Category 1
Is the CA responsible for inputting the documentation into a Waiver?
No; the CA is responsible for verifying the information and reviewers once it has been documented.
True or False – A person should sign off for two different roles within an ECR as long as their name is listed as a reviewer for both of those roles.
False; only one signature signoff per person. The reason being, there is more than one set of eyes viewing the object.
Does the CA "implement" the new changes into the system?
No; it is the responsibility of the team assigned to the ECR/ECO.
How is the priority of an ECR determined?
A.) Based off of the set stipulations detailed in AQS 255. The Implementation Priority.
B.) It is whatever the Initiator wants to set it as.
C.) Based off of work load/product necessity.
D.) The CA picks the priority based off of the Initiator.
A.) Based off of the set stipulations detailed in AQS 255. The Implementation Priority.
True or False – The CAs only support Memphis based Engineers.
False; we have users from around the world. And not only engineers (all different braches of the company)
What is the purpose of the CM Highlights?
To keep our users informed of important information, key features, changes to process, provide ongoing training of the ECR/ECO process, invite users to a hands on training, and make the CA team more approachable.
When does Regulatory enter the comments into an ECR?
Prior to the ECR going to Submit.
True or False – The CA is responsible for “pushing” objects to SAP?
True – If, for some reason, the object is not appearing in SAP the CA has to go and manually push it to SAP. (each one)
What object is used to release New Product introduction into the system?
An ECO is created by the CA.
Then prior to Releasing, the CA will verify that the Matrix Structure is accounted for and properly exist in SAP.
True or False – The CA must verify all Routing changes within SAP prior to approval.
True; Matrix doesn’t track routings so the CA has to make sure that the changes have been correctly set up. We are the second set of eyes.
At a minimum, how many Matrix Queries do CAs run on a daily basis?
A.) 1
B.) 2
C.) 3
D.) 4
C.) 3
What is a CA’s main role in audits?
Dedicated document retriever. However, we help with copy/stamp/staple, running, and chat.
What are the five main aspects of an ECR that the CA must verify for correct completion, prior to the ECR’s promotion?
A.) Title, Description, SDOC, Initiator Name, and GDOC
B.) Change Rationale, GDOC, V and V, Regulatory Comments, and SDOC
C.) Technical Reviewers, Manufacturing Statement, Management Reviewers, Implementation Rationale, and Edit Comments
D.) There aren’t five aspects of an ECR.
B.) Change Rationale, GDOC, V and V, Regulatory Comments, and SDOC
(refer to AQS 6699)
If an ECR has to be demoted for any reason, does the CA have to re-review the ECR in its entirety?
Yes, because once the ECR is demoted it becomes editable again and changes can be made that were not part of the original submission.
What is the max number of revisable objects that should be connected to an ECR?
No more than 50; it becomes difficult to review that many objects in one sitting and something could be missed.
*If more than 50 are needed, then the CA must be contacted for approval.
Can a CA sign off on an ECO containing a document if the Form 01982 for Training Effectiveness has not yet been completed?
No; we have to connect the sketch to the ECO before we can approve the ECO for release.
What all must CAs provided to the Legal Department for legal matters when asked?
A.) Legal Never asked the CAs for anything
B.) The CAs are only responsible for showing Legal how to use Matrix.
C.) All objects associated with a certain product. (including all Revisions and any ECRs/ECOs)
C.) All objects associated with a certain product. (including all Revisions and any ECRs/ECOs)
What spec can you find the Form # that has the template for creating new Work Instructions?
AQS 0000001
On average, how many ECOs do CAs process (complete) in a month’s time frame?
A.) 610
B.) 230
C.) 150
D.) 95
B.) 230
On average, how many ECRs do CAs process (complete) in a month’s time frame?
A.) 250
B.) 50
C.) 610
D.) 195
D.) 195