Group I

Quality Assurance
Members:
Noel Ara
May Marie Estrada
Cecille Caranto

What is Quality Assurance?

Systematic Process
Prevent quality problems from occurring
Processes and procedures that ensures
quality standards are being met

Quality Assurance standards

Name of QA standard

Issuing body

Applies to:

ISO 9001: Quality Systems

International Organization for
- Model for quality assurance etc.
standardization

General supplier qualification

Code of Good Manufacturing

Practice (GMP)

Pharmaceuticals and sterile

Australian Health Authorities

products

Testing Laboratory Certification

National Assoc. of Testing Qualification of testing
Standard
Laboratories (NATA)(Aust) laboratories
API Q1 Quality Program

Mil-Q-9858

American Petroleum Institute

industry
US Dept. of Defense

Forces

Suppliers to the US petroleum

Suppliers to the US Defense

Quality Assurance standards

ISO 9004-1: General quality guidelines to implement a quality system.

ISO 9004-4: Guidelines for implementing continuous quality improvement within the
organization, using tools and techniques based on data collection and analysis.
ISO 10005: Guidance on how to prepare quality plans for the control of specific
projects.
ISO 10011-1: Guidelines for auditing a quality system.
ISO 10011-2: Guidance on the qualification criteria for quality systems auditors.
ISO 10011-3: Guidelines for managing quality system audit programs.
ISO 10012: Guidelines on calibration systems and statistical controls to ensure that
measurements are made with the intended accuracy.
ISO 10013: Guidelines for developing quality manuals to meet specific needs.

The ISO 9000 series of QA standards

Source: http://www.iso.ch/

In addition, ISO 9001 requires organizations to include documented systems in their QA system to cover all
aspects of:
basic quality control (inspection, testing, test records, traceability, etc.)
a product's life cycle from the time negotiations start with the customer, through the design process, purchasing
of raw materials, production, storage, and final delivery

Dimensions of Quality
Performance - main characteristics of the
product/service
Aesthetics - appearance, feel, smell, taste
Special features - extra characteristics
Conformance - how well product/service
conforms to customers expectations
Safety - Risk of injury
Reliability - consistency of performance

Dimensions of Quality (Contd)

Durability - useful life of the
product/service

Perceived Quality - indirect evaluation of

quality (e.g. reputation)

Service after sale - handling of customer

complaints or checking on customer
satisfaction

The Costs of Poor

Quality

Prevention Costs
Appraisal Costs
Internal Failure Costs
External Failure Costs

Costs of quality assurance

Prevention Costs
QC administration and systems planning
Quality training
Quality planning (QC engineering work) Incoming, inprocess, final inspection
Special processes planning
Quality data analysis
Procurement planning
Vendor surveys
Reliability studies
Quality measurement and control equipment
Qualification of material

Costs of quality assurance

Appraisal Costs

Testing
Inspection
Quality audits
Incoming test and inspection and laboratory
acceptance
Checking labor
Laboratory or other measurement service
Setup for test and inspection
Test and inspection material
Outside endorsement
Maintenance and calibration
Product engineering review and shipping release
Field testing

Costs of quality assurance

Internal Failure Costs

Scrap, at full shop cost

Rework, at full shop cost
Scrap and rework , fault of vendor
Material procurement
Factory contact engineering
QC investigations (of failures)
Material review activity
Repair and troubleshooting

Costs of quality assurance

External Failure Costs

Complaints and loss of customer goodwill

Warranty costs
Field maintenance and product service
Returned material processing and repair
Replacement inventories
Strained distributor relations

When is QA appropriate?

How to implement a QA system?

How to Do QA Testing

Determine your goals and objectives

Define your customer
Pay attention to customer needs
Do not forget about costs
Test the product
Develop a workflow plan
Develop process controls
Continue to monitor

Phases of Quality Assurance

Inspection
before/after
production
Acceptance
sampling

The least
progressive

Inspection and
corrective
action during
production
Process
control

Quality built
into the
process
Continuous
improvement

The most
progressive

Inspection
How Much/How Often
Where/When
Centralized vs. On-site
Inputs

Acceptance
sampling

Transformation

Process
control

Outputs

Acceptance
sampling

Where to Inspect in the Process

Raw materials and purchased parts
Finished products
Before a costly operation
Before an irreversible process
Before a covering process

Importance of Quality
Assurance

Reputation and Image

Liability
Productivity
Costs

Continuation

Scrap Reduction
Time Efficiency
Increased Customer Satisfaction
Improved Employee Morale

Quality Assurance is not Quality

Control

Thank you