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Quality Master Data

Mariette Miller | Luis Bertorelli


Upon completion of this course participants will be able to:

Explain these Define these Execute these


Processes: Concepts: Actions:

• Catalogs & Sampling • Quality Management • Sampling


Process Master Data • Create & Maintain
• Master Inspection • Selected Sets Inspection Plan
Characteristics • Defect Catalogs • Update Master
Inspection
• Master Selected Sets
Characteristics
• Inspection plan
creation

Course Objectives
QM Material
Master

Sampling
Processes

Quality
Inspection Plan

Inspection Inspection
Catalog
Characteristics Methods

Process Flows
• Batch Class
• The classification data that is kept in the material master, for example:
o Weight
o Technical data
• Batch Characteristic
• Maintained irrespective of class type
• Assigned to classes
• Certificate Profile
• A Profile that contains header data and controls the following:
o Selection of the inspection lots
o Sequence of characteristics
o Characteristic data

Course Key Terms and Concepts


LESSON 1: Sampling Processes
After completing this lesson, participants will be able to:
• Explain the Sampling Process
• Explain the Acceptable Quality Level (AQL)
• Create a Sampling Scheme
• Create a Sampling Procedure

Lesson Objectives
• Sampling Scheme
• A sampling plan that applies to a sample size based on specific inspection lot
quantity
• Defines criteria for determining whether and how a sample is accepted or rejected
• Sampling Procedure
• Defines the rules that specify how the system calculates the sample size
• Contains information about the valuation of an inspection characteristic during
results recording
• Acceptable Quality Level (AQL) Value
• Represents the upper limit of a satisfactory, average quality level
• Relates to acceptance sampling inspection

Lesson Terms and Concepts


• Sample Scheme contains the following:
• Acceptable Quality Level (AQL)
o Represents the limit of a satisfactory average quality level for an acceptance
• Sampling Table
o Arranged according to the lot quantity for each inspection severity
• Inspection Severity
o Identifies type of inspection
Sampling
Table

Inspectio
AQL
n Severity

Sample
Scheme

Sampling Scheme
• Sampling Procedure used at characteristic level
• Rules for determining the sample
• Parameters the system uses to determine a sample size
o Sampling Type
– Defines how a sample is calculated
o Valuation Mode

– Contains the rules for acceptance

Sampling
Type

Valuation
Mode

Sampling Procedure

Sampling Procedure
• Calculation of sample size can be done automatically
• Assign Sampling Procedure
o System calculates the sample sizes based on those specific characteristics

System
Define Aviall Specific Assign Characteristics Automatically
Characteristics to Inspection Plan calculates sample
size

• How do you know if the sample is acceptable?


• Aviall has a standard number of defects permitted per lot

Acceptable Quality Level


Transaction Codes Application
QDP1 Create Sampling Scheme
QDP3 Display Sampling Scheme
QDV1 Create Sampling Procedure
QDV3 Display Sampling Procedure

Key Lesson Transaction Codes


LESSON 2: Create Catalogs and
Inspection Methods
• Catalog
• Provide a means of making sure to use terminology consistently
• QM Work Center
• A physical location at which inspections are conducted

Lesson Terms and Concepts


• Catalogs are used to standardize information on a company-wide basis
• Can directly assign catalogs to:
o Master inspection characteristics
o Assign them using the inspection method
• Stores information at characteristic level in tasks lists
• Easier to record the following:
o Inspection results
o Defects
o Defect locations
• Facilitate usage decisions
• Used to describe the following:
o Defect items
o Tasks
o Activities
o Causes in quality notifications
o Maintenance notifications
o Service notifications

Characteristics of Catalogs
• The system contains the following catalog types

• Create and change code groups in a catalog type


• Group several codes together into code groups
• Create selected sets at plant level that contain codes
from different catalogs

Catalog Types
Transaction Codes Application
QS41 Maintain Catalog
QS42 Display Catalog

Key Lesson Transaction Codes


LESSON 3: Create Master
Inspection Characteristics
After completing this lesson, participants will be able to:
• Explain Master Inspection Characteristics
• Update Master Inspection Characteristics

Lesson Objectives
• Master Inspection Characteristic (MIC)
• An inspection characteristic that is created as a master record
• Intended for frequent use in inspection plans or for evaluation purposes across all
inspection plans
• Selected Sets
• Contains a combination of different codes at plant level

Lesson Terms and Concepts


• Master Inspection Characteristics contain 2 types of data:
• General Data
o Plant, status, assigned catalogs, language key
• Controlled Data
o Sampling procedure, inspection scope, qualitative or quantitative characteristics

• The following are functions for the selected master inspection characteristics

Master Inspection Characteristic (MIC)


• Selected Set contains a combination of different codes at plant level
• Used to combine codes from several code groups
• For Example:
• The codes in the selected set Powdered drink color contain a limited number of colors
that describe the foodstuff
• The selected set Paint color, however, contains color codes that describe the paint color
of a car
• These codes are also contained in the code groups for "Red colors" and "Green colors"

Selected Set
• To Create or change a Master Inspection Characteristic
• Define link between master inspection characteristics and class characteristics
o This enables the automatic transfer of inspection results to the batch classification
• Use control indicators for the inspection characteristic, for example:
o The characteristic type
o Specification limits
Class
o The type of results recording Characteristics
Link
• Assign an inspection method
• Assign Code Groups or Selected Sets
• Inspector Qualification Inspector Control
Qualification Indicators
Master
Inspection
Characteristic

Assign
Assign Code
Inspection
Groups
Methods

Create/Change Master Inspection Characteristic


Transaction Codes Application
QS21 Create Master inspection Characteristic
QS23 Change Characteristic

Key Lesson Transaction Codes


LESSON 4: Create and Maintain
Inspection Plans
After completing this lesson, participants will be able to:
• Create Inspection Plans
• Maintain Inspection Plans

Lesson Objectives
• Inspection Plans
• A task list that may contain the following:
o Material to be inspected
o How the inspection is to take place
o Characteristics to be inspected

Lesson Terms and Concepts


• Why are Inspection Plans created?
• Audit Purposes
• Preliminary series inspection
• Goods receipt inspection
• Goods issue inspection
• Inspection of stock transfers
• Purpose of a inspection Plan:
• Define which characteristics are to be inspected
• Which test equipment will be used in the inspection

Inspection Plan
• To Create an Inspection Plan the following are required:
• Define how this inspection plan is going to be used
• Which materials are to be inspected
• Define the work centers where the inspections will take place
• Which test equipment will be required for the inspection
• Data that must exist in the system include:
o Master characteristics
o Code groups
o Sampling schemes, and procedures
How it is used

Materials

Work Centers included

Test Equipment used

System Data exists

Create Inspection Plan


Transaction Codes Application
QP01 Create Inspection Plan
QP02 Change Inspection Plan

Key Lesson Transaction Codes


COURSE SUMMARY
After completing this course participants are now able to…

Explain these Define these Execute these


Processes: Concepts: Actions:

• Catalogs & Sampling • Quality Management • Sampling


Process Master Data • Create & Maintain
• Master Inspection • Selected Sets Inspection Plan
Characteristics • Defect Catalogs • Update Master
Inspection
• Master Selected Sets
Characteristics
• Inspection plan
creation

Course Objectives Review


Transaction Codes Application
QS21 Create Characteristic
QS23 Change Characteristic
QDP1 Create Sampling Scheme
QDP3 Display Sampling Scheme
QDV1 Create Sampling Procedure
QDV3 Display Sampling Procedure
QP01 Create Inspection Plan
QP02 Change Inspection Plan
QS41 Maintain Catalog
QS42 Display Catalog
QS51 Edit Selected Sets

Key Course Transaction Codes


Contact Information
Mariette.Miler@Getinge.Com
E-mail: Mariette.Miler@Getinge.Com
Location: USA Phone: (973) 362 - 8913
External Consultants: Luis Bertorelli
E-mail: Luis.Bertorelli@Getinge.Com
Location: Guatemala Phone: +502 42120951

www.getinge.com
Getinge is a global provider of innovative solutions for operating rooms, intensive care units, sterilization departments and for life science companies and institutions.
Based on our firsthand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving everyday life.

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