INTEGRATED SOLUTIONS
QUALITY SYSTEMS AUDIT PROCESS
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Prepared By: |
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Lead Author, Integrated Solutions |
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APPROVED BY & AFFECTIVE ON DATE OF SIGNATURE BELOW: |
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Yufen Chang Yu, Integrated Solutions |
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THIS DOCUMENT IS TO BE REGARDED AS THE official QUALITY SYSTEMS AUDIT PROCESS within Integrated Solutions. IT IS TO BE MAINTAINED UNDER CHANGE CONTROL BY the document control coordinator.
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CHANGE SHEET |
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TITLE: Integrated Solutions Quality Systems Audit Process |
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DESCRIPTION OF CHANGE |
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ISSUE |
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SECTION |
DESCRIPTION |
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1.0 2.0
3.0
3.1
3.2
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3/9/97 6/27/97
5/22/2000
2/15/2002
2/17/2006 |
All 5.0
5.0
6.0
5.0 |
Original issue. Added escalation methodology.
Changed Internal Audit frequency to Bi-annually
· Updated list of documentation.
· Correction - each process should be audited at least once per 18 months instead of 12 months.
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Table of Contents
1.0 DESCRIPTION.....................................................................................................................................................
2.0 PROCESS OUTPUT............................................................................................................................................
3.0 CUSTOMER.........................................................................................................................................................
4.0 SUPPLIER............................................................................................................................................................
5.0 DETAILED PROCESS DESCRIPTION..........................................................................................................
6.0 AUDIT RECORD KEEPING PROCEDURE..................................................................................................
7.0 RECORD RETENTION......................................................................................................................................
7.1 Purpose..............................................................................................................................................................
7.2 Policy Statements...........................................................................................................................................
APPENDICES...........................................................................................................................................................
1.0 Description
The process is a formal examination of an organization's quality system to gather information in any of the following areas:
Quality Management System's overall achievement of stated quality objectives
Adherence to certification specifications
Adherence to documented processes and procedures
Documentation of all performed processes and procedures
The use of Closed Loop Corrective Action (CLCA) techniques to eliminate process problems
Customer/supplier management
This process may be triggered by the requirement to conduct regularly scheduled internal audits. For internal audits, the process includes developing an internal audit schedule. All internal audits will be formally transcribed. The training records will be kept by the Project Specialist.
2.0 Process Output
Process output is a timely, written report which must satisfy the informational requirements of the triggering input. Process conformance data is collected and reported on a regular basis by the Document Control Coordinator.
3.0 Customer
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Customer # |
Customer |
Customer's Need(s) |
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1 |
Certification Organization |
A complete, accurate audit report that provides information as specified. An audit schedule based on the status and importance of activities being audited. |
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2 |
Integrated Solutions Employees |
A complete, accurate audit report that provides information specified in written request. |
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3 |
Integrated Solutions ISO 900 Champion |
A complete, accurate audit report that provides information specified in written request. |
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4 |
Integrated Solutions Auditee |
A complete, detailed audit report assessing the Quality System. |
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5 |
Integrated Solutions ISO 900 Champion |
A complete, detailed audit report assessing the Quality System. |
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Customer # |
Process Management Provided By Your Customer |
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1–5 |
Feedback about satisfaction with the audit report |
4.0 Supplier
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Supplier #
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Supplier |
Items supplied |
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1 |
Standards Bodies |
Quality standards and specifications. |
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2 |
Client |
A completed audit request. |
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Supplier #
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Process Management Provided to Specific Supplier Control Points |
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1 |
A request for additional information, when required. |
5.0 Detailed Process Description
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Responsible Position Name |
Task # |
Detailed Process Description All Tasks (Subprocesses) and Measurement Points |
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Lead Auditor |
1
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Develops internal Audit Schedule according to the following guidelines: Processes identified as critical to Integrated Solutions customer satisfaction receive highest priority on the schedule. Processes improved through the work of Process Action Teams or Problem-solving Teams should be audited subsequent to changes. Large, cross-functional processes should have priority as performance of these audits requires more time and resources. Overlap with external audit schedule should be avoided. Each process should be audited at least once per 18 months. |
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Lead Auditor |
2 |
Assigns auditors to each scheduled unit. In order to ensure audits are independent and objective, auditors cannot audit their own department or functional area. In addition, if auditors from inside the Integrated Solutions Quality Audit team are used for first party (internal) audits, their relevant training experience must be requested and scrutinized by Lead Auditor. This is to ensure that the auditor has experience in both the area being audited and the audit standard (e.g. ISO 9001) used. Formal audit training for non-Integrated Solutions auditors is preferred; however, extensive knowledge in areas mentioned and practical audit experience may be deemed sufficient. |
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Lead Auditor |
3 |
Lead Auditors response for letting the ISO 9000 Coordinator if team member cannot make schedule. |
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4 |
Notifies auditee (7 days) in advance of audit. |
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Audit Team |
5 |
Gathers information (reports, documents, etc.) required to conduct audit. May include meeting with auditee. |
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6 |
Organizes information and develops checklist to perform the audit. |
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7 |
Determines assignment of responsibility among audit team members. |
CONTINUED. . .
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Responsible Position Name |
Task # |
Detailed Process Description Describe All Tasks (Subprocesses), Process Management and Measurement Points |
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Audit Team |
8
9
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Performs the audit and ensures the auditee understands and accepts any non-conformities found. Summarizes audit results in report highlighting any corrective (and preventive) action required by the auditee. Writes report using Internal Audit Report Forms. If a quality standard is used (e.g. ISO 9000), categorize non-conformities as major or minor, the definitions of which are: major: a significant non-compliance with the standard requirement; or a failure of a complete system or the lack of a quality management system requirement. minor: an isolated, witnessed accident of failure to comply with a procedure or quality management system requirement; or a minor problem area which warrants attention. |
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Lead Auditor |
10 |
Conducts closing meeting with auditees. Presents all discrepancies found and any other notes in the audit report. Audit Report will be ready with the Auditee within a week. |
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11 |
Places copy of audit report in Internal Audit Notebook in the ISO 9000 Coordinator’s office. Distributes copy of audit report to each member of Integrated Solutions Audit Team involved in audit. |
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Auditee |
12 |
Prepares corrective action plan within three weeks of receiving the audit report to address each audit finding. Must conform to Corrective Action Report. |
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Lead Auditor |
13 |
Monitors completion of corrective action plan. Escalates status of overdue corrective action plans to CEO/President. Reviews corrective action plans to ensure inclusion of all necessary information in the plan. |
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Auditee |
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Informs Lead Auditor when corrective action plan is implemented. Verifies analysis and correction of each audit finding. |
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Lead Auditor |
15 |
Notes corrective action completion in audit record and Lead Auditor verifies the corrective action. |
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Categories of measurement |
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[ ] Process Conformance [ ] Process Efficiency [ ] Yield [ ] Product/Service Conformance [ ] Other |
[ ] Throughput or Volume [ ] Schedule or Timeframe [ ] Cost [ ] Improvements
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Measurement Point # |
Metric |
Metric and Measurement Point Description, with Frequency of Measurement, Reporting and Report Recipients Noted |
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M1 |
Bi-annually |
· Bi-annual assessment of the efficiency of the audit program, value add and review of overdue internal audit action items will be conducted during the Quality System Management Review.
Escalation will be made to upper management by the lead auditor as soon as a corrective action becomes overdue. Missed milestones due not need to be escalated unless impacting the overall completion date.
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6.0 Audit Record Keeping Procedure
Record keeping for Quality Audits proceeds as follows.
Prior to start of audit, the Lead Auditor:
Works with audit team to update audit schedule as necessary
Leads audit team in developing checklist for audit
At completion of audit, Lead Auditor:
Dates audit report, places the due date for the corrective action plan on the audit finding report, makes a record copy and presents the original to auditee in a closing meeting
Records audit completion date, audit report date and closing meeting date in audit file log
Records audit completion date on audit schedule
Records the date corrective action plan was reviewed
Records date corrective action was completed
Maintains a copy of the following documents in the Internal Audit notebook located in the ISO 9000 Coordinator’s office:
- Audit Findings by Year
- Corrective Action Reports by Year
- Findings Summary Sheet by Year
- Audit Schedule by Year
7.0 Record Retention
7.1 Purpose
The purpose of this policy is to ensure that records are systematically maintained and deleted in accordance with a predetermined, approved plan. Compliance with this policy will guarantee records are available when required for management use and to comply with regulatory agencies. In addition, the audit file log will demonstrate that Integrated Solutions utilizes established procedures for disposing of audit records in an orderly manner within the normal course of business with no intention of destroying records to conceal possibly unfavorable information.
7.2 Policy Statements
All quality audit records will be stored in a designated filing area by the ISO 9000 Coordinator.
An audit file log will be maintained identifying:
Areas audited
Audit completion dates
Audit report dates
Closing meeting dates
Corrective action plan dates
Corrective action completion dates
All audit records will be retained until January of the year following the second anniversary of the audit report, unless they must be retained longer to fulfill any appropriate regulatory requirements.
Appendices
Quality Audit Flowchart
Lead Auditor Tasks Flowchart
Quality Systems Audit Forms
QUALITY AUDIT FLOWCHART
Lead Auditor Tasks Flowchart
* There may be more than one Lead Auditor