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Documents in TQM
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represent
governing documents
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document quality
management measures
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document results of
quality management measures.
The following documents are used in the
processes of the
QM Process Library.
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Brief summary of the TQM-relevant
documents
Governing documents
Controlled Document
Controlled Documents are fundamental documents of the company (mainly
organizational standards and requirements) whose complete lifecycle is
controlled. This comprises:
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creation
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distribution
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cancellation of validity
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archiving.
Customer Order
Formal and binding assignment of the company by
the customer to deliver products and/or services.
Documentation of QM System
The documentation of the quality management
system consists of
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Quality Manual (comprehensive documentation
of the QM system, quality committment of management and staff,
responsibilities, perspective of the organizational structure - no
more mandatory since release 2015)
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process organization (quality system
procedures)
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work instructions (realization on task
level).
Inspection Plan
Within the Inspection Plan test procedures for
ensuring the quality of supplies and the rendering of goods and services
are planned.
Main input for the inspection plan is the quality
planning.
Job Description
The Job Description describes a defined job.
This comprises
Planning for
Quality
The Planning for Quality contains the quality
attributes required for a product and/or service.
The instruments
of quality planning consist of relevant company specific quality
methodologies. It holds the targets for the inspection planning.
Process
Architecture
Die Prozessarchitektur (Process Architecture)
dokumentiert die Prozesslandschaft des Unternehmens mit allen
Schnittstellen und Prozesskennzahlen zur Sicherstellung des
reibungsfreien Zusammenspiels aller Prozesse.
Process Design
Das Prozessdesign beschreibt den Prozess
gesamthaft. Dies umfasst
Prozessdesigns folgen den Vorgaben der
Prozessarchitektur und des Prozessmanagements.
Process
Documentation
The documentation
of a business process contains at least
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process owner
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verbal short
description of the process
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goals of the
process
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process flow
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process steps
including responsibilities for execution and detailed descriptions
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interfaces to
other processes
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performance
indicators to control and monitor the process performance.
Process Landscape
The Process
Landscape defines the connections of the main business processes on top
level and of the underlying detail processes.
Quality
System Procedure
Quality System
Procedures are basic requirements for defined processes, their control
and documentation.
Quality System Procedure Control of Defective Products and Services
The
Quality System Procedure Control of Defective Products and Services
defines all rules for the handling of goods and services which do not
meet the quality requirements
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products
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identification marking
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documentation
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handling of these products
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secured storage
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definition of activities
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services
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documentation
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handling of these services
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definition of activities.
Quality
System Procedure Control of Test Equipment
The
Quality System Procedure Control of Test Equipment contains all
processes, rules and methods to ensure defined maximum permissible
values for the maximum absolute error of measurement of test equipment
over its life-cycle.
Quality
System Procedure
Document Control
The Quality System
Procedure Document Control describes all rules for handling of
controlled documents
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creation
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checking
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approval
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distribution
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entrainment
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archiving.
Quality
System Procedure
Knowledge Management
The Quality System
Procedure Knowledge Management defines the processes of knowledge
management. This comprises criteria for
of documents.
Quality System
Procedure Process Management
The
Quality System Procedure Process Management defines the requirements to
business processes, their design process and also the requirements to
the process documentation.
Quality
System Procedure
Record Control
The Quality System Procedure Record Control
describes all rules for handling of controlled records
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creation
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checking
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approval
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distribution
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entrainment
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archiving.
Quality
System Procedure
Risk Management
The Quality System Procedure Risk Management
defines
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the process of risk analysis
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the methods for risk evaluation
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the classification of risks
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the processes for risk minimization
respective mitigation.
Quality
System Procedure
Self Assessment
The Quality System Procedure Self Assessment
describes the company specific processes, methods and measurement
criteria for performing a self assessment.
Qualification Plan
The Qualification Plan documents the required
qualifications of the organization on rolling basis.
Operative
implementation is done by means of the training plan and the budgeting
for qualification.
Quality
Management Budget
The Quality Management Budget describes the the
approved financial resources for the quality management as part of the
company budget on a fiscal year basis.
Quality
Management Manual
With the revision 2015 of the ISO 9000 the
quality management manual is no more mandatory but may be used further.
Within the Quality Management Manual the intentions and targets of
the management to ensure and optimize quality based upon the ISO 9001
standard troughout the company are documented. All relevant aspects of
organizational structure, process organization and standards,
regulations and procedures aso. as well are described. The quality
managament manual itself is a mandatory instruction.
Quality Plan
The Quality Plan contains all requirements for
the operationalization of the quality policy.
Quality Policy
The Quality Policy describes the superior ideas
and orientation to quality of products and services of an organization,
as formulated by the top management formally.
The Quality Policy
is inseparable part of the company policy and strategy.
Training Plan
The Training Plan describes all planned
qualification activities for the employees of the company.
Work
Instruction
Work Instructions are detailed
specifications for defined accomplishments, methods to use and
documentation.
Work
Instruction Calibration of Test Equipment
The Work Instruction Calibration of Test
Equipment defines all necessary information for a for a specific test
equipment. This comprises
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infrastructure for calibration
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reference standards
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environmental conditions for the
calibration
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calibrating procedure
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information about documentation and
evaluation of results.
Work
Instruction Customer Satisfaction Survey
The Work Instruction Customer Satisfaction
Survey contains the requirements for the execution of the survey,
especially the questionnaire.
Work
Instruction Evaluation of Maturity
The Work Instruction Evaluation of Maturity
defines all rules for the evaluation of the maturity of the quality
management system, especially the catalogue of criteria.
Measures
for the quality management system
Audit Plan
The Audit Plan carries the relevant planning
data for a particular audit. This comprises:
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time frame
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audit type
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involved persons
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auditors
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aso. .
Audit Planning
The Audit Planning contains the yearly planning
and scheduling of audits for the separate organizational units of the
company.
Based upon particular occurring discrepancies a
replanning during the planning period is possible.
Budget Requirement
for Quality Management
The Budget Requirement for Quality Management
describes the prognosis of expected expenses for quality management on a
fiscal year basis.
Change Request for
Process Architecture
A change request for process architecture is
placed to the process management in case the implementation or
modification of a business service is not possible or causes a reduction
of quality standards based upon the actual process architecture.
Corrective Action
Corrective Actions are defined activities to
eliminate a deficiency
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in quality management system
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in processes
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in products and/or services
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controlled by quality management.
They carry a status of urgency
External
Corrective Action
External Corrective Actions are defined
activities to eliminate a deficiency
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in quality management system
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in processes
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in products and/or services
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of a supplier controlled by quality
management.
They carry an urgency status
External
Preventive Action
External Preventive Actions are defined
activities to avoid the reoccurrence of deficiencies
The carry an urgency status
Preventive Action
Preventive Actions are defined activities to
avoid the (re)occurrence of a deficiency
controlled by the quality management. They
carry a status of urgency
Recommendation
for Process Quality Improvement
Trigger for the optimization of the quality of
company wide processes as input for the process review.
Request for IT system modification
The Request for IT system modification (Request
for Change) is a formal request to perform a change required for all
types of changes not defined as release free standard change.
Supplier
Audit Planning
The Supplier Audit Planning contains the yearly
planning and scheduling of audits for the separate suppliers of the
company.
Based upon particular occurring discrepancies a
replanning during the planning period is possible.
Documentation
of quality
management happenings and
results
Appraisal Interview Protocol
The Appraisal Interview Report contains all
information from the periodic appraisal interview.
This comprises
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targets
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target agreements
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performance appraisals
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miscellaneous agreements
It is created on consensus basis between
employee and line manager signed by both of them.
Audit Protocol
The Audit Protocol documents the immediate
results of the audit.
Business Case
A Business Case investigates a certain scenario
in consideration of the rentability of an investment opportunity.
It is used for the presentation and weighting of predicted economic
and strategic effects of the investment, comparing different possible
realizations. One option always is keeping the actual situation (no
investment).
Complaint Register
Holistic documentation of all customer
complaints including status information.
Controlled Record
Controlled Records are fundamental
documentations of the company (mainly of (intimistic) results of service
provision and control), whose complete life-cycle is controlled.
This comprises
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creation
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distribution
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archiving.
Fault Protocol
Within the Fault Protocol
are documented.
Fulfillment for IT
system modification
The fulfillment for the modification of IT
systems confirms that the change has been implemented in accordance with
the requirements.
Improvement
Register
Holistic catalogue of all improvement
initiatives planned and actually under realization including actual
status information. This includes:
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corrective actions (elimination of
deficiencies)
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preventive actions (avoiding recurrences of
failures)
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optimization actions (detected improvement
potentials especially regarding the maturity)
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development actions (extension of the
quality management system)
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maintenance actions (adaptions without
deficiency in behind).
An entry in the Improvement Register always
comprises a deposit copy according to the quality system procedure for
document and record control.
Quality
Management Forecast
The Quality Management Forecast describes the
estimation of economic results for the quality management based upon
actual costs (and as appropriate earnings) of previous fiscal periods
within a budgeting period looking foreward to the end of the budgeting
period.
Quality Record
Quality Records provide information about the
accomplishment of the company performance and the effectivity of the
quality management system.
It is especially emphasized that the
documents prove the execution of defined controls and that the control
results have been that satisfying, that the checked goods and services
are released for further processing.
Quality
Relevant Occurrence
A Quality Relevant Occurrence is an event
related to
Report
Certification Audit
The Certification Audit Report describes the
results of the certification audit by the external certification
organization
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rating
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findings
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improvement advice.
Report Correction and Prevention
The Correction and Prevention Report contains
all relevant information about planned and ongoing corrective respective
prevention activities.
Report
Customer Satisfaction
The Customer Satisfaction Report carries a
detailed evaluation and analysis of the results of the regular customer
satisfaction survey.
Report External
Audit
The External Audit Report documents the
execution and the results of quality audits performed by external
auditors
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system audits
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process audits
-
product audits
It contains requirements respective proposals
for improvement and correction in case of detected deficiencies
respective improvement potentials.
Report Internal
Audit
The Internal Audit Report documents the
execution and the results of internal quality audits
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system audits
-
process audits
-
product audits
It contains requirements respective proposals
for improvement and correction in case of detected deficiencies
respective improvement potentials.
Report
Management Review
The Management Review Report documents the
results of the management review. This includes
Report Maturity
The Maturity Report documents the results of
the periodic review of maturity for the quality management system.
Report
Process Performance
The Process Performance Report documents the
values for the performance indicators defined for the process on a
periodical basis compared with the defined goals and detected
deficiencies as well.
Report Process
Review
The Process Review Report documents the results
of the Process Reviews. This with (as
appropriate)
Report
Quality Management
The periodic Quality Management Report contains
complete information about the quality situation and the effectivity of
the quality management system. This comprises
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changes of the quality management system
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status of quality goal achievement
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status of employee qualification
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customer satisfaction and reclamations
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internal audits
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status of certification
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audits by customers
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other miscellaneous quality information
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status of activity planning for quality
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control of test equipment.
Besides the company strategy is is a major
input for the definition of the quality policy and the further
development of the quality management system.
Report Self
Assessment
The Self Assessment Report documents the
execution and the results of self assessments. This
for
In case of detected deficiencies respective
improvement potentials it documents requirements and proposals for
improvement.
Report Supplier
Audit
The Supplier Audit Report contains the results
of the supplier audit and evaluates the quality capability of the
supplier.
Additionally it contains requirements for improvement
and correction in case of detected deficiencies.
Risk Log
The Risk Log is a rated catalogue of identified
(conformity) risks and accordingly defined activities for minimization
and mitigation.
Supplier Rating
The Supplier Rating is a method of business
economics for systematic evaluation of supplier's performance according
to defined criteria.
The focus lies on optimization of supplier
relation to optimize the products and/or services to be procured
according to company specifically defined criteria also.
Test
Equipment Database
The Test Equipment Database contains the data
of all test equipment. This comprises
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type
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purpose
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manufacturer
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status (released, repair, calibration,
disabled, removed)
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adjustment data
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calibration data
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reference standards
-
work instruction for the calibration of the
test equipment.
An entry in the test equipment database means
as well the archiving of the deposit copy according to the quality
system procedure for document and record control.
Test Report
The Test Report carries the information of a
performed operational quality test.
Training Record
The Training Record documents all performed
qualification activities for a certain employee.
It is maintained
by human resource department.
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