Title Page

  • Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

General Instructions

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

Management Planning

  • 1. Are processes defined, linked and identified?

  • 1.1. Is the trend of characteristics monitored.?

  • 1.2. Are the required results being achieved?

  • 2. Is there an organization chart?

  • 2.1. Does it list positions not names?

  • 2.2. Does it distinguish levels of management?

  • 2.3. Are responsibilities assigned?

  • 2.4. Does it outline authority from top down?

  • 3. Are Job description available?

  • 3.1. Do they list requirements and responsibilities?

  • 3.2. Is there an employee listing?

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

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

  • 5. Are the interested parties listed?

  • List objective evidence . .

Controls

Process Controls

  • Is there a flow chart for all identified processes?

  • Are inspections or measurements points identified?

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

  • Is there a control plan?

  • Do the inspection or measurement points match flow charts?

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

  • Is there a floor diagram?

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

  • Is there a nonconforming area designated on diagram?

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

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

Measurement / Testing

Measurement & Testing

  • Are there procedures established for testing and measuring?

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

  • What is measured?

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

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

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

  • Are critical characteristics defined?

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

Cutomers

Customer Process / Service

  • How are the customer requirements documented?

  • How are the related documents controlled?

  • What is the approval process of customer requests?

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

Processing

Processing

  • Are operator responsibility established and defined in procedures?

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

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

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

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

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

Corrective Action

Corrective Action

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

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

  • What type of problem solving techniques are in place?

  • Is there a schedule of maintenance of equipment?

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

  • Are traceability procedures understood by employees ?

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

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

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

  • What type of reward is given for approved suggestions?

Analysis

Analysis

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

  • How is customer satisfaction measured

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

Supplier

Supplier

  • Are purchased items checked for compliance?

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

  • Is there an approved supplier or outside contractor list?

  • Why type of approval process is used?

  • Describe the frequency of re-approval process?

  • Are there any on site quality audits of suppliers?

Signature Page

  • Auditor Completing Audit

  • Site Representative

  • Comments (as applicable)

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.