Audit Technique
Documents/Records
Edstrom Processes
ISO Clauses
KPI's
100
Is what is written next to each answer to show the questions was asked and responded to
What is documented evidence?
100
Is less detailed and describes the overall process versus a more detailed and in-depth explanation of each step.
What is the difference between an SOP and a WI?
100
The document that shows the main and support process utilized at Edstrom.
What is Edstrom Process-Based Quality Management System?
100
To approve document prior to use, review and update as necessary, ensure current revision and changes are identified, relevant versions are available at point of use, legible, distribution controlled, prevent use of obsolete documents.
What is Control of Document (4.2.3)?
100
Has 4 sections: 1 showing the Pareto of the top issues, 1 showing a chart of the yearly data, 1 showing the data, and 1 with the continual improvement.
What is a 4-panel chart?
200
To review past audits and detemine additional questions for the upcoming audit.
What is audit preperation?
200
Is an electronic repository of documents and records utilized by Edstrom.
What is SharePoint?
200
Consist of 25 top level processes which include Main Processes, Support Processes and Managerial Processes.
What is Edstrom Process-Based Quality Management System?
200
Top management ensures that customer requirements are determined and met with the aim of improving customer satisfaction through monitoring customer perception.
What is Customer Focus (5.2 or 8.2.1)?
200
Is a visual indicator of how well the process is performing compared to a pre-determine goal.
What is a process measure?
300
To ask questions that require more than a yes or no answer.
What is an open ended question?
300
A record that is signed by either a trainer or manager and the employee show that the employee is either a trainee, competent or a master in a given area or skill.
What are training records?
300
A process for designing and approving new production machinery, tooling, and processes.
What is Design of Manufacutring Processes
300
Edstrom taking action to eliminate the causes of nonconformance in order to prevent recurrence.
What is Corrective Action (8.5.2)?
300
4-panels or process measure are reviewed before the audit to see if the process is meeting or not meeting the goal and what is being done if it is not being met.
What is KPI review during audit preparation?
400
To allow the auditee proper time to respond and looking at the auditee in the eyes when receving the response.
What are good listening skills?
400
A spreadsheet in SharePoint (D-000080) that list each record, retention time, storage, location, disposal method, and who is in charge of the record.
What is Edstrom Record Retention document?
400
A procedure that applies to all internal and external corrective and preventive actions; encompassing the entire process from initiation to closure and pertains to all parties involved.
What is Corrective and Preventive Action process?
400
Edstrom determines, collects, and analyzes appropriate data to show the suitability and effectiveness of the quality management system (QMS).
What is Analysis of Data (8.4)?
400
Is used to show Management how the process is performing comeared to the the goal.
What are Edstrom's process measures?
500
To review the procedure and all related documentation ahead of time.
What is audit preparation?
500
Control of Documents, Control of Records, Internal Audit, Corrective Action, Preventive Action, and Control of Nonconforming Material.
What are the 6 clauses that require a procedure?
500
A procedure that identifies, contains, and segregates non-conforming purchased and manufactured products found in the Manufacturing, Assembly, Service/Installation, and Customer locations.
What is Control of Nonconforming Product?
500
Edstrom identifies and reviews changes to verify, validate, and approve design and development changes before implementation.
What is Control of design and development changes (7.3.7)?
500
Used to show how the process is performing compared to goal. Red is below goal, yellow is meeting goal and green is above goal.
What is stop light color coding.
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