APPRAISAL QUALITY COSTS

• Inspection/Testing of Incoming
• Materials
• Inspection/Testing of In-process
• Materials
• Inspection/Testing of Finished
• Products
• Lifetime (Stability) Testing

INTERNAL FAILURE QUALITY COSTS

• Rejects
• Reworks
• Re-inspections
• Retests
• Wastage
• Trouble shooting
• Sorting Substandard Materials
• Morale

EXTERNAL FAILURE QUALITY COSTS

• Product Recalls
• Product Complaints
• Product Returns
• Company Reputation

BASIC TOOLS FOR QUALITY ENHANCEMENT

• Separation of Powers
• Forms – Internal paperwork
• Specifications
• Vendor Auditing
• Statistical Sampling
• Pareto Analysis – Where to begin
• Statistical Process Control
• Dialogue

BUILDING/ENVIRONMENT

• Buildings
• Re packers, remanufactures, contract sterilizers and Relabelers.
• Contamination controls
• Orderly operations

Environmental controls

• General controls
• Analyze operations
• Specifications
• Monitoring

Environmental controls

• Contamination controls
• Personnel sanitation practices
• Prevent contaminations by hazardous substances
• Personal practices

CLEAN ROOM

A room of which the concentration of airborne particles is controlled to specified limits.

• An enclosed space
• Class
• Controlled Conditions - Temperature, Humidity, Positive Pressure

Clean room

• Controlled entry
• Eating, drinking and smoking
• No lead pencils
• Storage of glassware and utensils
• No cardboard

Clean room

• Regular cleaning
• Proper furniture
• Control of air quality
• Maintaining filters

CLEAN ROOM : CLASS

CONTAMINATION

Machine etc. = 5 %

Air-bourn = 10%

Human = 85%

Particles Generation Rate

• Idle = 0.1 M
• Work Bench = 1 M
• Walking = 5 M
• Heavy Exercise = 25 M

HUMIDITY

• Absolute humidity
• Relative humidity
• Temperature-humidity Index (THI)

THI = [(DB + WB) x 40%] +15

If 70 : All comfortable

75 : 50 % comfortable

79 : All uncomfortable

FLOW OF AIR

• Air Changes = 30-60
• Fresh Air = 10 %
• Positive pressure= 1.2-2.5 mm
• Pressure drops

Microvee filter = 6-7mm H2O

HEPA filter = 25 mm H2O

Air velocity = 50-150 ft/m

PARTICLE CALCULATION

(Clean room size = 1000 sqft)

No. of people = 33

Generation/person = 5 M/min

Human contribution = 165 M

Generation machine = 35 M

Total generation/min= 200 M

HEPA FILTER

Class 10,000

Minimum efficiency = 99.99%

99.97 % in following :

- room vacated after 3 hr. of use

(say for lunch)

- air changes increased