- Sonali Phadke

QUALITY PLANNING AND ANALYSISBasic concepts of Quality assurance

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

Questions:

› 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

E.g. of departmental assurance activities.1. Marketing : product evaluation, controlled use of product, special surveys, product monitoring2. Product development :design review, reliability review, safety analysis, maintainability analysis3. Production : design review, process capability analysis, preproduction trials, review of manufacturing planning.

› 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

• 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.

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)

› 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

• 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.

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

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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› 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

• 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.

• 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

› 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

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.

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.

› 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

› 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.

A. Organizational design1. Management responsibilities2. Job descriptionsB. Customer management practices1. Corrective action2. Servicing3. Complaint and inquiry handling4. Recall & field correctionC. Organizational & individual development practices1. Training2. Personnel hygiene

Essential Ingredients Of Quality Audit Program

D. Product development practices1. Device design control2. Concept generation3. Device development4. Transfer of operationsE. Product & process control practices5. Process control6. Special processes7. Process capability8. Facilities and equipment9. Control of contamination10. Recovered materialsF. Procurement practices1. Purchasing2. Contract review

G. Warehousing & distribution practices1. Handling, storage, distribution & installationH. Quality assurance practices1. Product identification &traceability2. Acceptance activities3. Nonconforming goods4. labellingI. Information analysis practices 1. Inspection, measuring and test equipments2. Statistical controlJ. Document management practices1. Document control & quality records2. product registration & approval dossiers

› 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

› 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.

Following the surveys, the team reports its findings which consists of1. 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.

› A scoring system includes importance weights for activities judges the supplier’s quality system meets the requirements or not.

10: specific activity is satisfactory8: meets with min. requirement but improvement could be made3:the activity is unsatisfactory

Activity rating

Quality managementQuality planningDrawing controlStorage and shippingenvironment

81081010

› 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

› 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”

› 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

› 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

› 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.

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

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