Audits

Presentation by: Suresh R. Norman SSN College of Engineering

Objectives
To understand what is the importance of Audits in an ISO standard Quality system

Audits
After all the Quality policies and procedures and work instructions have been implemented, it is required to check if the results are in agreement with the expected performance. This checking process is what 'Audit' is all about. All process elements should be audited at least once a year.

5 Objectives of Internal Audits

Determine if actual performance conforms to the documented QMS. Initiate corrective action activities in response to deficiencies Follow up on non-compliance items from previous audits Provide continued improvement in the system through feedback to management Cause the auditee to think about the process,thereby encouraging possible improvements

Auditor
Audits, whether internal or external audits,
should be done by qualified staff who have received training in auditing principles and procedures. Auditor should be a good listener, and good at oral and written communication skills besides being aware of the ISO standards. Auditor should be objective, honest and impartial, and be able to separate fact from fiction or fact from superfluous or redundant information

Audit procedure
An audit plan and check-list is prepared by the auditor Audit plan indicates the department to be audited, should list the procedures, documents, and regulatory requirements involved, and the audit team and who receives the audit report. Checklists ensure that the right questions are asked, based on the procedure and instruction being audited. This ensures the audit is more efficient.

3 parts of Audit
(1)Pre-audit meeting here the audit process and time-table are discussed and previous audits are reviewed. Minutes of the pre-audit meeting and attendees are recorded and included with the auditors documentation.

 (2)Audit the auditor asks questions of the process owners etc. in the area being audited. It gives a picture of the state of the system.The auditor notes the conformances and non-conformances and whether procedures need to be modified,improved. The nonconformities observed and identified must be tagged with a code number and be described as accurately as possible , including where it was observed,evidence of nonconformity The aim of the audit is continuous improvement and increased customer satisfaction.

(3)Audit -closing meeting

At the closing meeting, the lead auditor presents a summary of the audit findings, along with the supporting evidence. The audit closing meeting is minuted, along with the list of attendees and the date of final report submission is decided.

Audit report
Has a cover sheet that shows the audit date,names of audit team members, areas audited, reference number , signature of lead auditor,etc. Lists the nonconformances and copies of all the nonconformance reports. Outlines procedures for corrective action and follow-up tasks.

Question
Why is auditing done in a quality system? What is the method by which auditing is done?

References
Dale H. Besterfield et al., Total Quality Management, Pearson Education LPE