Internal Audits

Information

Audit Description:
Audit Conducted on
Prepared by:
Report Date:
Report issued To:
Corrective Action:
Personnel Interviewed
Documents Referenced

8.2.2 Internal Audits

Is an internal audit system in place to determine whether the QMS: a) Conforms to planned arrangements (including customer contractual requirements), to requirements of the standard, and to the QMS requirements established by your company. b) Is effectively implemented and maintained?
Are they being performed on time? Are they effective? Do they identify good improvements and eliminate nonconformances?
How is the audit schedule prepared? Is it taking into account the conditions listed in the standard, including: • Status and importance of the area • Results of previous audits What is included in the audit plan?
What measures are in place to ensure the audits and auditors are objective and impartial in the audit process and do not audit their own work?
Is there a documented procedure and does that procedure define the responsibilities and requirements for planning and conducting audits, including audit reports and maintaining records?
How does the management responsible for the area audited take timely action to eliminate nonconformities and their causes?
Do follow up activities include verification of the corrective action and the reporting of those results?
Evidence

QOP-82-02 Rev E

1. Internal Audit Schedule /Plan

1.1 Business Systems is responsible for scheduling internal quality audits. Each key process comprising the quality system is audited at least once per year. Some processes are audited more frequently, depending on their status, importance, and audit history. Internal Quality Audits Operational Procedure: QOP-82-02 Revision: E Page 2 of 2 B&B Manufacturing The internal audit plan is a matrix listing processes being audited and the estimated audit dates. Several units may be clustered into one audit as they apply to each other and/or departments affected, such as key processes noted with the turtle diagrams. Is this complaint? Please Include Evidence.
1.2 The internal audit schedule is discussed periodically in management reviews and is flexible to accommodate changing priorities. Is the Internal Audit discussed in Management Reviews? Please Include Evidence.
2. Audit Tools 2.1 The audit tools used to support and guide the auditors in performing audits may include: check sheets, turtle diagrams, flowcharts, customer/industry references, etc. Is it evident that some of this tools are being used?
3. Audit Team 3.1 The Business Systems team facilitates the internal audits and the training. Personnel performing the audits shall be independent from the process/department being audited. Are the Auditors independent from the process/department being audited?
3.2 Internal auditors are trained in auditing tools and techniques prior to performing internal audits. Training records are maintained in Human Resources. Are Training Records in HR?
4. Preparing for Audit 4.1 Auditors prepare for an audit by reviewing applicable procedures, past audit reports and customer and industry requirements.
5. Conducting and Reporting the Audit 5.1 The supervisor responsible for the area being audited is contacted in advance with the audit timeframe. Are Supervisors notified in advance with the audit timeframe?
5.2 While conducting the audit, auditors seek objective evidence demonstrating whether the audited activities conform to the requirements of the documented quality system, and whether the system is effectively implemented and maintained. When nonconformity is noted, it is brought to the attention of the responsible supervisor.
5.3 At the conclusion of each audit, an audit summary report is developed by the auditor and reported out to applicable supervisors / management.

6. Corrective Action and Follow-up

6.1 Once a nonconformance is identified and documented, a corrective action request is generated. Upon receiving the report, the responsible manager investigates to determine the root cause and implements corrective action.
6.2 CARs are due in 10 business days. If more work is needed to fully implement the action, a new follow-up date is agreed upon.

7. Documentation and Record

7.1 Internal audit results, including corrective actions, are documented and maintained by the Business Systems Department.
7.2 Audit summary reports established during the cycle are compiled, analyzed, and are presented at the management review meeting.
Documents Referenced:
Evidence
Personnel Interviewed