G2 Quality Assurance

QUALITY
ASSURANCE
Group 2
Narciso, Noralyn S.
Jupiter, Stephen
Casimiro, Jasper V.
Decretales, Kristian
Echanique, Stephanie
What is Quality
■ The ability to make the same thing the same way, over
and over again
■ Customer buys today is same as what they bought last
week or will buy next week
■ Product meets customer’s expectations 100% of the
time
Customer expectations
■ This is where quality programs begin.

– Marketing has defined the customer expectations.
– Product development has created a product that meets those
expectations.
– Engineering has designed a process to make the desired
product.
– Now, all QA must do is design a control system that verifies
that everything is working as designed.
Statistically based process
■ You cannot inspect quality in.
■ The process must be able to meet the specifications or there will be a lot
of rework.
■ Programs have to be statistically based.
■ There must be integration between R&D, engineering and marketing to
define a product that can be made 99% of the time.
■ The program that is designed to control the process must then make
sense.
Understand use of product
■ Retail population
■ Industrial customer
– Make sure that the customer knows what he wants
– Learn what process they are going to be using
– Monitor customer feedback — suggestions and complaints
– Develop product that the customer is looking for
What is Quality Assurance?
■ “Part of quality management focused on providing

confidence that quality requirements will be fulfilled“ – ISO
9000
■ A means of checking that a product or service is fit for
purpose by testing both the end product and also the
components that make up the product.
■ It's about raising everyone's expectations of what is excellent.
Why is it Important?
■ It saves your money and time.

■ Stable and Competitive Product.
■ Safety.
■ Reputation.
■ It helps meet clients’ demands and expectations.
■ New suggestions and views on your project
“It shows the difference between a poor, an average, and an excellent

company.”
What is GMP(Good manufacturing process)
■ GMP is part of Quality assurance which ensures that
the products are consistently manufactured and
controlled to the Quality standards.
■ GMP is a set of principles and procedures to help the

products manufactured will have the required quality.
Why it is Important?
■ Prevention of Mix-ups
■ Provide Traceability
■ Accountability of actions
■ Responsibility
■ Product Performance Guarantee
Factors Influencing Quality Assurance
■ EDUCATION
■ RECORD
■ LEADERSHIP
■ FACILITIES
■ AUTONOMY
Components of Quality Assurance
■ Monitoring and evaluating process and services.

■ Identifying , hiring and retaining the appropriate personnel.
■ Meeting rules and regulations.
■ Speaking to risk management issues.
■ Addressing and resolving any identified problem/issues.
The Process of Quality Assurance
Main Premises of Quality Improvement
■ Focus on organizational mission.

■ Continuous improvement.
■ Customer oriented.
■ Leadership commitment.
■ Empowerment.
■ Collaboration/crossing boundaries.
■ Focus on process.
■ Focus on data and statistical thinking.
Quality Assurance vs Quality Control
Quality Assurance Quality Control
■ A part of quality management focused on ■ A part of quality management focused

providing confidence that quality on fulfilling quality requirements.
requirements will be fulfilled.
■ The operational techniques and
■ Planned and systematic activities
implemented within the quality system activities used to fulfill requirements
provide confidence that a product or service for quality.
will fulfill requirements for quality. ■ Quality Control just measures and
■ Is a complete system to assure the quality of determines the quality level of products
products or services. or services. It is a process itself.
Functions of Quality Assurance
■ To maintain standards & specification for all raw material & finished product.
■ To give service to company in all areas related to product quality includes trouble
shooting, visiting, production, facilities, designing and training Quality control panel.
■ To produce information that is accurate, reliable and adequate for the intended purpose.
■ Evaluating performance, service, of the quality of a product against a system, standard
or specified requirement for customers
Installation of QA plan
■ Organization of department
– Make use of supervisors
■ Amount and quality of training affects finished product quality
– Every line employee should be trained
– Verify job is being done correctly
■ Automation of process changes types and quantities of analyses needed
– Speed of testing
– What level of accuracy is necessary
– Maintenance and calibration of lab equipment
– Training of technicians
– Verification of accuracy and variation of technicians
QA operation
■ Reviewing the daily lab and production reports is a part of the QA

responsibilities. This is to determine that the procedures are being
followed and the tests are being made. QA can spot trends by conducting
consistent record reviews. If record reviews don’t stay current, no one
will get timely feedback before a real problem crops up.
QA operation
■ If certain tests take several days to complete, the department must create a
record review, and a well-coordinated release procedure must be
developed so that product is not shipped prior to the completion of all the
tests.
■ Electronic, as well as actual, inventory-control procedures are necessary,
and fall under the supervision of QA.
■ This is where a great deal of pressure is brought to bear on the QA
function. The company has orders to fill and customers to keep happy, but
the test results are not available. As the industry develops new, rapid
procedures for microbiological testing, this time lag will decrease
dramatically.
QA operation
■ The question is easier to answer with food-safety issues
than with quality deviations.
– With food safety, if you don’t know or there is doubt, you don’t
ship anything.
– However, with quality deviations, the manager must ask how
bad the out-of-specification condition is.
■ Previous customer complaints about a problem can be reported along with the test
data.
■ One recommendation might entail a quality review committee established by upper
management that will make these decisions based on the data furnished by QA.
■ This should occur at a management level that understands the total ramifications of
a decision to ship or not ship the product. Usually, these are the people that
established and approved the original product specifications.
QA operation
■ Raw-material deviations are easier to deal with.
– Is the product safe to use? If the answer is no, then it is rejected.
– Can the company make a good, quality finished product from the
out-of-specification raw material?
■ If yes, then it is accepted and a deviation report is sent to the supplier.
– Can the supplier replace the raw material in time to maintain the
production schedule?
■ If not, then how badly does the company need the final product it contains?
■ If it is critical, then can manufacturing make a processing change to
accommodate the raw-material deviation?
■ If not, then it is still rejected.
– Purchasing and production must receive notification immediately

of all raw-material problems.
QA operation
■ Production and purchasing should get feedback regarding raw-
material and finished-product compliance, both the good, as well as
the bad.
■ These departments need advance notice of any negative trends that
have been detected before they become out-of-specification
problems.
■ Recommendations on how to improve the process are always
helpful, especially if someone has been observing the causes and
effects of the various process inputs on the final product.
QA operation
■ Only install new procedures that are based on verified cause-

and-effect analysis.
■ Companies must avoid overly restrictive specifications that are
not directly linked to product safety, government regulations or
product quality, since these only raise the cost of the operation.
QA operation
■ QA is the voice of the customer in the plant
■ Establish the expectation that the products that are to be
made will meet the specifications of the customer.
■ Go to the people on the line and explain what the
customer expects from the products.
■ Get out of the office and ask the people what is going on.
Thank you

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QUALITY

■ This is where quality programs begin.

■ “Part of quality management focused on providing

■ It saves your money and time.

“It shows the difference between a poor, an average, and an excellent

■ GMP is a set of principles and procedures to help the

■ Monitoring and evaluating process and services.

■ Focus on organizational mission.

Quality Assurance Quality Control

■ A part of quality management focused on ■ A part of quality management focused

■ Reviewing the daily lab and production reports is a part of the QA

– Purchasing and production must receive notification immediately

■ Only install new procedures that are based on verified cause-

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