i-QUALITY
Quality is only owned by site QA leader
False.
Everyone owns the quality
Double Jeopardy !!!
What are the top QRL that OX needs to work on
Consumer complaint
Process control includes,centerlines, control charts, Proficy alarms and_________
control strategy
You have quality near miss on your lines or machines. What system do you have to capture the quality near miss?
Quality alert
Double Jeopardy !!!
Following ______ is similar to following traffic rule
SOP
Risk prediction numbers are used to determine the quality risk based on RPN total value (T/F)
True
DOUBLE JEOPARDY !!!
What are some examples of losses related to Initiative Delivery?
All of the above
When you start your shift, you must complete this and lead the discussion ? If it is M/H risk, you need to develop _____
Quality trigger list.
Countermeasure to mitigate the quality risk
Double Jeopardy !!
what is the purpose of control strategy?
trouble shooting guideline to get process/quality back on track
Double Jeopardy !!
What are the key methods to drive out losses related to change over QRL
Double Jeopardy !!!
Why Quality is tied to CBN and TSR?
Money!
poor quality---> lose market share---> total sales drop---> margin goes down
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
Double Jeopardy !!!
Name several examples of GMP technical standards that we use everyday
raw materials quality assurance
-record-keeping of substances throughout the manufacturing process
-standards for cleanliness and safety
-qualifications of manufacturing personnel
-in-house testing
-production and process controls
-warehousing and distribution
Double Jeopardy !!!
If quality is out of control, what system do you refer to in order to make the CL move?
Control strategy
Double Jeopardy !!!
______ is one of UPS tools (troubleshooting), comprised of 5M
Fish bone
Machine
Material
Human
Environment
Procedure
Double Jeopardy !!!
What are key in process measures and output measures for the system that you own?
In process measures : material quality, QA check, centerline, control strategy, SPC alarm, Line clearance, BOM verification, RLS, CIL etc
Output measures: QI, unplanned hold, ELP, production cases, PR
Double Jeopardy !!
When you find the oil contamination from PRs that you make, what do we need to do?
1. Notify your machine PE
2. Place PRs on hold
3. Contact CVTG lines to place FP on hold as necessary
4. look for the source of contamination and fix the issues
Double Jeopardy !!!
What is the name of tool that helps get down to the root cause and develop the countermeasure for QI?
Y-Y
DOUBLE JEOPARDY !!!
You just found that you have a QI on your machine or lines. what are the steps to take?
1. Place the affected products on hold
2. Report QI to your day shift resources
3. Document what happened in QA data base
4. Document cause and countermeasure on shift log if available
DOUBLE JEOPARDY !!!
The 4 classifications of Quality Incidents are Inadvertent Shipment and Damage/Degradation after shipment, and _____ and _____
Contamination, inappropriate release
During the unexpected DT tied to proficy, what are the steps you need to take from PMKG and CVTG?
1. Manual check on test sheet
2. Work with Day shift resource to transcribe info on Proficy
3. Create QA for this
Double Jeopardy !!!
Definition of SQI
Significant quality incident. Anything greater than 250K
safety and regulatory issues
Double Jeopardy !!!
When do you respond SPC violation? What is the purpose of SPC control
Blue font, salmon background - out of control
Red font, white background – out of specification/reject
helps us deliver the best quality results for the consumer and minimize risk of quality issues
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 blowdown on your lines or belt changes on your machines 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
What are the names of tools required to close out QI? These tools are important in terms of identifying the root causes and thus preventing the reoccurrence.
6W2H and Y-Y