Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Scope of Audit
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Comments:
Opening meeting
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Complete attendance register
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Signatures of attendees:
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Objectives of the audit.
-Not to reject the system
-re-currence may point to system failure
- cant cover all aspects.
-where no non-conformance detected does not mean non exist sample of activities -
Review of audit programme:
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Review of audit programme:
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Company representative :
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Company representative :
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Function of company representative:
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Time of closing meeting:
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Confidentiality:
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Reasons for aborting audit:
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Scoring
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Audit scoring legend: 0 = Not addressed at all 1 = No evidence of effective application ( even if implemented) 2 = Implemented / partly implemented 3 = implemented -partly implemented 4 = fully implemented and effectively applied
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Clarification of findings: 0 = Red (No) - System deficiency - action plan approved and monitored by SHEQ department 1 = Red (No) - Finding - (<5 requires action plan) 2 = Red (No) - Finding 3 = Red (No) - Observation 4 = Green (yes) - conforming - No finding
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Invite questions:
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Comments:
Overview of organisation:
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Comments:
Process Metrics - Clause 4.1. e/f and 8.2.3
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What metrics do you keep to evaluate the effectiveness of this process?
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Evidence:
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Who looks at these metrics? How are they evaluated ? Do you have any goals or objectives established?
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Evidence:
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Are goals and objectives being met? (Pull records to verify whether or not any goals are being achieved.)
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Evidence:
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If goals are not being met, ask:) what actions are being taken to improve the process? (Review records to verify at actions are being taken. These actions may be documented on action request, in meeting minutes, and so on)
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Evidence:
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If applicable interview any internal customers of the process to determine if the process is effective
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Evidence:
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Final Comments:
Responsibilities , authorities, competence, awareness and training - clause 5.5.1; 6.2
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Who participates in this process? (Record those positions that was interviewed
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Evidence:
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How are responsibilities and authorities defined and communicated for these personnel (These may be in job descriptions, documented procedures or work instructions, and so on. Verify throughout the audit that defined responsibilities and authorities are clearly understood. Note any exceptions
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Evidence:
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Has the organization defined the skills and knowledge (competence) required to perform the jobs in this process?
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Evidence:
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Where applicable is training then provided to ensure that employees are competent? What does this process look like?
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Evidence:
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Pull training records for employees, either new to the organization or new to the position. Be sure to pull records for management, technical and admin staff, as applicable for the process, as well as operators, maintenance and QA. Complete the training matrix at the end of is checklist
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Evidence:
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How is training evaluated for effectiveness? (Pull records and verify conformance) . Is there anything that should be done to make the training process more effective? (Note any opportunities for improvement to the right)
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Evidence:
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(Interview the new employees. Ask the following questions:) <br>a) how would you rate the training process on a scale of 1 to 10? (If 7 or below, ask more questions) what specific knowledge did you need that was not provided? (Verify that specific training was, in fact, not provided. Note the opportunity for improvement) <br><br>b) what training did you wish you bad recieved? Did lack of that training create a problem for you? Record opportunity for improvement
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Evidence:
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Final comments:
Information required for the process - clause 4.1.d, 4.2.1 and 4.2.3
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What types of documents are used in this process? (Record these on the attached document contort matrix. These may include procedures, work instructions, test methods, job descriptions, specifications, prints, check sheets, batch sheets, contort plans and so on.)
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Evidence:
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Interview auditees to verify that the documents include the right amount of information. Sample questions might include the following:) <br><br>a) Were you trained by your procedures and instructions?<br>b) if so, were they helpful to you? <br>c) if not why not, are they too long? To short? Obsolete? Wrong? <br>Records opportunities for improvement
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Evidence:
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Compete the document control matrix to verify control of necessary documentation
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Evidence:
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During the audit were any obsolete or invalid documents noted in areas where the document is used? Look particularly at bulletin boards, postings on wall or near equipment and so on
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Evidence:
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Verify that documents of external origin are identified and that their distribution is controlled. List those documents that are verified. External documents may include legal and regulatory requirements, OEM equipment manuals, customer specifications, international and industry - specific standards and so on
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Evidence:
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What other information is required for this process? (Depending on the process being audited, this may include work orders, inventory levels, POR, production schedules, sample schedules, audit schedules, etc.)
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Evidence:
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Does the information include everything that you need? Is it correct? Do you get it when you need it?
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Evidence:
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Comments:
Equipment, tools, parts, materials, hardware software required for the process - clauses 6.3 and 6.4
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What equipment, tools, parts, materials, hardware or software are required for this process?
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Evidence:
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Is equipment adequately maintained? Are there any repetitive equipment problems?
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Evidence:
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Are tools adequate for the process?
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Evidence:
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Are tools adequate for the process?
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Evidence:
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Are there any repetitive problems associated with any materials used in the process?
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Evidence:
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Are materials available when needed?
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Evidence:
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Is any software used in the process adequate to meet the needs of the users?
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Evidence:
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Is the work environment suitable for the process?
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Evidence:
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Final comments:
Control of records -clause 4.2.4
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(Through-out the audit, verify hat records being presented to the auditor have been identified as records in procedures or other documentation. Note any exceptions.
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Evidence:
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Through-out the audit, verify that records are legible, readily retrievable, and stored in a way that protects their fitness for use. Have responsibilities for record collection and maintenance been clearly defined and documented? Are they understood?
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Evidence:
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Where records are stored electronically, are they backed up regularly to prevent their loss?
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Evidence:
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Verify that records maintained in long term storage are stored and filed in a discipline manner.
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Evidence:
Policy statement and supporting objectives: communication - clause 5.3; 5.5.3 and 6.2.2.d
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Interview personnel throughout the audit. Ask the following questions: a) are you aware of the quality policy? Can you state the key concepts in your own words? How does the quality related to your job? b) what goals / objectives have been established for this process? Are we achieving our goals? How does what you do impact whether or not we will meet these goals? (Verify that goals and objectives have been communicated to personnel in this process)
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Evidence:
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Final comments:
Control of measuring and monitoring devices - Clause 7.6
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Describe the calibration process at your site. Does it include both process and product testing equipment? Does the calibration process include any quality-critical equipment owned by others?
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Evidence
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Are standards use to calibrate instruments traceable to a national standard? If not is the basis used for calibration clearly documented. (Pull certificates of traceability - or other basis for calibration - for five standards used in the calibration process)
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Evidence:
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(Through out the audit, look for instruments that were found to be out of calibration when they were initially checked. Verify that an assessment of both previous results took place and that appropriate action was taken with both the instrument and any products that may have been tested with that instrument)
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Evidence:
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Were any instruments repetitively found to be out of calibration? If so has corrective action been initiated to resolve the problem?
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Evidence:
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Through out the audit, verify that instruments and standards are handled in a way that protects their fitness for use. Verify that they are protected against adjustments that would invalidate calibration settings. Note any exceptions.
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Evidence:
General requirements - measurement, analysis and improvement - clause 8.1 -and 8.5.1
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Describe the processes at the site to continually improve the effectiveness of the QMS. What evidence of improvement can you give me.?
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Evidence:
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What statistical tools are used to analyze data? (Verify tools are being use correctly)
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Evidence:
Customer satisfaction - Clause 8.2.1
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How does the site measure and monitor your customers perception of you ability to meet their requirements? May I see it please (verify that data is being collected in accordance with the plans)
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Evidence:
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Who evaluates this data and determines whether or not action is required? (Verify that responsibility to imitate corrective action or preventive action is clearly defined and understood.)
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Evidence:
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What action is been taken based on this information? (Review records showing evidence that any appropriate action is been taken)
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Evidence:
Analysis of non-conformances -Clause 8.3, 8.4 and 8.5.2 .a
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How are product or service non-conformances tracked and monitored for opportunities to reduce them? ( Pull corrective actions where indicated and verify that actions are being taken to reduce non-conformances.)
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Evidence:
Corrective action - Clause 8.5.2
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How does the corrective action process work? (Who initiates, who evaluates? Who tracks them? Who verifies making sure as having been effected?
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Evidence:
Preventative action -Clause 8.5.3
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How is preventative action identified and documented at your organization? Verify that there is a process to identify proactive, preventive actions.
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Evidence:
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Pull three records of preventive action and verify conformance to documented procedures.
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Evidence:
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In the past year what specific improvements to the site have resulted from the corrective and preventive action process?
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Evidence:
Summary of audit report:
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Summary of total score:
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List non-conformances:
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List points / areas / clauses for improvement/s:
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List observations:
Purposed corrective action dates:
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Purposed corrective action dates:
Signatures
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Auditor's signature
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Auditee signature
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Management representative signature:
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Lead Auditor signatures
