Kim, Line and Genki

Standard tests are conducted at room temperature with no acceleration of any parameters.

There are several types of tests such as cycle testing, typical use testing, and 10 x 10 testing.

Cycle testing is conducting tests on individual components.

Or it could consist of passing the state of operation and non-operation of a component or device.

An example being a power supply could be cycled on for 8 hours and off for 16 hours.

Typical use testing is testing the device as it will be operated in its typical environment.

This testing can help show reliability. It can also be used to calculate a long term

mean time between failures value.

10 x 10 testing: There are ten samples that tested for a particular parameter at ten different times.

The mean and standard deviation values are then calculated for each of the ten recordings and ten units.

The horizontal rows of data show the repeatability of the results. The vertical columns of data show the variability among the units measured.

10 x 10 testing

Evidence needs to be collected to demonstrate that the process and products have met specifications.

Software verification is performed during product development to make sure that the development process, methodology and design have been met.

Software validation is the end activity to development and demonstrates that the software satisfies its goals.

Requirements: • Regulatory Agencies• International Communities• Corporate Commitments

A good software quality assurance program• Minimize redundancy• Assure access to information• Integrate information

Software designers should:• Perform their design activates• Store the resultant design• Generate tests that specify the testing to be

conducted to validate the design

The tests should target:• Integrated software components• Interfaces between the integrated

tasks/functions • Path testing between various tasks/functions.

Verification • Quality Control process (match specification?)• Requires a stable and defined life cycle

Validation• Quality assurance process (customer want?)• Requires that verification is working

“cradle to grave” development of the software (The conception of the project to its termination)

Efficient verification and validation organization

• Producing salient results during the validation effort• Permeating a common test approach.

1. Survey of each product line and test equipment

2. Static and dynamic testing tools• Static: Symbolic approach• Dynamic: Test the software system with ‘live’ data

Medical companies -Validation

• Products• Test/manufacturing equipment.

Phases of Software Development

• Code and Test – development of the code and debugging the implemented code by the software developers.

• Integrate and Test –integration of the software components and the testing of the integrated parts.

• Software system testing - verification and validation testing that is performed by the engineers on the fully integrated software and hardware.

Categorization of the life cycle of the product/equipment.

Full software development life cycle – ◦ Is applied when new products = high level of concern. YouTube - Software Development Life Cycle [SDLC]

Accelerated enhancement development life cycle –◦ If the product is based on existing products then majority

of the faults are already taken care of.

Requirements testing – ◦ Consists of development efforts that include a production

of requirements design specifications.

Safety testing – ◦ Validation in the focus consists of preventing harm to the

user. hazard analysis – i.e. medical products surveying of the environment

This level of testing is the responsibility of

the software engineers who develop the code.

Test documentation ◦ Life Cycle◦ Level of concern

The verification and validation report summarizes the results of verification and validation activity.

The summary contains: ◦ Description of tasks performed◦ Number of cycles◦ Summary of task results◦ Summary of errors and their resolutions

Description and location Impact Criticality Rational for resolution Results of re-test

◦ Assessment of the software reliability

Edward Kit is founder and president of Software Development Technologies (SDT).

He is well known as an industry leader, test expert, author, and keynote speaker at testing conferences.

His best-selling book, Software Testing in the Real World: Improving the Process, has been adopted as a standard by companies around the world such as Sun Microsystems, Exxon, Chase Manhattan Bank and Cadence Design Systems.

1. The quality of the test process determines the success of the test effort.

2. Prevent defect migration by using early life-cycle testing techniques.

3. The time for software tools is NOW!4. A real person must take responsibility for

improving the test process.5. Testing is a professional discipline requiring

trained, skilled people.6. Cultivate a positive team attitude of creative

destruction.

1. The quality of the test process determines the success of the test effort.

The test group should focus on improving its own internal process.

Immature test processes within an immature development organization will result in unproductive, chaotic, frustrating environments that produce low quality and unsatisfactory products.

2. Prevent defect migration by using early life-cycle testing techniques.

More than half the errors are usually created in the requirements phase. Errors can be minimized if they are found in the same phase as when they are introduced.

3. The time for software tools is NOW! There are a variety of tool vendors to

choose from with a variety of products. Having a strategy for tool acquisition and

a proper procedure for handling tool selection is important. This is an area where there may be a strong case for independent expert advice.

4. A real person must take responsibility for improving the test process.

The testing group could undergo distress, resulting in the request for improvements to a few key issues such as better specifications and better reviews.

Management should appoint someone to prioritize potential improvements and lead the testing improvement effort.

5. Testing is a professional discipline requiring trained and skilled people.

1. The software testing process has evolved considerably and now requires trained professionals.

2. Testing should be independent, unbiased, and organized for the fair sharing of recognition and rewards for contributions made to improve product quality.

6. Cultivate a positive team attitude of creative destruction.

There is a need to establish the proper “test to break” attitude that has a positive effect on testing success.

“test to break” attitude ◦ Objective is to show that the product does

what it shouldn’t do and doesn’t do what it should.

Drugs are created in one of three ways: › Trial and error› Computer modeling of the chemical structure› Acquiring/testing unusual fungi, viruses, and

molds. After a drug has made it past test tube

stages, tests are done on two relevant animal models. › Primarily rats, mice and other rodents are used.

The structure and function of the testing facility doing the research must follow government regulations for good laboratory practice. For example:◦ animal care and testing procedures, ◦ test and reporting procedures, ◦ requirement for quality assurance.

This helps assure that the laboratories are run properly and the results of the activities are correctly documented.

If a drug has been proven to be effective on animal models, the test of the drug may proceed to clinical trials if the FDA believes that the testing has shown potential value for the disease under study.

Before the testing process begins, a committee of medical and lay personnel study the proposed drug’s test and protocol.

Once the committee approves the drug for testing, phase 1 of clinical trials starts.

Phase 1 of a clinical trial involves 20-100 people, typically healthy volunteers or patients.

› This phase is designed to assess the drug for acute adverse effects and examine the size of doses that patients can take safely without a high incidence of side effects.

› Phase 1 lasts a few months

› ~70% of drugs pass this first test.

Phase 2 of a clinical trial tests several hundred patients to determine short term safety and effectiveness.

› Phase 2 takes months to years to perform

› ~ 50% of the drugs fail here.

Phase 3 tests the drug on several thousand patients where primary questions about drug safety, dosage, and effectiveness are being addressed.

› Large samples are usually performed in order

to obtain good statistics which will be used in the literature that accompanies the prescription.

› About 60-70% of drugs pass this phase.

After phase 3, the FDA is petitioned for a new drug approval.

› which takes an additional two years.

Phase 4 investigates the continued efficacy and long term effects of the drug in use.

Questions?