i-QUALITY
QRL
Q system
Q behavior
Other topic
100

What does I quality mean to you ? 

Everyone owns the quality 

100

What are common quality losses from your operation area? 

1.Consumer complaints

2.Finished Product Hold for Quality Defects

3.Raw Material Quarantine/Hold for Quality Defects

4.Over pack and Yield

5.Rework and Reprocessing

6. Scrap - Broke

100

Process control includes, _____, control charts, Proficy alarms and control strategies.

centerlines 

100

You have quality near miss on your lines or machines. What system do you have to capture the quality near miss 

Quality alert 

100

There is no tolerance for falsification of documents 

T/F

True 

200

What is the system 1 on I -quality program? 

Leadership 

200

DOUBLE JEOPARDY !!!

What are some examples of losses related to Initiative Delivery?


  1. Product made that fails to meet ok to ship criteria
  2. Qualification fail and sampling must continue
  3. New standards not delivered or understood
  4. Process definition fails to deliver repeatable centerlines

All of the above

200

What do you call " quality system failure" that causes >250K losses to the company and create consumer safety and legal concerns ? 

SQI = significant quality incidents 

200

Explain how you find the control strategy on your lines or machine? 

Proficy link or L drive 

200

What are the key methods to drive out losses related to change over QRL 

  • Follow documented changeover procedures
  • Execute your quality check when coming up from the changeover
  • Quality checks are done on the defined frequency
300

How Quality is tied into O-TSR? 

Money !

300

_______    Form is needed for the ______SPOC to begin an investigation into Mate a material defect.


A completed Raw Material Complaint 

Material system 


300

DOUBLE JEOPARDY !!!!

What is the name of the system that your PP or PE evaluate on a weekly with you at shift change meeting? 

Finished product quality (FPQ) health check 

300

If quality is out of control, what system do you refer to in order to make the CL move? 

Control strategy 

300

_________ are system failures that are caught early and prevented a loss.

Quality Alert

400

How many systems are there on I -quality program?  What system do you represent? 

8 systems,  5 from making and 6 from packaging and labeling 

400

After a change over, you do a Sheet Count Quality Check. When you entered the value in Proficy, there are no specifications for Sheet count.  what do you have to do? 

You should stop line and not run until Sheet count is verified with Leadership/QA.

400
What are two examples of troubleshooting tools? 

6W2H, y-y 

400

DOUBLE JEOPARDY !!!

Following standards is critical in GMP. Name several examples of standards we use on the operation floor 

SOPs, CO check list, start up CBA, control strategies 

400

DOUBLE JEOPARDY !!!

The 4 classifications of Quality Incidents are  Inadvertent Shipment and Damage/Degradation after shipment, and _____  and _____

Contamination, inappropriate release 

500

DOUBLE JEOPARDY !!!


Tell me where you can find WQA and OX plant policy? 

Link on Oxnet Q section  

500

Tell me top 3 CC focus area that OX is working on

Missing perf, Contamination, Odor, Product stuck together due to too much tail seal glue 

500

If you find the quality defects from poly materials that you just receive, what are steps that you need to take? 

fill out Raw material complaint form and give it to your PP or SPOC

500

 What is the first thing we typically do when you start your shift? _______

Several hours later after you begin your shift , you find that there will be a massive overhead blow down. What will be your actions? 

Quality trigger list 

1. Escalate Quality risk on trigger list

2.  Clear the products from the accumulator, packing loop

3. Keep vigilant about the SOC issues  


500

What are names of tools required to close out QI?  These tools are important in terms of identifying the root causes and thus preventing the re- occurrence. 

6W2H and Y-Y 

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