| Standard Operating Procedure |
| Title: | Internal Audits |
SOP-0049 Revision: 10 |
| Department: All Area: |
Approved & Released Standard Operating Procedure |
| Document Type: Quality Procedure Standard Element: ISO 9000 - ISO9001: 1994 4.17 Internal Quality Audits |
Review Period - 364 Days |
1.0 Purpose:
To ensure the requirements of the ISO Standard are met and that all employees are following procedures of the Quality System.
2.0 Scope:
That audits to the Quality System are completed once a year (more if necessary) in order to ensure the system is working and also to implement corrective or preventative actions if there are any problems
3.0 Responsibilities:
The Internal Audit Team is responsible for conducting all Internal Audits which includes the Internal Assessment database in our Lotus Notes Quality System. Management will review all findings and actions related to Internal Audits.
4.0 Definitions:
5.0 Procedure:
Quality System functions shall be audited once a year and more frequently as required based on status and importance. The schedule of audits will be completed by the Quality Manager and kept in the QSI System. Audits are conducted by individuals who have the following qualifications:
General knowledge of company operations
Prior audit experience
External formal ISO training and/or on-the-job training
Internal audits have a lead auditor to document the entire audit and another to assist in the process. Auditors continue certification after they conduct three audits annually as lead auditor. After completion the training coordinator is notified and a training record is recorded.
Internal Audits will be done in accordance with the written procedures and checklists which are found in the Quality System database. Audits should be led by an individual not directly related to the function being audited. Auditors will review revisions to the ISO Standard to assure the AMCOR Quality Manual and related procedures have been updated to comply with the change. The following documents are used in the audit process:
Previous audit findings
A copy of the procedure
Internal Assessment checklist
Previous Corrective Actions (QIR's from past audits)
All audits are to be assessed the day they are scheduled and discussed in the following weeks' Quality Assurance meeting. If an Internal Auditor is busy at the scheduled time of an internal audit they are required to consult Senior Management concerning priority. If work prevails over the internal audit, the Quality Manager is notified by Senior Management and reschedules the internal audit.
Auditors will review the procedure noting if there have been any revisions (section 9 ) from past audits or internal QIR's. The revisions are checked to insure effectiveness. While the audit is performed all activities done correctly are noted as Compliant. The actual operations or areas checked will specifically be denoted in the column provided. During the audit all Non Conformities are identified as Non Compliant or Needs Improvement. These observations will also be entered in the column provided describing exactly what the deficiency was. Additionally, for all findings either MINOR or MAJOR a QIR will be created and if a specific person is at fault they are required to sign off on the QIR. Auditors are responsible for the following QIR details:
Summary of Problem
Action Taken
QIR re-check on the NDATE (Next Date - notified automatically through Email
Root Cause Analysis
Verification of Effectiveness
Employee sign off (if required)
Close out the QIR when issue is resolved
The lead auditor will report to Quality Assurance by creating the following documents:
Internal Assessment Findings
QIR's
Report (summary)
It is encouraged that the audits contain recommendations for improvement and not be limited to only non-conformities. Areas which are deficient and need corrective action are noted with a QIR #. The QIR # will be on the findings sheet and forwarded directly to management for review. This is a method for management to take immediate action if required.
Internal Audits are reviewed in the weekly Quality Assurance Meeting. The QIR's and the Report (summary) are reviewed. If necessary a meeting will be held with departments or employees effected. If there are adjustments, procedural changes or anything which requires corrective action it is noted on the QIR. QIR's can to viewed in the AMCOR Computer System (SAS 8.4) by category.
Resolution date for QIR's is based on the importance of the issue. If there were changes to any particular procedure it will be re-audited at a date designated by the lead auditor. This time frame will ensure the new changes have been implemented and effective.
6.0 Safety & Environmental Information:
7.0 Associated Documents:
8.0 Document Revision History:
| Revision: 10 |
Date Created: 11/03/99 Date of Last Revision: 04/23/2003 |
Last Approval Date: 04/23/2003 |