QMS Folders
ISO
QMS Documents
Training
C/PARs & Internal Audits
100
Can you name the 6 high level ISO folders?
QMS, ADMIN, QRST, PRO, Liasion, Team
100
What does "ISO" stand for?
International Organization for Standardization. * We will pass certification for ISO Standard 9001:2008 in November
100
What is a Peer Review Form?
This form is used to review your co-worker's document changes.
100
Who is responsible to ensure procedures are current? How would you know if an update is needed?
It’s everyone’s responsibility. When you are doing your daily reviews and noticed that a change in the process has occured.
100
Double Points!! Are C/PARs preventable? If so, how?
Yes
200
What does "MCQM" stand for?
Medi-Cal Quality Management
200
Should your SOP be open during an audit/review? Why?
Yes.
200
Should your procedures reflect current process? What if it does not?
Yes. It is your responsibility to update the SOP.
200
Double Points What would be your evidence that you were trained?
The Training Log and Training Evaluation Form.
200
What does "C/PAR" stand for?
Corrective Preventive Action Report
300
Where can you find the SOP Assignment List for QRST?
(T:\4 - MCQM QRST\4-1 Reference ) It provides names of the analyst assigned to a specific SOP update. That analyst is responsible for ensuring the SOP reflects the current process(s).
300
Is continual improvement part of ISO standards?
Yes. If you have a process improvement idea, please let your team and leader know. This could be added to the Process Improvement Log by submitting a Change Request Form.
300
Double Points!! Should a document that does not have a header and footer reference be saved in ISO folders?
No. The exceptions are "For Reference Only - External documents".
300
Where would you find the MCQM Training Procedure guidelines?
T:\1 - MCQM QMS\1-2 Process-Procedures
300
How do you prepare for an audit? What would be the first thing you need to do?
Read your SOP. Make sure you understand the process. Ask questions if needed for clarification. Review the MCQM Internal Audit Schedule and Metrics to view the documents to be audited and the associated ISO clauses.
400
Where can you find the Document Review Schedule and how are you notified that a review is due?
T:\1 - MCQM QMS\1-1 Reference. The Document Control Manager (aka Lily) notifies the team via e-mail.
400
Double Points What do you do when you see a document misplaced in a folder?
Notify your leader and the Document Control Manager. Adjust the speed of your mouse if necessary. Use caution when moving documents. Never delete a document unless it's in your WIP folder.
400
Name a form that you currently use to create/add a document?
The Document Record Request Form which will be merged with the Change Request Form shortly.
400
Who is responsible to ensure the Training Evaluation Form is completed?
The trainee and trainer.The form is completed by a trainee.
400
When are C/PARS initiated? a) When there is a nonconformity b) To initiate preventive measures to avoid possible future nonconformities. c) A & B
C
500
Double Points!!!! Where is the Formal Peer Review Form located? When would you use it?
T:\1 - MCQM QMS\1-3 Forms. On a new document/process or if there are significant changes to an existing document/process.
500
How do you meet the MCQM Quality Policy and Objectives?
By complying with the quality policy and objectives stated: on time delivery of weekly and monthly reports, review processes at least once a year, etc. This document should be posted in your cubicle. This is also located in the Quality Plan Handbook and on the shared drive at: T:\1 - MCQM QMS\1-1 Reference\MCQM Manual.
500
How do you know if a document was updated?
Look at the Revision History. You should always use the most current version on the shared drive. Delete any old templates from your WIP folder. Do not re-use saved documents.
500
Can a process be measured?
Yes. By using the Performance Assessment Form and through internal audits.
500
Why do we receive C/PARs?
When there is a nonconformance to an ISO clause(s)
M
e
n
u