quality planning and analysis ( J. Juran)

1. - Sonali Phadke
QUALITY PLANNING AND ANALYSIS
Basic concepts of Quality
assurance

2. › Discuss steps in structuring an audit program.
› What are essential components of an audit report.
› Audit preparation
Questions:

3. › Quality assurance is activity of providing evidence to establish
confidence that quality requirement will be met.
› ISO : All the planned and systematic activities implemented
within quality system and demonstrated as needed, to provide
adequate confidence that entity will fulfill requirements of
quality.
› The assurance comes from evidence (a set of facts).
› For simple products, it is usually some form of
inspection/testing of product.
› For complex products, evidence is inspection and test data
and also reviews of plans and audits of execution of plants.
Quality assurance :Definition

4. E.g. of departmental assurance activities.
1. Marketing : product evaluation, controlled use of product,
special surveys, product monitoring
2. Product development :design review, reliability review, safety
analysis, maintainability analysis
3. Production : design review, process capability analysis,
preproduction trials, review of manufacturing
planning.

5. › It is independent review conducted to compare some aspect
of quality performance with a standard for that performance.
› ISO 10011-2-1994 : A systematic and independent
examination to determine whether the quality activities and
related results are comply with planned arrangements and
whether these arrangements are implemented effectively and
are suitable for achieving objectives.
› The specific purpose of quality audit is to provide independent
assurance that
• Plans for attaining quality
• Conformance to specifications
• For safe for user and fit for use
Concept of Quality Audit

6. • Deficiencies are found and corrective action is taken.
• Procedures are adequate and being followed.
• Opportunities for improvement are identified.
Companies use quality audits to evaluate their own quality
performance and performance of their suppliers, licensees,
agents ;regulatory agencies do not evaluate the performance of
organization they regulate.

7. Audits
External audit
Second party
(conducted within
supplier’s organization by
organization that making
a purchase from supplier)
Third party
(by auditing organization
independent of
purchaser of supplier)
Internal audit
First party
(within organization by
auditor employed by
organization)

8. › For simple product the range of audit is also simple and is
dominated by product audits; but in complex products, audit
is complex.
› In large companies, more than one approaches to divide up
subject matter,
• Organizational units: comprise several layers of organization;
each specific assigned mission ; corporate office ; operating
office, operating divisions, plants etc. ; use multiple teams of
quality auditors.
• Product lines: audit evaluates the quality aspects of specific
product lines (printed circuit boards, hydraulic pumps).
Subject matter of audit

9. • Quality systems : Audits the are directed at the quality
aspects of various segments of the overall systematic
approach to quality such as design, manufacturing, supplier
quality and more processes.
• Specific activities : may be designed to single out specific
procedures that have special significance to quality mission,
disposition of nonconforming products, documentation,
instrument calibration, software.

10. Audits of individual tasks or systems of tasks are usually
structured. They are designed to carry out agreed upon purpose
and are conducted under agreed rules of conduct.
Three essential participating groups:
• The heads of the activities which are to be the subject of
audit.
• The heads of auditing department.
• The upper management which presides over both.
Audits are often done by full time auditors who are skilled in
both technical and human relations aspects.
Structuring The Audit Program

11. Audit
department
Line
department
Upper
management
Discussion of purpose to be achieved
by audit & general approach
Drafts of policies, procedures, other
rules to be followed
Final approval
Scheduling of audit
Conduct of audit
Verification of factual findings
Discussion on reports
Decision to be taken
Subsequent follow up
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12. › The major steps in performing on audit are planning,
performing, reporting, follow ups on corrective action and
closure.
• Legitimacy: The basic right to conduct audits is derived from
the “ charter” that has been approved by upper management.
Also other questions like scope, objective, subject matter of
audit. The auditor acts within the provisions of charter plus
supplemental agreements.
• Scheduled versus unannounced : Most auditing is done on a
scheduled basis. “No surprise, No secrets”. This practice
enables all concerned to organize workloads, assign personnel
etc. in orderly manner.
Planning Audits Of Activities

13. • Customer : The customer who is affected by an audit. Key
customer is a person responsible for activity being audited.
Other may include upper management, functions affected by
activity.
• Audit Team : Audits are conducted by individuals or by a team.
Team contains lead auditor ( who plans, conducts the meeting,
reviews the findings and comments of auditor, report
prepares, evaluate corrective action, presents audit report.
• Auditors must be open minded, possess sound judgement,
have trust and respect line management.
• The use of reference standards and checklist is one another
way where auditor is expected to compare activities as they
are with some objective standard of what they should expect.

14. • The reference standards are normally available include written
policies of company as they apply to quality.
• E.g. Standard objectives in budget, programs, contracts.
Customer and company quality specifications
Company, industry and other pertinent quality standards
on products, processes and computer softwares.
General literature on auditing

15. › Auditors are human beings and in practice, their relationships
with those work is being audited becomes quite strained.
› Deficiencies turned up in the audit may be resented because
of implied criticism.
› These and other human relations problems are sufficiently
important to warrant extensive discussion plus indoctrination
of both auditing personnel and operation personnel with
respect to following issue :
 The reason behind audit : The reasons may have been well
discussed during the basic formulation of audit program. The
discussion was held among managers. Need to explain to
supervisor and non supervisor the “why” of the audit.
Human Relations In Auditing

16. Avoiding the atmosphere of blame: A sure way to cause a
deterioration in human relations is to look for someone to
blame rather than now to achieve improvement. Audit and
recommendation should be problem oriented rather than
person oriented.
Balance in reporting: An audit that reports only deficiencies
may be factual as far as it goes; yet it will be resented because
nothing is said about for greater number of elements of
performance that are done well.
Depersonalizing the report: Auditors derive much influence
from the fact that their reports are reviewed by upper
management. Auditing department should be careful to
avoiding misusing this influence. The ideal is to depersonalize
the reports and recommendation.

17. Post-audit meeting: an important part of implementation
phase is post-audit meeting i.e. held with manager of audited
activity.
At this meeting, the audit observation are presented so that the
manager can plan for corrective action. The manager can point
out to auditor any mistake with respect to facts that have been
collected.

18. › It should be documented in report & a draft should be
reviewed with management of activity that was audited. All
the members of audit team & auditee should report the
report.
› The report should include following points:
• Executive summery
• Purpose & scope of audit
• Details of audit plan (personnel, date, activity audited)
• Standards, checklist, other reference documents used during
audit
• Recommendation for improvement opportunities
• Distribution list for audit report.
Audit Reporting

19. › Summarizing the audit data : There are two types of
discrepancies which have report like
A report of each discrepancy of subject matter to secure
corrective action
A report of overall status of subject matter under review
To meet these, evaluate all quality performance provide
evaluations of the status of major subdivisions of the overall
performance; provide some estimate of frequency of
inadequacies in relation to number of opportunities for
inadequacies.
Copies of audit report are sent to upper management for
notification, review and possible follow up. The report is sent to
only to the manager whose activity is audited and follow up
audit is scheduled.

20. A. Organizational design
1. Management responsibilities
2. Job descriptions
B. Customer management practices
1. Corrective action
2. Servicing
3. Complaint and inquiry handling
4. Recall & field correction
C. Organizational & individual development practices
1. Training
2. Personnel hygiene
Essential Ingredients Of Quality Audit Program

21. D. Product development practices
1. Device design control
2. Concept generation
3. Device development
4. Transfer of operations
E. Product & process control practices
1. Process control
2. Special processes
3. Process capability
4. Facilities and equipment
5. Control of contamination
6. Recovered materials
F. Procurement practices
1. Purchasing
2. Contract review

22. G. Warehousing & distribution practices
1. Handling, storage, distribution & installation
H. Quality assurance practices
1. Product identification &traceability
2. Acceptance activities
3. Nonconforming goods
4. labelling
I. Information analysis practices
1. Inspection, measuring and test equipments
2. Statistical control
J. Document management practices
1. Document control & quality records
2. product registration & approval dossiers

23. › A supplier quality survey is an evaluation of the ability of a
supplier’s quality system to meet requirements on production
lots i.e. to prevent, identify, remove any product that doesn’t
meet requirements.
› This helps in supplier selection process or, if supplier has
already been chosen, it may help supplier meeting
requirements. The survey can be simple questionnaire mailed
to supplier to a visit to a supplier’s facility.
› The most formal quality survey consists of a visit to supplier’s
facility by a team of observer from departments like quality,
engineering, manufacturing & purchasing.
Quality Survey

24. › Depending on the product involved, the activities included in
quality portion of survey can be chosen from following list:
• Management : philosophy, quality policies, physical
organization, structure
• Design : organization, system in use, orientation to modern
techniques, reliability
• Manufacture : physical facilities, maintenance, special
processes, capability of process.
• Quality : organizational structure, quality planning
• Inspection & tests: labs, special tests & instruments
• Data system: facilities, procedures, effective use reports.

25. Following the surveys, the team reports its findings which
consists of
1. Objective findings as to the supplier’s facilities (or lack of
facilities)
2. Subjective judgements on the effectiveness of supplier’s
operation.
3. Further judgement on effectiveness of the supplier’s
operation.
4. A highly subjective prediction whether supplier delivers a
good product if awarded a contract.

26. › A scoring system includes importance weights for activities
judges the supplier’s quality system meets the requirements
or not.
10: specific activity is satisfactory
8: meets with min. requirement but improvement could be
made
3:the activity is unsatisfactory
Activity rating
Quality management
Quality planning
Drawing control
Storage and shipping
environment
8
10
8
10
10

27. › It determines an independent evaluation of a product’s quality
to determine its fitness for use and conformance to
specification. Product auditing takes place after inspections
have been completed.
› The purpose includes :
• Estimate the quality level delivered to the customers.
• Evaluating the effectiveness of inspection decisions in
determining conformance to specifications.
• Providing information useful in improving the outgoing
product quality level.
The product audit should compare actual service performance
with user’s service needs.
Product Audit

28. › For simple products, a representative sample of finished
goods may be brought on open markets. These samples are
then checked for fitness for use and conformance to
specifications.
› For complex consumer products e.g. household appliances.,
its feasible to secure product audit data at multiple stages of
product progression.
› The most extensive product audit takes place immediately
following factory inspection & testing.
› Additional audit data are then secured from selected
distributors & dealers under special joint “ open & test audit”

29. › Sample sizes for product audit can be determined by using
conventional statistical methods.
› These methods determine the sample size required for stated
degrees of risk.
› In some cases of highly homogeneous production, a sample of one
unit taken from batch production can be adequate for product
audit.
› Sampling can be done by
• By taking sampling means
• Using operating characteristics curves
• ANOVA
• Regression analysis
• By estimating hypothesis
Sampling For Product Audit

30. › The results of the product audit appear in the form of the
presence or absence of defects, failure etc. A continuing score
or “rating” of quality is then prepared based on audit results.
› Product audit programs often use a seriousness classification
of defects. Defects are classified in the term of like critical,
Minor A, Minor B each with some weight in the form of
demerits.
› In the product audit, the usual unit of measure is demerits per
unit of products.
› The actual number of demerits per unit for the current month
is often compared against historical data to observe trends.
Reporting The Results Of The Product Audit

31. › A major value of measure such as demerits per unit is that it
compares discrepancies found with the opportunity for
discrepancies.
› It is often useful to summarize the product results in other
language. Product result can also be summarized to show the
effectiveness of the previous inspection activities.
› Typically, a simple ratio is used, like percentage of total defects
detected by inspection.

32. 1. Quality planning and analysis, 5th edition, J. M. Juran and F.
M. Gryan; Tata McGraw Hill, India. Page no.
References:

33. Thank
you
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