active
Assign a certification type (0008) to a material master
QM control key

Quality information record

Inspection active

Process

Create a PO, GR (a pop up about a certificate)
QS51: create an incoming quality certificate and set the status
QC55: Incoming certificate worklist

Check the allowed period
Send a reminder

Outgoing Quality certificate

Prerequisites

QC01: Certificate profile (E23C), assign materials for data origin and inspection types
Assign master inspection characteristics to the profile
QC15: Assign the profile to ...

Process

Creating a manual inspection lot
Results recording
Usage decision
QC21: Creation of the outgoing quality certificate

with the reference to a delivery, batch, inspection lot

Quality notification

The aim of the quality notification should be to form a business workflow across several specialist departments.

Quality notifications

F1: Customer-related defect (QM notification in Sales)

Reference to Customer, material sales order, Sales area, delivery note
Process ( QM01 is to create a QM notification, Select a QM notification type )

Object

Set the reference object
Check all related QM notifications for the references

Subject

As additional details, quantity, costs

Items

Causes: Defect ( we can enter a component of an assembly )
Correction tasks: task and status
Corrective actions:

Tasks
Activities
Partner determination

F2: Supplier-related defect (Quality notification in procurement)

Reference: GR document, material, vendor, purchasing org, inspection lot

F3: Material-related defect (QM notification in production)

Reference: Internal partner, material, production or process orders, work center, inspection lot

Q1: Customer complaint
Q2: Complaint against supplier
Q3: Internal problem

Quality notification

Partner
Defect item: activities, tasks, causes
Activities
Tasks

Quality notification tools

QM11 Worklist
QM19 Multilevel notification lists
MCXV Key figures for material
MCVZ Key figures for vendor
ISO1 Solution database
IS02 Solution database by index

Audit management

Stability study

QM workflow tools

Batch management

Recurring inspection and expiration date

The ability to inspect batch-managed goods, whether procured raw materials or produced semifinished or finished goods, before their expiration dates.

Inspection type 09 in the material master
Maintain the inspection interval
Maintain SLED (max, min)

The Next expectation date is calculated for a batch using the Manufacturing date.

QA07 is for Deadline monitoring
MB5L is for Shelf life list

Active Ingredient management

Prerequisites

Activate batch-specific material UoM-s
Create a UoM for proportional units (CUNI)
Create a batch-specific UoM
Maintain proportional factors ( BMA3 )
Define ration conversion
Create a characteristic with the UoM % and set char values
Assign this characteristic to the class ( batch )
Create master inspection characteristics (QS21)
Set the classification to the material master (MM02)
Add a UoM to additional data and maintain the conversion factor, proportional/prod unit
Choose Active ing. UoM as the Order unit in the purchasing view
Set the valuation category X to evaluate the material at the batch level
Inspection type 01
Select Insp with mat.spec.
Create a material specification ( QS61 ): assign the characteristics
(optional) we can create a price for Batch with AI UoM (MWB1)

Process flow

Create a PO with AI UoM as PO unit
Goods receipt for PO
The actual proportion is taken from the usage decision and compared to the planned quantity
Display the AI Valuation price ( MWB3 )
Inspection lot creation ( re-measure ) QE01 and during result recording set new % in AI UoM
Usage decision
Correct purchase order history (MWBQ)

a new material document with the movement type 142

Invoice receipt only for actual ingredient ( proportion )

Quality Management in Logistics

Procurement

Inspection types

01: Incoming inspection for GR for PO

Inspection lot is created after GR
Stock is posted into Quality stock until Usage decision
Result recording & Usage decision
Stock posting
Post Invoice receipt
Release Invoice receipt
Prereq.; Inspection type is in the material master, Quality information record exists (QM control key )
Option: do not post accounting document at GR, then use the movement type 103 ( GR blocked ) and then 105 ( Release GR blocked)

0101: Source inspection for GR for PO

Purchase order
Source inspection ( QI07, QA51 ) => QM inspection lot
Result recording (QE11) & Usage decision (QA11)
Goods receipt of Source inspected materials
Invoice receipt

0102: GR, pilot run ( a new vendor )

Set the status profile ( then it is assigned to the inspection typeS )
PO, GR what triggers..
Inspection lot created for the first status
new PO/, GR what triggers..
Inspection lot creation for the next status dependent on the customizing

0130: GR from external procurement (subcontracting)

Subcontracting purchase order
Goods issue of components
Goods receipt
QM inspection lot
Invoice receipt

Settings

assign a task list type to a material type
define a control key ( technical delivery terms/quality agreements are required to be uploaded in DMS, is Quality info. record is mandatory, should a vendor submit Quality certificate ?, block, block invoice before goods are inspected)

Inventory management

Inspection types

05: Inspection for other goods receipts

GR without PO

08: Stock transfer

Stock transport order
Goods issue
Goods receipt
QM inspection lot

0800: QM activation

Stock placed in QM stock must go under Quality inspection again to avoid inconsistency

Quality Management in Production planning

Inspection types

02 Goods issue inspection
03 In-process inspection for process order
04 Final inspection for R from production
13 In-process inspection for run schedule header

Configuration

Assign the task list type to a material type
Order type-dependent plant parameters (COR4, OPL8 for discrete manufacturing)
Confirmation parameters for a process order
Control key

Are the inspection characteristics required?
Is Automatic GR allowed?

Master data

Material master
BOM
Master recipe, rate routing, routing

Master recipe

Phase

Production version

Quality management in Sales

Inspection types

06 Inspection for customer returns

Create a return order
Create an outbound delivery with the reference
Inspection lot creation
Results recording & usage decision
GR
Issue credit memo

10 Inspection for delivery to customers

Sales order
Outbound delivery
QM inspection lot
Results recording & usage decision
Post GI
Billing

11 Inspection for delivery to customers (without order )

VL01NO

12 General inspection for delivery

Configuration

Assignment of inspection lot origin to the delivery type
Assignment of inspection type to delivery category

Master data

Material master
Customer master
Material pricing condition
QIR (Sales) QV51

Quality inspection: before/after delivery, by customer

Integrating QM in EWM

Sample management

Configuration for Sample management

Plant settings: enter container at GR ( recording is required ), Sample management schema

Master data

QPV2 Sample drawing procedure ( is assigned to an inspection plan, master recipe, routing )

Primary sample: from a material/batch stock
Pooled sample: mixing other physical samples
Reserve sample: store for other inspections

Business process

Purchase order
Goods receipt for PO, enter the container details ( number and UoM)
An inspection lot is created
Confirm Sample withdraw
A physical sample is created: QRP4 release or confirm
QPR5 Inspection lot is created for the physical samples
Result recording for the physical sample

QPR1: Manual creation of a physical sample

Physical sample drawing with reference to production processes

Stability Study for a Material

A stability study assesses and evaluates the physical and chemical conditions of a physical sample in various storage conditions.

For the stability study, inspection types 16 Inspection for Storage Condition, 1601 Initial Test (StabilitynStudies), and 1602 Manual Insp. Lot for Storage Cond is applicable.

QST01 Create stability study: notification type QS, external notification/stability study number.
Action: Create Initial Sample ( Sample condition, storage, quantity, text )
Action: Confirm Initial Sample
Action: Assign Bill of Material ( The stability study usage of a BOM has limited functions because material)
Action: Maintain Bill of Materials
Action: Initial test inspection lot: the system creates an inspection lot and is of inspection type 1601

The master inspection characteristics are taken from the inspection plan that was previously available as a part of the QM master data
QE01: Results Recording and QA11: Usage Decision

Action: Complete Initial Test
Action: Specify Storage Conditions
Action: Store Stability Samples

QPR3: Create the physical sample number

Action: Delete Storage Conditions
Action: Create Testing Schedule

Create inspection lot on the date

Action: Complete Testing Schedule
Action: Print Labels
Action: Manual Inspection Lot for Storage Condition

Failure Mode and Effects Analysis and Control Plan

FMEA ( Transaction QM_FMEA )

The tool with support to answer and evaluate with the following steps:

Review existing business processes: Examine how each component of the process functions and its relation to the other items
List potential failure modes
List the potential effects of failure.
Assign severity rankings to each effect.
Assign occurrence rankings to each cause.
Assign rankings to failure detection.
Calculate the RPN ( Risk Priority Number (RPN) = Severity × Occurrence × Detection; the higher the RPN, the greater the risk ).
Develop an action plan to reduce RPN.
Implement the action plan.
Recalculate the resulting RPN.

Control plan ( Transaction QPCP )

A control plan is a specific and actionable plan to ensure product or process improvements, and it’s the direct outcome of FMEA.

Monitoring and evaluation

QM Cockpit for Evaluations

Transaction QGA4.

Reporting

QA33 Inspection Lot Selection

Early Warning System

Some examples of where EWS can be used:

When quality specifications of material have exceeded a certain level
When the vendor often fails to deliver acceptable quality materials
When a vendor continues delivers late
When production scrap happens more than the certain percent of total production
When the inventory of precious metal exceeds a certain value

Configuration

Organization - settings

Client level: ALE distribution ( inspection characteristics, inspection method, code group )...

Plant level: document changes ( inspection characteristics, inspection method ), presetting lot creation, costs centers ( scrapping and destroying ), storage location for reserve, time for automatic UD.

QM in logistics

Sales and Distribution: To control quality management in Sales and Distribution, the QM component contains an info record for the supply relationship, (that is for the object types customer or for the object types customer, sales organization and material).
Production: The settings described in the subsection 'Quality Planning' / 'Basic Data' also apply to the quality planning activities in production
Procurement:

Control key (V_TQ08-QM_PUR): The control keys in the material master are defined at plant level.

Technical Delivery Terms Required
Quality Assurance Agreement Is Required
Vendor Release Required for Regular Delivery ( Quality info record for QM in procurement )
Certificate Required

With requests for quotations and purchase orders, the vendor is informed of the certificate requirement and certificate type.
At goods receipt, the system checks whether the receipt of a certificate has been already confirmed in the purchase order.

Block Invoice
GR Control for Rejected Source Inspection Lot (a goods receipt is allowed despite the above ? or Create new inspection lot )

Certification type ( V_TQ05-ZGTYP ) is to control the statuses in the certificate profile, to remind and escalate
Delivery block: depending on whether the block applies to all materials or only certain materials for a vendor
QM system: A customer wants a vendor to verify the existence of a QM system that complies with standard ISO 9003. The vendor has a certificate that states that his system complies with ISO 9001, with an audit score > 80.
Status profile is assigne to the inspection type: specify that the delivery of a material from a vendor must pass through a number of statuses

Quality planning

Catalog

Catalog type ( Characteristic attributes Tasks, Usage decisions, Events, Causes, Results of defects, Activities (QM), Defect types, Activities (PM), Object parts, Overview of damage, Failure Mode, Defect Locations )
Defect class.

Inspection Characteristic, Inspection Method

copy models when you create inspection plans or material specifications.

Define Characteristic Weighting ( can it be skipped? )
Define Inspector Qualification
Define Tolerance Keys
Define Estimation Procedure for Fraction of Defects

Sampling: The sampling procedure is stored in the inspection plan for the inspection characteristic, or in the material for the inspection type

Sample determination

Sample type ( by schema, fixed, percentage )
Valuation mode: how a decision is made to accept or reject inspection characteristics (valuation mode). These decisions are used in the sampling procedure

Inspection planning

Assignment of the Task type to a material type
Define task list usage (~ model inspections, goods receipt inspections, inspections for goods returned from a customer, product audits and goods issue inspections ) and assign DCR ( typical dynamic modification criteria for a goods receipt inspection are for example, material and vendor. The quality level is updated for these dynamic modification criteria after each goods receipt inspection)
Task list status
Inspection planner groups ( inside a plant )
Profile with default values
Field selection
Task list type parameters: number range
Multiple specifications: object type ( country, ustomer... class characteristics ) and possible values Canada, Germany...
Operation. Contorl key: Scheduling, Insp.char is requires, Cost

Work center: Qualifications
Inspection characteristics: Origin, Control method

Quality Score Procedure
Define follow up actions -> FM
QM inventory postings with the usage decision ( mapping MvT):

Stock transfers (plant)
Stock transfers (StLoc)
To unrestricted use
To scrap
To sample
To blocked stock
To reserve samples
New material
Return delivery

Transfer Inspection Decision to Batch

LOBM_UDCODE (usage decision)
LOBM_QSCORE (quality score)

Quality inspection

Inspe ction type: Status profile, Order Type for QM Orders As Default Value for Insp. Type, Physical smaple type, UD selected set, notification type, One Q notification per inspection lot, Task list usage, Control key, Operation/Act
Inspection types to Origins
Default values for the inspection types
Inspection for goods movement: deactivate QM for a MvT
Inspection at Shipping: Assign Inspection Lot Origin to Delivery Type, Assign Inspection Type to Delivery Category
Define Quality Score Procedure

Result recording

Recording configuration ( background functions for recording characteristic inspection results )
Origin of result data ( Test equipment, manual, certificate )
Make Settings for Copy of Inspection Results

Sample management

Physical sample type ( FM to print label, status profile )
Physical sample container
Physical sample location

Inspection lot origin

Goods Receipt
Goods Issue
Production
Goods Receipt from Production
Other Goods Receipt
Return from Customers
Vendor Audit
Stock Transfer
Recurring Inspection
Delivery to Customer with Customer Order
Delivery to Customer Without Sales Order
General Delivery
Repetitive Manufacturing
Plant Maintenance
Sample Management
Stability Study
Externally Triggered Inspection
Miscellaneous

Quality certificates

Create a certificate profile; in the profile, assign the sample form QM_CERT_01 (contained in the standard system) to the profile.
Release the certificate profile and assign it to the material.
Define the output dispatch ( LQCA ).
Create a delivery for the material.
Trigger the certificate dispatch for this delivery item.

Quality notifications

Notificatio type: notification category, notification origin, catalog profile, update group.
Define screen layout
Catalogs and Catalog Profiles for Notification Type
Define Partner Determination Procedures
Additional Notification Functions ( action box )
Status management
Digital signature
Costing parameters ( notification type - cost center )

Defects recordering

Confirmation profile
Notification type to inspection type