Show:
Introduction and BBQ
Implementing 1
Implementing 2
Error proofing
IMS y Change Management
100
Culture and Built in quality
What is the PQA Foundational Principles?
100
- Product Design - Training - Order & Schedule - Raw Material - Negative Flow
What are the Plant wide systems?
100
- Process Setup Verification - Post Run Quality Verification - Parameter Control - Process Alarm - Parameter/ Surrogate Alarm
Which are the process specific systems?
100
- Mechanical fixtures - Sensors and detectors - Transactionals tools - Checklists - Second checks
What are types of Error Proofing?
100
Provides a communication layer between plant wide systems and manufacturing processes.
What is an Integrated Manufacturing System?
200
- Assuring Product Integrity - Understanding Process Capability - Controlling Process Inputs
Which are the three components of PQA?
200
- Red: Inadequate or no controls in place - Yellow: Manual or visual measurement and Alarm/Paper verification or surrogate measurements - Green: Automated measurement and alarm/Error proof verification
What are the control levels/What are the base for the control % of a process?
200
5) Identify process variables for CTQ’s 6) Implement controls for process variables 7) Confirm controls improve capability 8) Eliminate Inspections, scrap, rework
What are the steps to implement “built in” controls?
200
Is based on functions: process, perception, selection, memory, motion
What is an error?
200
Advanced level of IMS and fundamental support systems are required.
What is one of the Level 4 or Gold requirements?
300
- Culture - Change Management - IMS Information Flow - Process Specific Systems - Plant Wide Systems
What are are the five design elements of PQA in CCS?
300
1) Identify critical to quality (CTQ) 2) Confirm ability to measure the CTQ 3) Measure Process Capability vs. Target 4) Inspect incapable CTQ’s
What are the steps to assure product integrity?
300
Tool to define product critical to quality characteristics
What are CTQ tree and Operational Definition table?
300
- Potential Error Identification - Solution Generation - Solution evaluation and selection
What are the steps to integrate error proofing into PQA?
300
Revision requirements for New Product Introduction in Stages 2, 3 and 4.
What are the Quality Process Plan and IVTP?
400
A) Broken window theory: When small things, such as a window, are left broken and unrepaired an underlying signal has been given that these activities are okay, Such chaos leads to complacency and acceptance of mediocrity B) Is the cornerstone of PQA and allows us to drive fear out of the culture because true continuous improvement is realized by attacking the variation, not by “blaming the operator”.
What are Physical and Behavioral environments?
400
Tools that help to identify process variables for the CTQs and helps to implement controls for those process variables (uses in steps 5 and 6)
What are the Parameter Matrix and the Built In Quality Control Plan (BIQCP)?
400
Evaluate new control effectiveness by: - Capability change in CTQ - Use of statistically based sampling plan - Analyze Impact and update RPN Value
How to confirm that controls improved process capability?
400
- Ideal Final Result (IFR) - Scientific effects - Solutions Direction Worksheet (TRIZ)
What are the Solution Generation techniques?
400
They can be used to stablish initial process capability based on statistically valid sampling plans.
What is IVTP?
500
Operator doesn’t realized that he is making a negative impact into process or product quality
What is a Process induced or Unintentional Negligence cause?
500
Y = f (x1, x2, x3…… x4)
What formula represents PQA? Y = CTQ X = Process inputs/variables
500
Process inputs or process variables
What are the process X’s? X = Process inputs
500
Error Proofing principles
What are Elimination, Replacement, Facilitation, Detection and Mitigation?
500
- Performance attributes - Specifications and tolerances - Measurements systems and methods - Sample size and frequency - Data storage location
What are some components of an IVTP?