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Internal Auditing Audit

Revision: a

Plan - Audit Preparation
Audit Date:		Lead Auditor:
Other Auditors:		Clause:	9.2 Internal Auditing
QA Manual Rev:		QA Manual Clauses:
List other applicable documents, Process Owner and Inputs:	Process Inputs: Internal Audits, Nonconformances
Do - Compare Documentation vs. Requirements
Read the applicable sections of documents listed above and compare to the clauses of the QMS standard.
QUESTION		YES / NO / N/A	EVIDENCE / NOTES
In general, does the documentation meet the requirements of the QMS standard?		Yes No N/A
Review Customer requirements that may be applicable. In general, does the documentation meet Customer requirements?		Yes No N/A
Review statutory and regulatory requirements that may be applicable. In general, does the documentation meet regulatory requirements?		Yes No N/A
Improvement Suggestions:
Check - Compare Actual Practice vs. Requirements
Compare the requirements of documents referenced above against everyday practice of employees.
CLAUSE	QUESTION	YES / NO / N/A	EVIDENCE / NOTES
9.2	a) internal audits are performed at planned intervals	Yes No N/A
9.2	b) internal audits determine whether the QMS is effectively implemented and maintained	Yes No N/A
9.2	b.1) the QMS conforms to planning requirements - standards and Company requirements to:	---	---
9.2	1) determine appropriate quality objectives and requirements for the audit	Yes No N/A
9.2	2) establish appropriate processes - documents and provide resources	Yes No N/A
9.2	3) determine appropriate verification - validation - monitoring - inspection and test and criteria for audit acceptance	Yes No N/A
9.2	4) determine appropriate records for the internal audit process and maintenance of records	Yes No N/A
9.2	c) audit planning defines the considerations taken for the status and importance of QMS processes - audited area and the results from previous audits	Yes No N/A
9.2	d) audit planning defines the criteria - scope - frequency and methods of performing the audit	Yes No N/A
9.2	e) Auditor selection and the performance of audits ensures objectivity and impartiality of the audit process	Yes No N/A
9.2	f) Auditors do not audit their own work	Yes No N/A
9.2	g) an audit procedure is documented that defines the responsibilities and requirements for planning - performing - reporting and for maintaining audit records	Yes No N/A
9.2	h) the responsible manager ensures actions are taken without undue delay to eliminate nonconformances and their causes	Yes No N/A
9.2	i) follow-up activities include verification of actions - reporting of verification results and defines requirements for:	---	---
9.2	1) reviewing actions taken to eliminate the cause of nonconformances to prevent recurrence	Yes No N/A
9.2	2) determining that corrective action is appropriate to the affect of the nonconformance	Yes No N/A
9.2	3) review of nonconformances and Customer complaints	Yes No N/A
9.2	4) determination of the cause of nonconformance	Yes No N/A
9.2	5) evaluation of the need for action to ensure nonconformances are not recurring	Yes No N/A
9.2	6) determination and implementation of necessary action	Yes No N/A
9.2	7) recording the results of actions	Yes No N/A
9.2	8) reviewing corrective actions	Yes No N/A
9.2	j) planning of the internal audit uses ISO 19011 for direction	Yes No N/A
9.2	k) detailed tools and techniques are developed - such as check sheets - process flowcharts or any similar method to support audit of the quality management system requirements	Yes No N/A
9.2	l) selected internal audit tools are effective in measuring the overall organization performance	Yes No N/A
9.2	m) internal audits meet contract and/or regulatory requirements	Yes No N/A
Review previous audits and RFS's against this process - add comments below.
Comments:
Act - Verify the Effectiveness of the Process
Review the applicable process map.
QUESTION		YES / NO / N/A	EVIDENCE / NOTES
Are the inputs accurate and complete that are listed on the process map as compared to actual practice?		Yes No N/A
Are the inputs being properly provided to the process operators? Are individuals competent and trained in the process? Do individuals understand the quality policy?		Yes No N/A
Are the process steps accurate and complete as compared to true practice? Who supports this process and how does this process support other processes?		Yes No N/A
Are there sufficient check steps (inspections, tests, reviews, approvals, sign-offs, etc.) to ensure the outputs meet requirements before passing onto the next process?		Yes No N/A
Does the process appear controlled, understood and adequately meet the requirements of applicable documentation?		Yes No N/A
Are process objectives defined, measured and understood?		Yes No N/A
Does the process appear effective in meeting those objectives and is there continual improvement?		Yes No N/A
Provide brief details on any areas that were found to be well-implemented, particularly effective or worth noting as positive traits of the process. List records reviewed - attachments A/R.
Summarize Observations and Findings for RFS System
Summary:
Check One:	Documentation does not meet the standard Documentation does not match actual practice Practice does not meet the standard Practice does not meet documentation requirements Document control issue Minor error(s) in document Other
Explain Other:
Opportunities for Improvement
Summary:
Check One:	Documentation could be improved Practice could be improved Documentation and Practice could be improved Other
Explain Other:
Review and Submit Audit Report
All auditors on the audit team must submit their audit reports for summary and review by the lead auditor.
Lead Auditor:	Review the completeness of this report prior to submitting it to the Quality Manager. Be sure findings show objective evidence, everything is written clearly and all checklist questions are answered.
Lead Auditor Name:		Date:
Deliver Audit Report to Appropriate Managers
Send Report To:	Accounting Manager Administrative Assistant Contracts Manager EHS Manager Engineering Manager Facilities Manager Human Resources Manager Manufacturing Manager Plant Manager Purchasing Manager Quality Manager R&D Manager Other
Explain Other:

PaperlessEfficient QMS™Created by: qualitycontrolplan.com

Internal Auditing Audit

Paperless
Efficient QMS™
Created by: qualitycontrolplan.com