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CSQE Certified Software Quality Engineer Certification (CSQE)

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CSQE exam Dumps Source : Certified Software Quality Engineer Certification (CSQE)

Test Code : CSQE
Test Name : Certified Software Quality Engineer Certification (CSQE)
Vendor Name : Quality-Assurance
: 89 Real Questions

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Quality-Assurance Certified Software Quality Engineer

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Some look at various/nice Assurance (QA) Engineers work with desktop science-related applications. lots of what they do comprises making certain that application does what it be purported to do. On a daily foundation, they create test plans and check circumstances to investigate whether definite components of the program function as written. When issues arise, they're chargeable for finding and debugging tough spots in the code. QA utility Engineers also evaluation user interfaces to make sure performance and uniform design. they are present for every step of the utility building method, interpreting and reporting testing effects to their superiors and the rest of the software team.

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when it comes to character, they are methodical, organized, and detail-oriented. client delight is important to them, and they are dedicated to producing software of the very best quality. they are quickly newcomers with the flexibility to address changes in tasks, and that they don't seem to be frightened of group collaboration or individual work. it's a quick-paced position, and successful QA software Engineers are efficient people who've a "examine it to wreck it" angle. it's a really analytical and investigative class of labor, and enthusiasts of experimental strategies will thrive during this career path.

The actual necessities of being a application check engineer hardly ever go beyond finger dexterity the capacity to address prolonged sitting. Positions in this line of work are fully indoors and generally full-time. Most positions require a minimum of a bachelor's degree in computer science, software engineering, or related fields with just a few years of undertaking checking out leadership adventure. distinctive positions will require potential of different programming languages, however typical ones include C or C++ and JAVA. (Copyright 2019

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VARGO® crew member promoted to steer nice assurance engineer | Real Questions and Pass4sure dumps

Press releases are provided by companies as is and have not been edited or checked for accuracy. Any queries should be directed to the company issuing the liberate.

business Pressroom November 20, 2018

VARGO®, a number one issuer of fabric-coping with techniques integration, warehouse execution software and gadget solutions for predominant achievement and distribution centers, has promoted Abid al-Ikashi to lead exceptional assurance engineer.

HILLIARD, Ohio (November 20, 2018) — VARGO®, a leading provider of fabric-managing methods integration, warehouse execution application and machine options for important success and distribution centers, has promoted Abid al-Ikashi to guide first-rate assurance engineer.

Al-Ikashi will plan, coordinate and function first-class assurance processes for brand spanking new points, enhancements, malicious program fixes and installations for all VARGO® options. he will develop trying out tools and procedures, lead client support and installations, and also give onsite assist to VARGO® valued clientele.

"Abid has proven himself as a beneficial and hardworking worker during his time with VARGO®," mentioned Bart Cera, CFO and COO. "we are confident he'll continue to play a huge position in making certain VARGO® customers are receiving the best quality provider and help."

Al-Ikashi joined VARGO® in 2017 as a software engineer and worked as an onsite assist technician, focusing on high-quality assurance and product testing. in advance of that, he labored as an application developer at a Grove metropolis business and as an IT supervisor and programmer at a company in Baghdad, Iraq.

Al-Ikashi grew up in Baghdad, Iraq, the place he graduated from Al Mansour institution faculty with a Bachelor of Science in application engineering. Al-Ikashi also holds the Cisco licensed network association (CCNA) levels on and two Industrial certifications from Cisco. he is a member of valuable Ohio GameDev neighborhood for aspiring video online game builders, and he is a lead online game developer for Wild Beard video games, LLC, an impartial game construction enterprise.

Al-Ikashi lives in Westerville, Ohio (ZIP Code 43081).

observe Fusion EHR Achieves best Assurance (NCQA) Certification | Real Questions and Pass4sure dumps

Practice Fusion EHR

practice Fusion, the web-based mostly EHR enterprise, has performed affected person-based clinical home (PCMH) pre-validation from the country wide Committee for fine Assurance (NCQA) for NCQA’s PCMH 2017 software. This status brings follow Fusion’s customers one step closer to reaching PCMH cognizance in the course of the streamlined identification of capabilities fitness IT solutions. Practices that are able to obtain PCMH awareness reap a couple of measurable advantages as well as maintaining and enhancing upon the standard goal of presenting improved satisfactory look after sufferers. 

observe Fusion’s adherence to the PCMH mannequin of healthcare birth makes it less demanding for practices to meet the rigorous necessities required for medical home cognizance whereas perpetually building upon the principal theme of enhancing patient-concentrated care. As they flow into the new 12 months, a good affected person journey is fitting an ever-increasing precedence for the healthcare industry, and apply Fusion’s pre-validation popularity calls upon small practices to movement towards improving patient experiences by means of moving towards price-primarily based care.

apart from assisting supply normal stronger fine of look after patients, practices that achieve NCQA PCMH attention may also advantage in distinct techniques, together with:

– better effectivity and decrease apply charges. NCQA’s PCMH guidelines are highest quality-in-type for helping to streamline care coordination and care management.

– improved reimbursement support. Federal, state and industrial payers may also present incentive courses and more advantageous help to practices that get hold of NCQA PCMH cognizance.

– further attention. Accreditation indicates to patients that a tradition offers greater features and higher pleasant of care.

“by using offering application that helps general practitioner practices construct the patient-focused, coordinated care infrastructure expected of NCQA affected person-founded scientific buildings, follow Fusion is helping practices be part of modern healthcare’s most crucial transformations,” observed NCQA President Margaret E. O’Kane. “scientific homes are the way of the long run, and apply Fusion is helping practices get there.”

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Certified Software Quality Engineer Certification (CSQE)

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Career Choices: CSQA versus CSQE | real questions and Pass4sure dumps

Difference between Certified Software Quality Analyst- CSQA and CSQE-Certified Software Quality Engineer     I hope this will help Bangladeshi SQA Professionals, I already talked to QAI for opening a chapter like PMI Chapter in Bangladesh and will update you soon.   Many companies are requiring certification for hiring or advancement. There have been over 30,000  IT professionals that have sought CSQA certifications from Australia,Barbados, Belgium, Bermuda, Brazil, Canada, China, Egypt, Hong Kong,India, Israel, Korea, Mexico, New Zealand, Puerto Rico, Saudi Arabia,Singapore, South Africa, United Kingdom, United Arab Emirates, and the United States. 

Prometric is available at the following address for CSQA and PMP exam.Test Center InformationSite Code/Site Name: 8815 – DHAKA, BANGLADESH #8815

Site Address: AMERICAN ALUMNI ASSOCIATIONHOUSE 145, STREET 13B, BANANIDHAKA, 00 1213 BGDSite Phone #: 88029881669

Thanks to Shahrier for your interest in this CSQA Exam, it may not have any value in Bangladesh but in outside world do some research, company like TCS, Infosys, Wipro all CMMI Level 5 in India, they all have CSQA. QAI worked for most Indian CMMI assessment also same QAI is working now to assess CMMI level 3 Bangladeshi Companies, because I worked with QAI for Bangladesh IT companies CMMI assessment initiative and I know the Facts. So far Bangladesh only have one CMMI Level 3 company. It’s a shame for us, when they are planning to get IT Outsourcing work, they need more companies with CMMI at least Level 3 and more skilled IT Professionals.

Reference Link

Best Regrads

Sayeed Rahman


CSQE has more prerequisites compared to CSQA.

You must have eight years of on-the-job experience in one or more of the areas of the Certified Software Quality Engineer Body of Knowledge. A minimum of three years of this experience must be in a decision-making position (may or may not include management or supervisory positions). If you have completed a degree from a college, university, or technical school with accreditation accepted by ASQ, part of the eight-year experience requirement will be waived. You must also pass 1 exam ($360). Exam is a 160-question, four-hour exam offered twice a year. Members save $150 off the test. Membership costs $80 annually. You must also agree to comply with the ASQ code of ethics

 CSQA is more popular and recognized

If you want more info on CSQE check this link

 Certified Software Quality Engineer

CSQE Exam Preparation   Software Quality Engineer Certification

Body of Knowledge (NEW – Effective for the exam December 6, 2008)

http://www.testingeducation .org/course_notes/hoffman_doug/certified_software_quality_engineer_examination/csqe2002c.pdf

 Salary Survey Report for Certification ASQ-CSQE

 Certified Software Quality Analyst (CSQA)

QAI Membership

 The following is an outline of the topics that constitute the Body of Knowledge for Software Quality Engineering.

CSQA Vs CSTE which is better?

According to QAI

"Acquiring the designation of Certified Software Quality Analyst (CSQA) indicates a professional level of competence in the principles and practices of quality assurance in the IT profession. CSQA certification is a highly respected attestation of skills in this critical area of information technology."

"The Certified Software Test Engineer (CSTE) Program is intended to establish standards for initial qualification and provide direction for the testing function through an aggressive educational program."

CSQE Certification Requirements

Education and/or Experience

You must have eight years of on-the-job experience in one or more of the areas of the Certified Software Quality Engineer Body of Knowledge. A minimum of three years of this experience must be in a decision-making position. "Decision-making" is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.

If you are now or were previously certified by ASQ as a Quality Engineer, Quality Auditor, Reliability Engineer, or Quality Manager, experience used to qualify for certification in these fields applies to certification as a Software Quality Engineer.

If you have completed a degree* from a college, university, or technical school with accreditation accepted by ASQ, part of the eight-year experience requirement will be waived, as follows (only one of these waivers may be claimed):

  • Diploma from a technical or trade school-one year will be waived
  • Associate degree-two years waived
  • Bachelor’s degree-four years waived
  • Master’s or doctorate-five years waived
  • *Degrees/diplomas from foreign educational institutions must be equivalent to degrees from U.S. educational institutions.

    Proof of Professionalism

    Proof of professionalism may be demonstrated in one of three ways:

  • Membership in ASQ, a foreign affiliate society of ASQ, or another society that is a member of the American Association of Engineering Societies or the Accreditation Board for Engineering and Technology
  • Registration as a Professional Engineer
  • The signatures of two persons-ASQ members, members of a foreign affiliate society, or members of another recognized professional society-verifying that you are a qualified practitioner of the quality sciences
  • Examination

    Each certification candidate is required to pass a written examination that consists of multiple choice questions that measure comprehension of the Body of Knowledge. The Software Quality Engineer examination is a one-part, 160-question, four-hour exam and is offered in the English language only.

    Sample examination questions are included in the Study Guide .

    Examinations are conducted twice a year, in early March and mid-October, by local ASQ sections and foreign international organizations. All examinations are open-book. Each participant must bring his or her own reference materials. Use of reference materials and calculators is explained in the seating letter provided to applicants.

    Please Note: The Body of Knowledge for certification is affected by new technologies, policies, and the changing dynamics of manufacturing and service industries. Changed versions of the examination based on the current Body of Knowledge are used at each offering.

    Minimum Expectations for a Certified Software Quality Engineer

  • Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards, organizational and team dynamics, interpersonal relationships, and professional ethics.
  • Must possess an understanding of software quality management principles and demonstrate a comprehensive knowledge of developing and implementing software quality programs, to include tracking, analyzing, reporting, problem resolution, and training.
  • Must understand and be able to implement software development and maintenance processes and methods, to quantify the fundamental problems and risks associated with implementing software development support processes, and to assess, support, and implement process and technology changes.
  • Must possess a basic understanding of project management principles and techniques as they relate to software project planning, implementation, and tracking.
  • Must know how to select, define, and apply software measurement, metrics, and analytical techniques. Possess a basic understanding of measurement theory, techniques, and how to communicate results.
  • Must have a thorough understanding of software inspection, testing, verification, and validation. This includes knowledge of software and software work product early defect detection and removal, testing (e.g., types, levels, strategies, tools, and documentation) and verification and validation methods and techniques.
  • Must have a basic understanding of how and when to perform software audits including audit planning, approaches, types, analyses, reporting results, and follow-up.
  • Must possess a basic understanding of the configuration management process to include planning, configuration identification, configuration control, change management, status accounting, and reporting.
  • ======================

    From "Shahrier" 

    Benefits of becoming a CSQA  


    (Source CSQA CBOK)

    The CSQA program was developed to provide value to the profession, the individual, the employer, and co-workers. The following information is data collected from CSQAs in the IT industry – a real testimonial to the benefits and reasons to make the effort to become a CSQA.


    Value Provided to the Profession

    Software quality assurance is often viewed as a software project task, even though many individuals are full-time quality assurance professionals. The CSQA program was designed to recognize software quality assurance professionals by providing:

    §         Common Body of Knowledge (CBOK)

    The Certification Board defines the skills upon which the software quality assurance certification is based. The current CBOK has 10 skill categories.

    §         Examination Process to Evaluate Competency

    The successful candidate must pass a four-part examination that is based on the CBOK. You must receive a grade of 75%, or greater on each part. Only 31% of the pre-qualified applicants pass the examination the first time, making this a prestigious certification to obtain.

    §         Code of Ethics

    The successful candidate must agree to abide by a professional Code of Ethics as specified by the Certification Board.

    Value Provided to the Individual

    The individual obtaining the CSQA certification receives the following values:

    §         Recognition by Peers of Personal Desire to Improve

    Approximately, eighty percent (80%) of all CSQAs stated that a personal desire for self improvement and peer recognition was the main reason for obtaining the CSQA certification. Fifteen percent (15%) were required by their employer to sit for the examination, and 10% were preparing themselves for an improved quality-related position.

    §         Increased Confidence in Personal Capabilities

    Eighty-five percent (85%) of the CSQAs stated that passing the examination increased their confidence to perform their job more effectively

    §         Recognition by IT Management for Professional Achievement

    Most CSQAs stated that their management greatly respects those who put forth the personal effort needed for self-improvement. IT organizations recognize and reward individuals in the following ways:

    Within the first 18 months after receipt of the CSQA certification, of the successful candidates:

    Value Provided to the Employer

    With the need for increased software quality and reliability, employing CSQAs provides value in these ways:

    §         Increased Confidence by IT Users and Customers

    IT users and customers expressed confidence in IT to effectively build or acquire software when certified quality assurance practitioners were involved.

    §         Improved Processes to Build/Acquire/Maintain, Operate and Measure Software

    CSQAs use their knowledge and skills to continuously improve the IT work processes.

    CSQAs know what to measure, how to measure it, and then prepare an analysis to aid in the decision-making process.

    §         Independent Assessment of Quality Assurance Competencies

    The CSQA program is directed by a Certification Board of independent quality assurance experts. Through examination and recertification, they provide an independent assessment of the CSQA’s quality assurance competencies, based on a continuously strengthening Common Body of Knowledge for quality assurance practitioners.

    §         Quality Assurance Competencies Maintained Through Recertification

    Yesterday’s quality assurance competencies are inadequate for today’s challenges. CSQA recertification is a process that helps assure the CSQA’s skills remain current. The recertification process requires CSQAs to obtain 40 hours of quality assurance related training per year in topics specified by the Certification Board.

    From an IT director’s perspective, this is employee-initiated quality assurance training. Most, if not all CSQAs, do this training during their personal time. IT organizations gain three benefits from CSQA recertification: 1) employees initiate improvement; 2) quality assurance practitioners obtain competencies in quality assurance methods and techniques; and 3) employees train during personal time.

    Value Provided to Co-Workers

    The drive for self-improvement is a special trait that manifests itself in providing these values to co-workers:

    §         Mentoring the Testing Staff

    Forty-five percent (45%) of the CSQAs mentor their testing colleagues by conducting training classes; encouraging staff to become certified; and acting as a resource to the staff on sources of IT quality related information.

    §         Testing Resource to "IT" Staff

    CSQAs are recognized as experts in quality assurance and are used heavily for advice, counseling, and for recommendations on software construction and testing.

    §         Role Model for Quality Assurance Practitioners

    CSQAs are the IT role models for individuals with quality responsibilities to become more effective in performing their job responsibilities.

    QAI, as CSQA program administrators, will assist you in this effort.

    See  for detailed information.


    B. M. Shahrier Majumder 

    My Blog:


    Certified Software Quality Analyst (CSQA)

    Dear All,

    CSQA (Certified Software Quality Analyst) Certification is recognizedworldwide as the standard for software quality assuranceprofessionals. Certification is a big step; a big decision.Certification identifies an individual as a quality assurance leaderand earns the candidate the respect of colleagues and managers. It isformal acknowledgement that the IT recipient has an overallunderstanding of the disciplines and skills represented in acomprehensive Common Body of Knowledge (CBOK) for a respectivesoftware discipline.

    CSQA designation is quickly becoming the standard for IT softwarequality professionals around the world. Many companies are requiringcertification for hiring or advancement. There have been over 30,000IT professionals that have sought CSQA certifications from Australia,Barbados, Belgium, Bermuda, Brazil, Canada, China, Egypt, Hong Kong,India, Israel, Korea, Mexico, New Zealand, Puerto Rico, Saudi Arabia,Singapore, South Africa, United Kingdom, United Arab Emirates, andthe United States.

    The CSQA certification examination is based upon the skill categoriesidentified in the CSQA CBOK Outline. As such, this guide to the CBOKwas designed for you to use as material in preparation for the CSQAexam. The examination presumes that you have had broad exposure toquality practices. It is expected that you have reviewed and readcurrent literature available on software quality and testing.

    The CSQA program demonstrates the following objectives to establishstandards for initial qualification and continuing improvement ofprofessional competence. This certification program helps to:

    1. Define the tasks (skill categories) associated with softwarequality assurance duties in order to evaluate skill mastery.2. Demonstrate an individual’s willingness to improve professionally.3. Acknowledge attainment of an acceptable standard of professionalcompetency.4. Aid organizations in selecting and promoting qualified individuals.5. Motivate personnel having software quality assuranceresponsibilities to maintain their professional competency.6. Assist individuals in improving and enhancing their organization’ssoftware quality programs (i.e., provide a mechanism to lead aprofessional).

    (Source: CSQA CBOK)

    From this year this exam is Prometric based, so they can sit for theexam in BD. The exam fee is $ 350. You will find the detailinformation about CSQA from

    I am interested to sit in this exam. If any body interested for CSQAthen let me know then they can take the preparation together. I havedone the plan for CSQA exam preparation; it will take around 3 months.

    VectorCAST Certified for Medical Software Engineering | real questions and Pass4sure dumps

    December 04, 2018 10:00 ET | Source: Vector Software


    TÜV SÜD Certificate

    TÜV SÜD Certificate Image rights: TÜV SÜD Rail GmbH

    TÜV SÜD Rail GmbH

    PROVIDENCE, R.I., Dec. 04, 2018 (GLOBE NEWSWIRE) -- VectorCAST, Vector's test automation platform, has been certified according to IEC 62304:2015 for medical software engineering. TÜV SÜD confirms that the development was performed in accordance with the life cycle processes for medical device software. 

    Vector, the leading manufacturer of software tools and embedded components for the development of electronic systems, announced that its test automation platform VectorCAST has been recertified by TÜV SÜD. As part of the recertification of IEC 61508, EN 50128 and ISO 26262, the TÜV SÜD certificate was extended to include the international standard IEC 62304 for the development of software for medical devices.

    The VectorCAST product family automates testing activities throughout the software development life cycle. VectorCAST supports automated test execution for unit and integration testing, code coverage analysis and test project management.

    "We are pleased that VectorCAST is now a TÜV SÜD-certified product for medical device software development," said Jeffrey Fortin, Product Manager at VectorCAST. "This certification confirms the quality and reliability of their product.”

    More information at:

    You can find this and other press releases on their website at:

    Vector is also active in popular social networks:

    Your local press contact:Anna BarcelosTel. +1 401 398 7185Fax +1 401 398 7186E-Mail: Vector Software, Inc.1351 South County Trail, Suite 310East Greenwich, RI  

    Vector press contacts worldwide you will find at:

    About the Vector Group:Vector Informatik is the leading manufacturer of software tools and embedded components for the development of electronic systems and their networking with many different systems from CAN to Automotive Ethernet.

    Vector has been a partner of automotive manufacturers and suppliers and related industries since 1988. Vector tools and services provide engineers with the decisive advantage to make a challenging and highly complex subject area as simple and manageable as possible. Vector employees work on electronic innovations for the automotive industry every day. Worldwide customers in the automotive, commercial vehicles, aerospace, transportation, and control technology industries rely on the solutions and products of the independent Vector Group for the development of technologies for future mobility.

    Vector worldwide currently employs more than 2,000 people with sales of EUR 518 million in 2017. With its headquarter in Germany (Stuttgart), Vector has subsidiaries in the USA, Japan, France, Great Britain, Italy, Austria, Sweden, South Korea, India, China, and Brazil.

    A photo accompanying this announcement is available at


    East Greenwich, Rhode Island, UNITED STATES


    TÜV SÜD Certificate Image rights: TÜV SÜD Rail GmbH

    TÜV SÜD Rail GmbH

    Formats available:


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    Implementing Training Programs for Software Quality Assurance Engineers | real questions and Pass4sure dumps

    Medical Device & Diagnostic IndustryMagazineMDDI Article Index

    An MD&DI October 1998 Column


    Given their potential to reduce software failures, well-trained SQAEs are essential for devices that rely on software.

    Software quality assurance engineers (SQAEs) play a key role in ensuring the safety and efficacy of device software and ultimately the devices themselves. As FDA begins to examine the software design process and quality system software more closely, the need for well-trained SQAEs becomes critical for product quality. A necessary but often overlooked aspect of producing well-trained SQAEs is the implementation of a training program to guarantee adequate and consistent development methods and design controls for product and quality system software. Training can also benefit new SQAE hires who may not have significant experience in the medical device industry or who may not understand the company's established development methods and relevant quality system requirements. This article focuses on some of the key elements necessary in implementing a successful software quality assurance training program.


    Most successful trainers exhibit common traits, such as mastery of and enthusiasm for their subject, patience, flexibility, and a willingness to explain their rationale for decisions. In some ways, successful trainers serve as mentors for new hires in that they help guide the direction a new hire takes in the company. The most important aspect of selecting a technical trainer is choosing someone who wants to train a new hire and whose personality is compatible with the particular trainee. Trainers may have undergone a similar training program earlier in their own careers, or they may have been certified as an SQAE trainer by their company through a train-the-trainer initiative. In some companies, the trainer may simply be the most experienced individual in the company. To be successful, a training program needs both genuinely interested trainers and support from corporate management.

    Figure 1. Decision tree for assessing training needs.

    To meet training goals and use time efficiently, it is important for the trainer to assess the individual's training needs. The trainer must determine whether the trainee is new to software quality assurance, new to the medical device industry, or new to a particular area of the medical device industry (e.g., pacemaker manufacturing). Regardless of the SQA-related experience level, training must be provided on the company's procedures for design controls, document controls, and other key aspects of the quality system. Figure 1 represents a decision tree for assessing the training needs of an individual.


    A senior SQAE trainer should be assigned to each new SQAE trainee. This trainer should not only execute assigned portions of the formal training plan, but also support the new SQAE for at least six months. The training program should consist of an overall syllabus (i.e., body of knowledge), with a training plan created for each individual. This involves tailoring the syllabus to each trainee's needs and prioritizing the skills training based on the individual's experience and target assignments. If one-on-one training is not an option, the alternative would be to group new hires under a general training plan with one trainer for the group. This approach is less desirable because trainees do not receive as much individual attention, and the plan is not tailored to each person's specific needs. Instead of training when each individual is hired, the company waits until it has enough employees to form a training group. This could result in potential negative corporate impacts based on work performed by new hires as they wait for other employees to join the company so that a training group can be formed.

    The training plan should begin within the first two weeks of the trainee's employment and span at least eight weeks. Individuals who lack software quality assurance experience and medical device industry exposure may require more than eight weeks. For those companies that can't afford to make this commitment, other options include requiring more experience of SQAE hires, using alternative training media (e.g., computer-based training, videotapes), relying on new hires to self-train in their off-hours, or outsourcing the software quality assurance tasks.

    These options, however, are less desirable and pose greater risks to the company because they lead to inconsistent software development approaches. Without an adequate training program, manufactured devices may not meet specified requirements or may carry a high number of latent defects. Furthermore, compliance with established design control procedures may not be apparent or may be lacking entirely. In companies that tend to cut corners by failing to implement a training program, a development team may look for the answer to each query by approaching every member of the SQAE team independently, rephrasing the same question in the hopes of finding an easy answer.

    The individualized training plan combines reading, lectures, and hands-on execution of tasks in the following phases:

  • Assigned trainer gives lectures, combined with hands-on examples/exercises. New employee orientation, such as safety program training and quality manual training, also takes place.
  • Assisted hands-on execution of tasks (shadowing trainer) with the goal of significant exposure to the job.
  • Trainer and manager assess trainee's readiness to work alone on individual tasks and assignments.
  • New SQAE works alone with question and answer follow-up sessions held with trainer. The trainer reviews each assignment before it is considered complete. The goal of this phase is to begin introducing the trainee into the company's workflow.
  • Trainer and manager decide whether or not the employee will begin working independently. This phase consists of assessing the trainee's progress in the SQAE domain and determining whether or not the training plan has succeeded.
  • New SQAE works alone. At this point, the intensive training is complete, and the trainee is an independent SQAE. On-going assessment of the SQAE's effectiveness becomes part of the com- pany's standard performance appraisal process.

    The following sample training plan is designed for trainees who are new to the company and the medical device industry and have a minimum of two years' experience as SQAEs. These sessions complement lectures and assisted hands-on execution of tasks.

    SESSION 1: SQAE Introduction

  • Introduction to SQA personnel and management and discussion of QA organization chart.
  • Description of overall company function, products, and types of software.
  • Overview of company software development process and standards.
  • Overview of company software quality process and standards.
  • Overview of typical software development deliverables and software quality deliverables.
  • SESSION 2: SQA Interfaces

  • History of SQA at the company.
  • Relationship and level of involvement of SQA with different software groups.
  • Indication of software groups new SQAE will work with.
  • Organization chart, indicating the key software contributors and their roles and relationships, etc.
  • SESSION 3: Relevant Corporate Standards

  • Train on industry standardsand application of these standards to the company.
  • Train on certification-based standards, if appropriate.
  • SESSION 4: Design Controls

  • Address company requirements for product development and maintenance, with specific focus on software.
  • Step through the product development process.
  • Step through the software development process.
  • SESSION 5: Configuration Management (CM)

  • Address company requirements for configuration management, with specific focus on software.
  • Step through the product configuration process.
  • Step through the software configuration process.
  • Demonstrate the system by selecting one or more software documents/specifications from the repository and pointing out the control mechanisms. Do the same with one or more software releases.
  • SESSION 6: Software-Related Standard Operating Procedures

  • Step through specific software development, software quality, and software CM procedures and practices, explaining how each implements and complies with the higher-level policies and standards.
  • Step through the sample planning documents, indicating how each implements the company standards and procedures.
  • SESSION 7: Assisted Hands-On Task Review

  • Using the audit checklists created in the homework assignment for session 6, execute an informal audit of one or more software development areas and the CM function for those areas. Discuss findings.

    Time is the single most important issue facing the SQAE manager who decides to implement a training program. Since the most effective SQAE trainers are typically the senior SQAEs, the company usually desires close to 100% of their time to be spent on key development projects. For the training plan to succeed, expectations for the trainer's project support time must be scaled back until the assigned trainee has graduated.


    To ensure that the training plan is working, periodic review of the trainee's progress is helpful. This can be provided by a senior SQAE, the SQAE manager, or a knowledgeable, unbiased third party. The goal of the progress review is to identify any weak areas and ascertain whether the trainee has successfully completed the topics assigned by the trainer. If new areas of concern are noted during the progress review, the manager and trainer should modify the training plan to address these concerns. Ideally, this review coincides with a probationary performance review, if required by the company. Also, the employee's progress, including completion of the training plan, should be documented for the personnel record.


    A competent SQAE team serves both corporate and individual objectives. The development of safer, more-effective devices benefits the company; meanwhile individuals become more valuable to the industry, resulting in their increased recognition and compensation. The short-term goal for any new SQAE should be to establish expertise by completing the training plan.

    The easiest way to demonstrate competency is to pursue professional certification. At present, one of the most widely recognized certifications for SQAEs is the American Society for Quality's certification in software quality engineering (CSQE). (For further information, contact the American Society for Quality at 800/248-1946.) The CSQE, or a similar certification program, should become a goal for each member of the SQAE team. A new SQAE's long-term goals should include achieving a level of competency that leads to a role as a process improvement advocate, a trainer for a new SQAE, or both.


    The following homework assignments correspond to the lecture sessions described in the sample training plan (above).

    SESSION 1: Read company software development and software quality policy/standards.

    SESSION 2: If company is certified (or pursuing certification) to any industry standards, such as ISO 9001, and if the new employee is unfamiliar with these standards, the trainee should read them thoroughly before the next session. Otherwise, the trainee should reread the company software development and quality policies/standards and document any questions. The trainee should also read the GMPs and relevant reviewer guidance.

    SESSION 3: No homework.

    SESSION 4: Read company standards and high-level procedures for configuration management.

    SESSION 5: Read detailed software development and quality procedures, practices, etc. Also read a sample project plan, software development plan, software quality plan, and software CM plan (preferably from one of the projects/departments to be supported by this new SQAE).

    SESSION 6: Create sample audit checklists against one software development procedure and one software CM procedure.

    SESSION 7: No homework.


    In the past three years, two device companies have adopted a training plan similar to the one described here and achieved excellent results. Initially, the time investment seemed overwhelming; however, the performance level of trained individuals who completed their training plan has been outstanding. Furthermore, the consistency in overall SQAE methodology throughout these organizations improved significantly after implementing the training program.

    Trainers and trainees who completed the training plan gained significant benefits. The trainers gained satisfaction in watching the development of their assigned trainees and developed a good working relationship with them. Trainees were quickly made to feel a part of the team and established a base on which to make future decisions concerning device software.

    The successful outcome of implementing a formalized SQAE training program has more than paid for the initial investment made by the two domestic device manufacturers referred to above. The lessons learned in implementing this approach follow:

  • Training progresses at a different rate for each individual. Overall experience, industry experience, formal education, device knowledge, and enthusiasm all play a role in determining the right amount of time to dedicate to any specific topic.
  • Not every good SQAE is a good trainer. Serving as a trainer requires a solid command of the subject, interest in training, and infinite patience.
  • The SQAE manager needs to monitor the relationship between the trainer and trainee; strong personality conflicts or insufficient interest/patience on the part of the trainer is counterproductive. The manager should be prepared to intervene and assign a new trainer if necessary.
  • Upon completion of each individual's training program, the sponsoring department should consider marking the event as a cause for celebration. Acknowledging the trainer's efforts is critical in keeping trainers motivated.

    Specific technical training on the company's medical device(s) should be conducted concurrently with the general SQA lectures.

    SESSION 1: Current Device Introduction

  • Introduction to device(s) currently in production.
  • Tour of manufacturing facility (if colocated with R&D).
  • SESSION 2: Device Retrospective Review

  • Introduction to device(s) no longer in production but still in active use by the user community.
  • SESSION 3: Introduction to Device Technology

  • Review of device design for a given current product.
  • SESSION 4: Current Device Software Review (Part I)

  • Review of software design and code for product introduced in Session 3.
  • SESSION 5: Current Device Software Review (Part II)

  • Review of software design, code, and test protocols for another device (i.e., other than the Session 3-4 device).
  • SESSION 6: Support Software Review

  • Review of software design, code, and test protocols for selected production control or quality system support software.

    Establishing a formal SQAE training program benefits both the company and the individual. A thorough body of knowledge is established for the SQAEs, and a process for attaining that body of knowledge is defined. In addition, a training program establishes consistent SQA methods throughout the company, which reduces overall corporate risks during product development. By implementing a training program, the company increases each SQAE's value, resulting in safer, more-effective devices.

    A well-structured training program can provide a solid first step toward employees attaining certification. Professional certification efficiently answers third- party auditors' questions about SQAEs adequate job knowledge and moves the auditor on to other topics. Thus, if certified professionals cannot be found during the hiring process, the company should encourage new employees and support their efforts to attain certification.

    The onset of regulated design controls necessitates a strong device development methodology. Software quality assurance plays a key role for every device that relies on software control, as well as for those quality system elements that rely on software. Without a solid training program, software quality assurance engineers may not be adequately equipped to implement effective medical device software design controls.

    Tammy M. Pelnik is vice president of The St. Vrain Group, Inc. (Boulder, CO), and a certified quality manager. Gayla J. Suddarth is a quality manager with Tanning Technology Corp. (Denver) and a certified software quality engineer.

    Copyright ©1998 Medical Device & Diagnostic Industry

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