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CONSTRUCTIILE SUDATE
WHAT IS QUALITY?
In technical usage, quality can have two meanings:
Quality of design
Quality of conformance
Quality of performance
QUALITY CONCEPTS
QUALITY OF CONFORMANCE
External Failure
Costs
Costs of
Quality
Prevention Costs
sum of all costs to prevent defects
Internal Failure
Costs
Costs for defects incurred within
the system: scrap, rework, repair
Q U A L IT Y S Y S T E M
PERSONNEL
M A T E R IA L
MEANS
D O C U M E N T A T IO N
Quality Concepts
(CONT.)...
competitiveness improvement
product improvement
organisational continuity/growth
personnel motivation
QUALITY ASSURANCE
QUALITY ASSURANCE
METHOD
(to obtain)
- realise as written
- prevent mistakes
- learn from mistakes
OBJECTIVE
(to demonstrate)
Q U AL I T Y
- perform verifications
- prove verifications
Artisan
Quality
Inspection Control
Statistical
Quality
Control
Statistical
Process
Control
Total Quality
Management
Best
Practices
ISO 9000
CAUSE-AND-EFFECT DIAGRAM
Measurement
Measurement
Faulty
testing equipment
Inadequate training
Environment
Environment
Old / worn
Quality
Quality
Problem
Problem
Defective from vendor
Not to specifications
Tooling problems
Lack of concentration
Improper methods
Machines
Machines
Out of adjustment
Poor supervision
Incorrect specifications
Inaccurate
temperature
control
Human
Human
Materialhandling problems
Materials
Materials
Process
Process
Notes:
the term Statistical Quality Control includes nowadays statistical process control and
statistical acceptance sampling
SPC cannot be applied to software products because all copies of software are exactly
identical
TQ: TRANSFORMING AN
ORGANIZATION
From
To
Continuous improvement
C
U
S
T
O
M
E
R
S
a
t
i
s
f
a
c
t
i
o
n
Manage for
R
e
q
u
i
r
e
m
e
n
t
s
Quality
Measure
Analyze,
Improve
Provide
Resources
Develop Quality
Input
Product or Sevice
Product
Output
C
U
S
T
O
M
E
R
Approach
Management Led
Scope
Company Wide
Scale
Philosophy
Standard
Control
Cost of Quality
Theme
On going Improvement
BEST PRACTICES
Best practices refer to the chosen working methods that have been found to be
the most effective and efficient in order to achieve the desired quality.
Expectations >
perceptions
Perceived quality
is poor
Expectations =
perceptions
Customers
perceptions of
product or service
Customers
expectations
for product or
service
Gap
Customers
perceptions of
product or
service
Customers
expectations of
product or
service
Gap
Customers
perceptions of
product or
service
Customers
expectations for
product or
service
Expectations <
perceptions
Perceived quality is
good
Previous
Experience
Image of product
or service
Customers
perceptions
concerning the
product or service
Customers
expectations
concerning a
product or service
Gap 4
Customers own
specification of
quality
Gap 1
organizations
specification of
quality
Managements
concept of the
product or service
Gap 2
Gap 3
Integrity
Independence
Prevention/Improvement
Objective Evidence
Identification/Traceability
Segregation
INTEGRITY
Personal integrity:
professional
physical
Documentation integrity:
technical
physical
obsolete documents
defaced documents
Leadership
Policy and
Strategy
Partnerships
and Resources
Results
People Results
Process
es
Customer
Results
Society
Results
Key
Performanc
e Results
INDEPENDENCE
IDENTIFICATION/TRACEABILITY
Materials
Personnel
Measurements
Design requirements/
verifications
MATERIALS IDENTIFICATION/TRACEABILITY
MEASUREMENTS TRACEABILITY
DESIGN REQUIREMENTS/VERIFICATIONS
TRACEABILITY
DESIGN REQUIREMENTS/VERIFICATIONS
TRACEABILITY (CONTD)
OBJECTIVE EVIDENCE
PREVENTION
Prevention of re-occurrence
old quality
control zone
Sporadic spike
quality
improvement
new quality
control zone
time
SEGREGATION
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
ORGANISATION
ORGANISATION
defined company
organisation structure
written job descriptions
no conflicting
responsibilities
no overlap of duties
responsibilities
commensurate to authority
adequate competence and
abilities
adequate positions
communication methods
information flow (internal external)
open attitude
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
LAWS
REGULATIONS
ADMINISTRATIVE REGULATIONS
STANDARDS, REGULATIONS, GUIDELINES,
SPECIFICATIONS
PROFESIONAL STANDARDS
Seite 56
QUALITY MANUAL
QA PLANS
ISO 8402:
Document setting out the specific quality practices,
resources, and sequence of activities relevant to a
particular product, project or contract
- The quality plan usually references parts of the
suppliers quality manual applicable to the specific case
- The quality plan may be called quality program plan
or quality assurance plan depending on the scope
QA PLANS (CONTD)
P r o je c t " A "
C o n tra c t
Q u a lit y M a n u a l
P r o je c t " A "
Q A P la n
To be meaningful, the QA Plan must build on a preestablished company quality management system. The
reason being that project schedule is usually
incompatible with the time required to start a quality
system from zero.
QA PLANS (CONT.)
WORK INSTRUCTIONS
QUALITY RECORDS
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
INSPECTION
n
n
n
n
n
n
n
n
n
What is an Inspection?
Quality Characteristics
Workmanship standards
Inspection planning
Information for Inspection
Inspection types/techniques
Mandatory Inspection Point
(MIP)
Degree of inspection
Metrology and Calibration
WHAT IS AN INSPECTION?
QUALITY CHARACTERISTICS
ensure
ensure
ensure
ensure
ensure
performance
life/reliability
safety
interchangeability
interfaces
Critical
Major
Minor
Other Not marked
INSPECTION PLANNING
Shop-travelers
Drawings/engineering lists
Workmanship standards
Procurement specifications
Delivery documentation
INSPECTION TYPES/TECHNIQUES
Incoming inspection
In-process inspection
Self-inspection
Final inspection
Source inspection
Non-destructive
inspection
INCOMING INSPECTION
Purchase Orders
- identify deliverable items and quality documents/records
- must be readily available at Incoming Inspection location
Incoming Inspection Instructions
- establish for group of items the verifications to be
performed
Rejected materials
- usually processed for return to supplier
- sometimes processed via in-house (impact on costs)
SELF-INSPECTION
FINAL INSPECTION
SOURCE INSPECTION
NON-DESTRUCTIVE INSPECTION
MIP (CONT.)
MIP (CONT.)
minor
impact on following fabrication operations
impact on item qualification/acceptance
impact on system integration
mission failure
safety
DEGREE OF INSPECTION
Redundant
100% Inspection
Statistical sampling/sampling
1st/Last piece
Audit
Calibration
The set of operations which establish, under specified
conditions, the relationship between values indicated by a
measuring instrument and the corresponding standard or
known values derived from the standard.
ACCURACY OF MEASUREMENT
Target analogy
Accuracy
The degree of agreement of the measurement with the true
value of that parameter. The difference between measured
and true value is defined as error.
Precision
The ability of an instrument to repeat he same reading when
making the same measurement in the same manner and
under identical conditions.
Resolution
The smallest change in input necessary to produce the
smallest detectable change in output of the instrument under
test.
MAINTAINING ACCURACY
From the moment an instrument is put into use it begins to
deteriorate in
accuracy. The procedure for maintaining accuracy includes:
a Number each instrument
a Establish a card record for each instrument
a Establish a checking interval
a Provide for adherence to the checking schedule
a Keep record of the findings of the check
a Analyse the results to take corrective actions (if needed)
a Analyse the trends to modify the intervals (longer/shorter)
CHECKING INTERVAL
Calendar
Amount of use
LEVEL OF STANDARDS
Primary Standards:
These standards (gage blocks, standard cells, standard
electrical bridges) are certified (occasionally) by a
national metrology institute. They are used only to
check secondary standards.
Secondary Standards:
These standards are checked periodically against the
primary standards. They are not used to measure the
product but to check the shop standards
Shop Standards:
These standards are used to check the product itself
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
WHAT IS AN AUDIT ?
AUDITS
System audit
Compliance audit
Process audit
Product audit
SYSTEM AUDIT
COMPLIANCE AUDIT
PROCESS AUDIT
INTERNAL AUDIT
EXTERNAL AUDIT
Preparation
Performance
Conclusions
Report
Follow-up
Audit notification
Opening meeting
Audit performance
Debriefing meeting
AUDIT NOTIFICATION
scope/baseline of audit
schedule
name of lead auditor/auditor/experts
draft agenda
OPENING MEETING
Introduction of attendants:
assigned rooms
documentation access
PERFORMANCE OF AUDIT
REMINDER:
In the conduct of the audit keep in mind that the
Customer/Supplier relationship of the past that
operated in an adversarial environment is becoming
ancient history
DEBRIEFING MEETING
Debriefing meeting:
meeting with the management of audited organisation
each auditor presents his Observations Sheets (OS)
provide clarifications
collect signatures (if not yet done), as recognition that
each reported observation is as verbally indicated
during the audit
audit team leader presents opinion on the audit results
request formal response to each observation
AUDIT REPORT
Audit Report:
AUDIT FOLLOW-UP
Evaluate response:
AUDIT TERMINOLOGY
Observation
An observation is made every time a total absence of
arrangements to meet an important requirement or
arrangements which are clearly inadequate is found.
Observations are also made when lack of
implementation of Quality Manual or procedures is
revealed.
The term Non-Compliance is also often used as
synonym.
Recommendation
A Recommendation describes an acceptable solution to
an observation. A recommendation should be written
when it considered helpful to speed-up the achievement
of agreement on a corrective action.
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
NON-CONFORMANCE PROCEDURE
NON-CONFORMANCES: DISPOSITION
MANUFACTURING/TESTING
OR
RECEIVING INSPECTION
QUALITY CONTROL
or other
authorised unit
PREPARES DISCREPANCY
NOTICE (DN)
SEGREGATION
PRELIMINARY
REVIEW (PR)
QA CONDUCTS PR
DISPOSITION FOR SRP
OR MINOR REWORK
PROMOTION TO MRB
MATERIAL REVIEW
BOARD (MRB)
QUALITY ASSURANCE
CUSTOMER PARTICIPATION
FOR MAJOR NCR
MRB DETERMINES
DISPOSITION
NCR PREPARATION
NOTIFIES OF FORTHCOMING
MRB
ASSESSES CUMULATIVE
EFFECT OF PREVIOUS NCRs
NO
YES
WAIVER
QUALITY ASSURANCE
VERIFIES CORRECT
IMPLEMENTATION OF
DISPOSITION (after
implementation)
CUSTOMER
CONDUCTS CCB
DISPOSITIONS AND
APPROVES WAIVER
CONTRACTUAL
AUTHORIZATION TO
PROCEED WITH
WAIVER
CONFIGURATION
MANAGEMENT
WAIVER NUMBERING
SCHEDULES CHANGE
BOARD (if needed)
QUALITY ASSURANCE
Purpose of the MRB is to provide an organised review of nonconforming product. The MRB is chaired by QA with members
from Engineering and other specialists teams (e.g. Materials,
S/W)
Members of the MRB have collective responsibility and
specific responsibility. Specific responsibility relate to the field
of specialisation.
Specific responsibility of the QA function in the MRB is to:
- investigate root causes to identify corrective/preventive
actions
- ensure that remedial actions are properly
implemented
- ensure that the process is correctly followed and
records kept
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
TRAINING
TRAINING (CONT.)
Welding
Adhesive Bonding
Electronics Assembly
Conformal Coating
NDI
Metrology
Organisation
Inspections
Audits
Nonconformance Control
Training
Qualifications/Certifications
QUALIFICATION/CERTIFICATIONS
Qualification
process qualification
product qualification
Certification
CERTIFICATE OF CONFORMITY
PERSONNEL CERTIFICATION
the contractor
a space agency or a delegated organisation
a nationally recognised organisation
certification expiration
interruption of work
unsatisfactory performance
evolution of techniques
STAMP WARRANTY
<<>>
Procurement
Manufacturing
Testing
Acceptance/ delivery
Requirements,
Concept of System
Demonstrate and
Validate the System
Integrate System,
perform System
Verification
System Specification
Sy Verification Plan
CI Specification,
CI Verification Plan
De
c
om
po
si
Se tion
qu an
en d
c e De
f
Fabricate, Assemble
and Code
gr
te
In
ic
rif
Ve e
d c
an en
n
u
io q
at Se
n
io
at
producibility
repeatibility
inspectability
testability
Functional Requirements
Tasks, actions or activities that must be accomplished
by a system, without specifying how it has to be done
Performance Requirements
The extent to which a function must be executed,
generally covered in terms of quantity, quality,
coverage, timeliness or readiness
Design Constraints
Boundary conditions within which the designer must
remain while allocating performance requirements
and/or synthesizing system elements (safety,
environmental, interface, technology etc.)
complete
consistent
unambiguous
verifiable
traceable
The
TheQA
QAfunction
functionmust
mustensure
ensurethat
thatdesign
designrequirements
requirementsare
areproperly
properly
documented,
documented,and
andverifications
verificationsconsistently
consistentlyplanned
plannedand
andthoroughly
thoroughly
executed.
executed.Ensure
Ensurethat
thatQUALITY
QUALITYis
isdesigned
designedinto
intothe
theproduct.
product.
Procurement
Manufacturing
Testing
Acceptance/ delivery
PROCUREMENT CONTROL
Surveillance of suppliers
pre-award audit
Maintain
Maintainaalist
listof
ofsubcontractors
subcontractorsand
andsuppliers
suppliers including
includingrecords
records
of
ofsupplies
suppliesand
andperformance
performancedata
data(e.g.,
(e.g.,%
%of
ofdefective
defectiveitems,
items,NCRs)
NCRs)
Purchase
PurchaseOrders
Orders(PO)
(PO)and
andContracts
Contractsshall
shallbe
bereviewed
reviewedand
andformally
formally
approved
approvedby
bythe
theQA
QAfunction
functionprior
priorto
torelease.
release.
SURVEILLANCE OF SUPPLIERS
The
TheQA
QAplan
planshould
shouldalways
alwaysprovide
provideinformation
informationand
andjustification
justification
on
onthe
theplanned
planned surveillance
surveillanceactivities
activitiesof
ofsubcontractors
subcontractorsand
andsuppliers.
suppliers.
Procurement
Manufacturing
Testing
Acceptance/ delivery
MANUFACTURING
Control of manufacturing
processes
Control of manufacturing
documents
correct /traceable
conforming
within their useful life (if life limited)
Ensure
Ensurethat
thatshop-travelers
shop-travelersalways
alwaysinclude
includematerials
materialsand/or
and/orparts
parts
identity
identityverifications
verificationsas
asfirst
firstoperation.
operation.
Ensure
Ensurelimited-life
limited-lifematerials
materialstracking
trackingand
andlabeling
labelingwith
withexpiration
expirationdates.
dates.
documented
tested and approved prior to use
configuration controlled
secured to prevent tampering and misuse
The
TheQA
QAfunction
functionmust
musthave
haveaaprimary
primaryand
anddocumented
documentedrole
rolein
inthe
the
validation
validationand
andcontrol
controlof
ofproduction
productiontools,
tools,including
includingany
anysoftware.
software.
Cleanliness levels
The required cleanliness levels of contaminationsensitive items will be indicated on specifications,
drawings and procedures
Cleanliness of facilities
Clean facilitiesconditions and operations need to be
controlled to ensure that their specified level of
cleanliness is maintained.
The
TheQA
QAfunction
functionhas
hasaaprimary
primaryrole
rolein
inenforcing
enforcingcompliance
complianceto
tothe
the
Contamination
ContaminationControl
ControlPlan
Planand
andverification
verificationof
of clean-facilities.
clean-facilities.
MANUFACTURING PROCESSES
Process
A sequence of pre-defined steps intended to achieve a
goal or objective
Manufacturing process:
Special Process
Critical Process
Standard Process
SPECIAL PROCESS
CRITICAL PROCESS
DEFINITION
.
A process that in the case of failure can adversely affect the performance
- The quality of which cannot be assessed solely by examining the end product
- A process that has caused problems previously
- A process with which the contractor in charge of it has had no previous experience
STANDARD PROCESS
Manufacturing documents
identified/traceable to contract no./purchase order
include rev.status/date, release date
include item identification and configuration data
kept with product during manufacturing/inspection
operations
include provisions for traceability of operators and
inspectors.
Procurement
Manufacturing
Testing
Acceptance/ delivery
Test reviews
Test surveillance
Test documentation:
test procedures
test reports
Procurement
Manufacturing
Testing
Acceptance/delivery
ACCEPTANCE/DELIVERY
Acceptance review
RB responsibilities:
ACCEPTANCE/DELIVERY
QA is a member of the RB
QA
QAhas
hasaaleading
leadingrole
rolein
inacceptance
acceptanceand
anddelivery
deliveryactivities
activitiesand
and
must
mustbe
bedirectly
directlyinvolved
involvedin
intheir
theirperformance
performance
QUALITY ASSURANCE
QA Standards
GENERAL STANDARDIZATION
International level
Management
responsibility
Quality system
Contract review
Design Control
Document and data
control
Purchasing
Control of customer
supplied product
Product identification
and traceability
Process control
Inspection and testing
Control of inspection,
measuring and test
equipment
Control of quality
records
Internal quality
audits
Training
Servicing
Statistical
techniques
FOCUSES
Concept of integration
Concept of PDCA
Performance
Plan
Act
Do
Check
Continuous
improvement
Time
Empowerment/
Shared Leadership
Customer
Satisfaction
Business
Results
Team
Management
Process
Improvement/
Problem
Solving
Measurement
Measurement
Measurement
Measurement
ENVIRONMENTAL MANAGEMENT
GENERIC STANDARDS:
ISO 9001 and ISO 14001 are generic standards.
Generic means that the same standards can be applied:
to any organization, large or small, whatever its
product or service,
in any sector of activity,
and
whether it is a business enterprise, a public
administration, or a government department.
no matter what the organization's scope of activity
if it wants to establish a quality management
system, ISO 9001 gives the essential features
or if it wants to establish an environmental
management system, ISO 14001 gives the essential
features.
MANAGEMENT SYSTEMS:
ACCREDITATION
QUALITY ASSURANCE
Part III : Special techniques
STATISTICAL TECHNIQUES
Statistical acceptance
sampling
Process performance
Is the day-to-day behavior of a process including all random
and assignable-cause effects
Process capability
Is an estimate of the best performance of which a process is
thought to be capable, with all effects of controllable,
assignable-cause variation removed
x
x
x
x
mean
x
-3
x
x
x
x
x
Production Sequence
STATISTICAL TECHNIQUES
Statistical acceptance
sampling
d
c , lot accepted; otherwise rejected and
controlled 100%
N = lot size
n = sample size
c = acceptance number
d = number of defective items in sample
p = % of defective items in lot
number of defective
lower limit, accept
number of defective
upper limit, reject
number of defective between limits, take new sample
new accept/reject limits for the 2 samples
^
Multiple sampling
- steps 1, 2, 3, as above
continue sampling until accept or reject is achieved.
COST OF QUALITY
- Quality planning
Steps to ensure producible/robust design
Metrology and calibration
System audits
Process capability evaluations
Process qualifications
Training
Quality improvement projects
- Design reviews
- Incoming and source inspections
- In-process and final inspection/test
- Product and process audits
Productivity loss
Artisan
Team
Defined Organization
methods
Best
Quality practices
system
Standards
Continuous
process
improvement
Examine
organisation's
needs
Validated improvement
Institutionalised
results
Sustain
improvements
Monitor
performance
Confirm the
improvement
Re-Assessment
Request
Improvement
initiation
Initiate
process
improvement
improvement
gain
Implemented
improvements
Analysed
assessment
results
Perform
process
assessment
Preliminary
improvement
programme plan
Analyse
results
and
derive
action
plan
Assessment
results
Implement
improvement
Approved
action plan
THANK YOU!!!