Technical Audits

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TECHNICAL AUDIT www.rsjqa.com

Transcript of Technical Audits

TECHNICAL AUDIT

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INTRODUCTION

• Audits are normally designed for one or more of the following purposes

– To determine the conformity or nonconformity of the quality system elements with specified requirements

– To determine the effectiveness of the implemented quality system– An opportunity to improve the quality system, to meet regulatory

requirements

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TECHNICAL AUDIT

• A technical audit is an audit performed at a company or manufacturer where the auditor, engineer or subject matter expert (SME) evaluates deficiencies or areas of improvement in a manufacturing process, system or proposal.

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WHO IT IS FOR?

• This is required for a customer who sources or imports goods from – new supplier or– new product from existing supplier

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RESPONSIBILITY

An Auditor,– is knowledgeable and trained in

quality system requirements, including internal audits

– initiates all internal audits and ensures they are conducted in an efficient and timely manner

– monitors corrective actions

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ASPECTS COVERED

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General techniques in conducting audit, • Opening Meeting• Observation of Work• Interviews• Document Review• Closing Meeting

OPENING MEETING

• Opening meeting takes place in the presence of factory management representative/ factory representative.

The auditor will explain– purpose of the audit– audit agenda– audit result grading system and reports/forms

to be used– the need of cooperation by the factory people

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OBSERVATION OF WORK

• Observation of work includes manufacturing,

– Process– Procedure– Process control– Workplace condition– Production lines– Major machines(machine/equipment name and quantity)

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INTERVIEW

• A face to face interview with the employee to know proceedings of the manufacturing unit.

• Employee interviewed in the absence of management people.• Employees are interviewed about the work condition of the

manufacturing unit.

Examples: • Are those quality objectives measured periodically (e.g. daily, weekly,

monthly)?• Does the factory store inventory in an appropriate environment and safe

condition?• Does the factory monitor, control and record all applicable process

parameters?

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DOCUMENT REVIEW

• All the documents related to factories systems and procedures are verified.

• Document review helps to know factories,

– Business license– Product certificates– Pay rolls and attendance record– Environmental certificate– ISO 9001 certificate

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CLOSING MEETING

• Closing meeting takes place with the senior management / factory representative.

• All documents related to the audit, including checklists, deficiency reports and corrective action responses are discussed.

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USEFUL LINKS

• For further information

http://www.rsjqa.com/inspection-services/loading-inspection

• To Download our service confirmation form http://rsjqa.com/useful-corner/downloads

If you have any queries or need sample CLI report feel free to contact us at

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THANK YOU

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