Patient Impact
Every product we manufacture ultimately affects whom?
What is the patient
What should you use to cross out an error in a record?
What is: A single line
This type of document is formally approved and managed so employees can access the authorized version.
What is a controlled document
This system is used by employees to complete required training on controlled MPS documents.
What is MolexEDU (Learning Management System)
When a product, process, or procedure does not meet a requirement, it may be considered this.
What is a nonconformance
True or False: Quality is primarily the responsibility of the Quality Department.
What is False. Quality is everyone's responsibility.
This principle means quality records must be accurate, complete, and trustworthy.
What is data integrity?
The software system(s) used to view/find controlled documents such as work instructions or SOPs.
What is SAP, MDS or MII.
True or False: Its a requirement to complete required training in MolexEDU before performing work that affects product quality.
What is True
In MPS, this SAP problem report is used to process different types of quality problems.
What is a Quality Notification (QN)
This is the most important reason we follow procedures and work instructions.
What is to ensure patient safety and ensure consistent product quality.
True or False: It's acceptable to modify data in SAP or on paper without a justification in the long text or as a footnote?
What is false
You notice the work instruction at your workstation does not match the current approved revision. This should be your next action.
What is stop and verify the current approved document before continuing?
In MolexEDU, this area allows employees to see training they have previously completed.
What is Learning History
You discover product that may not meet requirements. Your first priority is to prevent it from being unintentionally used or shipped. This action is called what?
What is containment
An employee discovers a potential defect that could affect a device already distributed to customers. The employee should do this rather than assume someone else will handle it.
What is promptly escalate and report the concern through the appropriate process?
Before walking away from your computer or workstation, taking this simple action helps protect company and confidential information.
What is locking your computer screen or logging out?
This process ensures proposed document changes are reviewed, approved, and implemented in a controlled manner.
What is document change control
Employees should check MolexEDU regularly for these, especially when controlled documents or training requirements change.
What are new training assignments
This problem-solving technique repeatedly asks a simple question to help identify why an issue occurred.
What is the 5 Whys
Name one way your role contributes to patient safety.
What is:
Following procedures, completing training, reporting issues, documenting data correctly and timely.
An electronic record shows the final result, but the history of changes is missing. This electronic control helps show who changed the data, when, and what changed.
What is an audit trail?
In SAP, this master record stores information about a controlled document, including its document number, revision, status, and metadata.
What is the DIR number. (Document Information Record number.)
If you believe you will not complete required training by its due date, you should speak with this person before the training becomes overdue.
Who is your supervisor/manager
Before suspect product associated with a QN can be unblocked/released, this must be obtained.
What is disposition approval?