Internal Process Audit of Quality Management System

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

General Instructions

• For every question answered yes: list evidence observed, along with procedure numbers or standard reference, as applicable.

• For every question answered no: create or design plan to correct and prevent re-occurrence, create project in CAPASL database.

• For every question answered Non Applicable: describe and or define reason.

• Retain audit report in SG-1 ; AIMS ; Internal (1st Party) under site being audited.

• Notify AIMS group of audit reports so all can benefit from observations.

• Local management review of all audits are required.

Management Planning

• 1. Are processes defined, linked and identified?

  Yes

  No

  N/A

• 1.1. Is the trend of characteristics monitored.?

  Yes

  No

  N/A

• 1.2. Are the required results being achieved?

  Yes

  No

  N/A

• 2. Is there an organization chart?

  Yes

  No

  N/A

• 2.1. Does it list positions not names?

  Yes

  No

  N/A

• 2.2. Does it distinguish levels of management?

  Yes

  No

  N/A

• 2.3. Are responsibilities assigned?

  Yes

  No

  N/A

• 2.4. Does it outline authority from top down?

  Yes

  No

  N/A

• 3. Are Job description available?

  Yes

  No

  N/A

• 3.1. Do they list requirements and responsibilities?

  Yes

  No

  N/A

• 3.2. Is there an employee listing?

  Yes

  No

  N/A

• 3.3. Does it define who is qualified for what job?

  Yes

  No

  N/A

• 4. Is there any link from local procedures to corporate procedures or policies?

  Yes

  No

  N/A

• 5. Are the interested parties listed?

  Yes

  No

  N/A

• List objective evidence . .

  Documents

  Interviews

  Observations

Process Controls

• Is there a flow chart for all identified processes?

  Yes

  No

  N/A

• Are inspections or measurements points identified?

  Yes

  No

  N/A

• Is there a Failure Mode Effect Analysis completed products or processes or service?

  Yes

  No

  N/A

• Is there a control plan?

  Yes

  No

  N/A

• Do the inspection or measurement points match flow charts?

  Yes

  No

  N/A

• Is there a plan of reaction for out of conformance?

  Yes

  No

  N/A

• Is there a floor diagram?

  Yes

  No

  N/A

• Do inspection or measurement points match flow chart and control plans?

  Yes

  No

  N/A

• Is there a nonconforming area designated on diagram?

  Yes

  No

  N/A

• Are there any process controls in place (I.e. Statistical Process Control)?

  Yes

  No

  N/A

• What is level and trend of Cpk on critical characteristics?

  Yes

  No

  N/A

Measurement & Testing

• Are there procedures established for testing and measuring?

  Yes

  No

  N/A

• Is there a calibration program of gages and test instruments?

  Yes

  No

  N/A

• What is measured?

  Select pressure size chemical shape service time cost

  • pressure
  • size
  • chemical
  • shape
  • service
  • time
  • cost

• What is the verification process of gages or test instruments?

  Yes

  No

  N/A

• Is there a prescribed schedule of verification and calibration of gages or test intruments?

  Yes

  No

  N/A

• What or how are calibrations linked to known national or international standards?

  Yes

  No

  N/A

• Are critical characteristics defined?

  Yes

  No

  N/A

• What is reaction is measurements don't measure up?

  Yes

  No

  N/A

Customer Process / Service

• How are the customer requirements documented?

  Yes

  No

  N/A

• How are the related documents controlled?

  Yes

  No

  N/A

• What is the approval process of customer requests?

  Yes

  No

  N/A

• How does information flow from approval to production, purchasing, testing, etc.?

  Yes

  No

  N/A

Processing

• Are operator responsibility established and defined in procedures?

  Yes

  No

  N/A

• Are quality procedures and policies current and known by employees?

  Yes

  No

  N/A

• Are nonconforming products and or services procedures in place and followed?

  Yes

  No

  N/A

• Is there a Material Review Group (MRG) or similar team to make decisions on nonconforming products or services?

  Yes

  No

  N/A

• Are guidelines for MRG or similar teams in place and are they followed?

  Yes

  No

  N/A

• Are there waiver compliance rules in place and are they followed?

  Yes

  No

  N/A

Corrective Action

• Are there procedures for the control of nonconforming materials and or services?

  Yes

  No

  N/A

• Is there a correction and corrective action system in place?

  Yes

  No

  N/A

• What type of problem solving techniques are in place?

  Yes

  No

  N/A

• Is there a schedule of maintenance of equipment?

  Yes

  No

  N/A

• How are materials or services traced throughout processes to end user?

  Yes

  No

  N/A

• Are traceability procedures understood by employees ?

  Yes

  No

  N/A

• How are materials or technical data preserved or stored or prevented from damage?

  Yes

  No

  N/A

• Is correction and corrective action done in a timely manner on audit findings?

  Yes

  No

  N/A

• Is there a means for employees to make suggestions for improvement?

  Yes

  No

  N/A

• What type of reward is given for approved suggestions?

  Yes

  No

  N/A

Analysis

• Are internal or self audits conducted on the quality management system or identified processes at prescribed intervals?

  Yes

  No

  N/A

• How is customer satisfaction measured

  Yes

  No

  N/A

• Is data collected and analyzed to demonstrate the effectiveness of present processes and procedures?

  Yes

  No

  N/A

Supplier

• Are purchased items checked for compliance?

  Yes

  No

  N/A

• Is purchased information reviewed and approved prior to release of Purchase Orders?

  Yes

  No

  N/A

• Is there an approved supplier or outside contractor list?

  Yes

  No

  N/A

• Why type of approval process is used?

  Yes

  No

  N/A

• Describe the frequency of re-approval process?

  Yes

  No

  N/A

• Are there any on site quality audits of suppliers?

  Yes

  No

  N/A

• Auditor Completing Audit

  Sign

• Site Representative

  Sign

• Comments (as applicable)