Quality AssuranceQuality AssuranceBy. Henmaidi, PhD.

Industrial Engineering, Andalas University, IndonesiaBased on Quality Planning and Analysis Ch. 24 by Juran

Outline1. Definitions2. Concept of QA3. Quality Audit4. Subject Matter of Audit5. Structuring the AUDIT Program6. Planning and Performing Audits on activity7. Human Relations in Auditing 8. Audit Reporting9. Essential ingredient of a Quality Audit Program10.Quality Surveys11.Product Audit12.Sampling for Product Audit13.Reporting the results of Product Audit

1. Definitions

• QA is the activity of providing evidence needed to establish confidence that the quality related activity are being performed effectively.

• ISO 8402-1986 defined QA as related to product or service. All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirement for quality

2. Concept of QA• Many QA activities provide protection against

quality problems through early warnings of trouble ahead

• The assurance comes from evidence – a set of facts: like inspection or testing of a products

• For cpmplex products, the evidence also reviews of plans and audit of the excecution plans

• Quality assurance is similar to financial Audit: provides assurance of financial integrity by establishing independent audit

3. Quality Audit• Quality Audit is an independent review to compare some

aspects oy quality performance with a standard for that performance.

• Term of “Independent” is critical that the reviewer (auditor) is neither a person responsible for the performance under review nor the immediate supervisor of that person

• ISO 8402-1986: quality audits is a systematic, independent examination and evaluation to determine whether quality acivities and results comply with planned arrangement and whether the arrangement are implemented effectively and suitable to achieve objectives.

• Quality audit used to evaluate own quality performance, supplier, licensees, agents and other

• The purpose: to provide independent assurance that:– Plant for attaining quality be attained– Products are fit for used and safe for the user– Standard and requlation are being followed– There is conformance to specification– Procedures are adequate and are being followed– The data system provides accurate and adequate information on

quality to all concerned– Deficiencies are identified and corrective action is taken– Opportunities for improvement are identified and the appropriate

personnel alerted

4. Subject Matter of Audit• In large companies, program of audits use one or more

of the following aproaches:– Organisational units: it is common to use multiple teams of

quality auditor– Products lines: Audit evaluate the quality aspects of specific

product lines, from design through field performance– Quality systems: the audits are directed at the quality aspects of

various segment of the all systematic approach to quality, such as design, manufacturing, supplier etc. A system quality audit reviews any such system over a whole range of products.

– Specific activities: audit is designed to a single out specific procedures which have special significant to the quality mission.

• Identifying Opportunities– Alert auditor often able to discover to discover opportunity for

improvement as by product of her search for discrepancy

5. Structuring the AUDIT Program• Audits usually structured: they are designed to

carry out agreed purposes and conducted under agreed rules of conduct

• Reaching this agreement requires collaboration among 3 essential participating group:– Head of activities which are to be subject of audit– Head of auditing department– Upper management

• Usual failure modes:– Abrasive relationship bentween auditor and line

manager– A failure of a line manager to heed the audit reports.

6. Planning and Performing Audits on activity• ANSI/ASQC (1986) identifies the main steps in

performing activity audits as: – initiation, planning, implementation, reporting and completing.

• Important policy issues:1. Legitimacy: the basic right: from the approved ‘charter’. Other

question: what shall the subject matter of the audit? Should the auditor be accompanied? Whom may the auditor interview?

2. Scheduled vs unannounced. Most audit: schedulled basis. “No surprise, no secret”. This will minimise irritations. There are some situations like banks audit, where the need to avoid ‘cover-ups’ may require surprise audit.

3. Use of reference standard and chacklist. the auditor is expected to compare activities as they are with some objective standard of what they should be. If such standard are available, there is less need for the auditor to make a subjective judgment, less opportunity for wide differences of opinion.

The refference standard normally available:• Writen policies of the company as they apply to quality• Stated objectives in the budgets, program, contracts, etc.• Customer and company quality specifications• Pertinent government specifications an hand books• Company, industry and other pertinent quality standard• Published guides for conduct of quality audit• Pertinent quality department instruction• General literature on auditing

• One type of checklist identifies areas of subject matter which are to be checked, the auditor: to supply the detailed checklist

• In some companies the checklist go into great detail, requiring the auditor to check numerous item of operational performance, as well as the records.

4. Verification of facts: Auditors are expected to review with the line supervision of facts of any deficiencies discoverred during the audit. The facts should be agreed on before the item enters a report

5. Discovery of Causes: The auditor is expected to investigate major deficiencies in an effort to determine their causes. This is the basis for recommendation.

6. Recommendation and remedies: Auditors are exected to make recommendation with a view to reducing deficiencies and improving performance, but are told to avoid becoming involved in designing remedies. However auditors are expected to follow up recommendations.

Policies often incorporated into a “Quality Audit Manual”

7. Human Relations in Auditing

• Auditors are human beings, their relation with whose work is being audited can become quite strained. This important to warrant extensive discussion with respect to:– Reason behind audits: this need to be informed to

manager, supervisor and non supervisors– Avoiding an athmosphere of blame. Audit report and

recomendation should be object oriented rather than person oriented

– Balance in reporting– Depersonalizing the report.– Postaudit meeting

8. Audit Reporting• Audit results should be documented in a report, and draft should be

reviewed with the management of the activity that was audited. The report may be jointly issued by auditor and auditee.

• The report should include:– Purpose and scope of audit– Details of the audit plant, including audit personnel, dates, the activity

that was audited (personnel contacted, material reviewed, number of observation made, etc). Detailed should be placed in appendix

– Standard checklist, or other reference document that were used during the audit

– Audit observation, including supporting evidence, conclusion and recommendation

– Recommendation for improvement opportunities– Recommendation for follow up on the corrective action that is to be

proposed, along with subsequent audit if necessary– Distribution list for audit report

9. Essential ingredient of a Quality Audit Program• An uncompromising emphasis on conclusion

based on facts• An attitude of auditors that the audit not only

serve to provide assurance to management, but also as useful service to line manager in managing their department.

• An attitute of auditors to identify opportunities for improvement

• Addressing the human relation issues as discussed

• Competence auditors.

10. Quality Surveys• Audit are concerned almost exclusively with

conformance of various sort: conformance of plant to standard of good planning, and conformance of execution to plan. These audits are not sufficient to provide full assurance to upper management, since they are not concerned with:– Relative standing in marketplace with regard to quality– Analisys of user’s with respect to cost, convinience etc.– Opportunities for reducing cost of poor quality– Challenge to product development– Challenge to top management with respect to policies, goal

premises and axiomatic beliefs– Employee perception on quality

• These missing element require broader view than structured audit. This often called ‘quality survey’, quality assesment, or companywide audit.

• The survey can be accomplised in several ways:– Using an overall framework which include an assesment of both

quality results and quality system. Companywide assesment consist of:

• Cost of poor quality• Standing in the marketplace• Company culture on quality• Assesment of current quality activities

– Assessing quality using published criteria which emphasis on quality results, such as: MBNQA.

– Assessing quality using published criteria which emphasis on defined element of quality system , such as ISO 9000

– Assessing the quality system using criteria developed whithin a company for use in evaluating its own operations.

– Assessing the quality system using criteria developed whithin a company for use in evaluating supplier

• In a different survey, a consultant was asked to define specific task responsibilities in the quality program. The consultant used 5 questions to interview the department managers:– What task in your department affects quality?– Should any additional quality related tasks be performed in your

department?– Should any additional quality related tasks be performed

anywhere in the company?– What quality related tasks have unclear responsibility?– What quality related tasks currently done in your department

require more definitive writen procedure?• Findings: the cunsultant summarized the findings as

follows: the quality program consisted of 178 tasks in 26 functional areas, responsibility of 19 tasks was not clearly defined, and for 27 quality related tasks the managers expressed concern about clarity of the tasks.

11. Product Audit

12. Sampling for Product Audit

13. Reporting the results of Product Audit