The main purpose of planning is to provide a program to measure conformance to a company with engineering and quality requirements. Audits are subject to control and must meet principles of efficiency and economy. Once plans and schedules have been established, procedures are written and approved. Audit Checklist and Guidelines.
What is an Audit?
A quality audit is an independent evaluation of various aspects of work performed. The purpose is to provide information to those in need. An audit is a professional evaluation of the processes to determine the degree of compliance.
Why are audits performed?
Audits are performed to verify, by examination and evaluation, whether certain applicable elements of engineering/quality have been effectively implemented by specific requirements.
An audit is a systematic prevention/appraisal activity that examines the policies, practices, records, and general activities to determine their adequacy about a predetermined goal. Audits are performed to detect problems/deficiencies before the conditions deteriorate, Briefly, audits help to:
• Measure quality through observations.
• Detect errors and trends
• Keep a process under control
• Identify areas where special attention is required
• Judge the adequacy of the plan.
Quality audits are comparable to accounting audits that verify a company's assets by issuing reports to pinpoint problem areas.
Who performs an audit?
Normally a process or a product audit program is administered by a quality organization. For example, the quality engineering group plans to write procedures to perform an audit and the quality control organization implements the plan and performs audits.
Team audits are performed by representatives from quality groups, manufacturing, products engineering, and product assurance functions with the quality group representatives acting as team leaders.
Audit Programme Problems
The following are some of the problems that audit programs may encounter.
(i) Failure to heed the previous audit reports
(ii) Insufficient skill and knowledge of auditors.
(iii) Inadequate training of auditors.
(iv) No value-added perspective.
(v) Lack of technical details in reporting.
(vi) Too many disciplinary discrepancies.
(vii) Abrasive relationship between auditors and line managers. And Lack of correlation between audit results and process yields.
A sure way to cause deterioration of human relations is to look for scapegoats instead of solutions. With systematic audit planning effective feedback tracking and training programs, these problems can be eliminated.
Elements of an audit system
Audits are usually structured to carry out planned goals and are conducted under specific rules. Because audits are the basis for a good deal of managerial action, they are entrenched with many rules of conduct to ensure objectivity and validity. Due consideration should be given to planning since planning is a prerequisite for directing and controlling audit activities. Some of these activities include.
• Strategic points where audits can be performed.
• Audit frequencies.
• Audit procedures/approach: sample size and tools to be used.
• Training requirements.
• Audit classification and criteria.
• Verification of factual findings.
• Audit result analysis and reporting.
• Subsequent follow-up on plans for corrective action.
• Escalation procedure.
• Database and historical evolution.
The scope and objectives of audits can influence the frequency of auditing. In principle, new systems, procedures, operations, and products will be subject to a relatively high audit frequency until users of gain sufficient confidence.
Types of Audits
Audits can be divided into two types, Routine audits, and Team audits.
Routine Audits
Routine audits are sometimes called periodic or scheduled audits (Internal Audits) and are performed on a daily/weekly scheduled basis by quality control personnel who are part of the organization.
Team Audits
Audits can be periodic but random and unscheduled. Team audits performed in conjunction with manufacturing and other engineering personnel can alleviate many problems. Representatives from manufacturing, quality engineering, test engineering, purchasing, or other disciplines may join as team members. A quality engineering representative acts as team chairman. Team audits should be performed at least once a year.
An auditing team is formed for one particular audit assignment or project, but the quality control department is a permanent organizational unit designed to manage and administer audits.
A sub-system of the Audit program
Quality personnel may be called upon to perform the following types of audits.
Process Audits
Process audits consist of verifying the process flow of a product, ensuring that the process is capable of producing a product as intended. That is individual process steps, as well as the aggregate of steps, produce the product as required.
Equipment / Tester / Tool Audits
Audits for equipment, testers, and tools are performed to verify the settings, calibration procedure/intervals/status, associated software, performance, adequacy of preventive maintenance, and the capability of producing the desired product. Specification limits are checked and assurance is obtained that the intended purpose is served; that is, a defective product is not accepted and a good product is not discarded.
Operator Audits
Operator audits make sure that operators follow the procedures and understand the basic process/product flow. These audits are not intended to provide data on worker performance.
Documentation and Records Audits
These kinds of audits are necessary to ensure conformance to current practices. Documented changes are normally made through process change notices or bulletins. Process change notices are generated as a result of reactions to problems or improvements made to enhance the yield, quality, or reliability of the product. No matter how a change is made, an unbroken audit trail of the original process must exist quality assurance must check the documents for the following criteria.
- Existence of adequate job instructions.
- Availability of documents for line personnel.
- Standardized documents.
- Clarity and accuracy content.
- Process operating documents.
- Calibration and monitoring documents.
- Maintenance manuals.
- Process control charts.
- Environmental recording charts.
- Experimental work procedures.
- Rework procedures.
- data recording and logbooks.
Data records are objective evidence of performance and conformance. Records of product measurements, schedule, visual observations, work-in-process, etc.
Calibration and Standards Audits
Standards audits indicate the type of available standards on the manufacturing floor and traceability requirements of the standards. Standards are used to verify tester and equipment's settings and monitor their performance against a known value. Workmanship standards in the form of photographs or artifacts are provided as a visual aid to the operators.
A calibration audit is an independent unbiased audit to verify that the equipment and tester used to produce a product have been calibrated and are not overdue for calibration. audits are performed to verify the existence of calibration procedures and the degrees to which calibration intervals are met.
Product Audits
Product audits are performed to make sure that components meet the intended specifications.
Process Control status Audit
Process control status audits are verified through control charts. Control charts are observed for any noticeable trends and are then checked for accuracy to make sure that these charts are current.
Environmental Audits
Environmental audits are performed to verify acceptable levels of temp., humidity, cleanliness, vibration, and noise are maintained and, in addition, that work areas are kept free of static charges through proper grounding procedures.
Chemicals and materials Audits
Chemicals/materials audits are performed to ensure that the right types of chemical materials are used and that the shelf life of the chemical has not expired. in addition, the audits make sure that adequate care is being used to prevent chemical hazards.
Vendor Purchased Parts / Components Audits
These types of audits are performed to ensure that acceptable quality level parts and components are used and that they can be traced to the original source in case of a problem. And Software system audits.
Concluding and Remakes
with an effective audit program, problems should be detected early. The general purpose is prevention. Good audits are the key to productivity. The aim of the audit is to remove deficiencies by taking corrective actions and identifying opportunities for improvements. An experienced and alert auditor is often able to discover opportunities for improvement as a by-product of his or her search for discrepancies.
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