1. S OFTWARE QUALITY INFRASTRUCTURE COMPONENTS

2. INFRASTRUCTURE COMPONENTS to prevent software errors and support the quality level of the entire organization Infrastructure components are the main tools employed to prevent software errors and support the quality level of the entire organization. avoidance lowering faults rates improving the productivity. Goal of infrastructure are the avoidance of software faults, lowering faults rates and improving the productivity.

3. INFRASTRUCTURE COMPONENTS The infrastructure components are: Quality support devices like templates and checklists Staff SQA training and certification activities ( Chapter 16 ) Staff SQA training and certification activities ( Chapter 16 ) Preventive and corrective actions ( Chapter 17 ) Preventive and corrective actions ( Chapter 17 ) Software configuration management ( Chapter 18) Software configuration management ( Chapter 18) Documentation and quality records control.

4. C ASE S TUDY SURPRISES FOR THE “3S” DEVELOPMENT TEAM – C ASE S TUDY Team 7 of “3S – Sahara Software Specialists” started a new project for Apollo Ltd seven weeks late because of delays in completion of the previous project. Harshly pressured for time, the team leader decided to cancel the scheduled five-day training course on the new generator to be used for subsystem F, as required by the contract. He believed that the manuals supplied by the customer would be an adequate substitute for the course. This decision proved to be very costly. The two team members responsible for subsystem F found it very difficult to apply a generator they had never used. In addition to the three days spent receiving expert advice, they were forced to spend 25 working days more than were scheduled to complete the subsystem. Then, within the space of two weeks, two of the team’s six programmers resigned and left..

5. C ASE S TUDY SURPRISES FOR THE “3S” DEVELOPMENT TEAM – C ASE S TUDY As no programmers could be shifted in-house, management turned to an employment agency and requested that they find replacements as quickly as possible. The team leader was relieved as the urgently needed programmers were located and recruited, on a temporary basis, within a few days. Both new team members were experienced programmers. This arrangement seemed to suit the situation wonderfully as it will help in completing the project with minimal delay Considering the project’s unexpected difficulties – the training problems and the resignation of the two programmers – the team felt very lucky to manage to complete the programming stage by 11 November, only 11 days behind schedule.

6. C ASE S TUDY SURPRISES FOR THE “3S” DEVELOPMENT TEAM – C ASE S TUDY The team’s troubles began with the issuance of the testers’ report three weeks later. Together with a long list of minor defects, the report mentioned numerous severe faults in some units. All units of the faulty subsystem were programmed by one of the temporary programmers recruited by the agency, who had already left the company. The two team members who were directed to repair the units were confronted with unexpected difficulties: in addition to programming errors and incorrect understanding of the relevant design documents, the coding did not comply with any company coding procedures or work instructions. Later, they concluded that the temporary programmer professional qualifications were far below those claimed in his letters of recommendation. After investing several days in attempts to correct the errors, four out of the five units were recoded because all efforts to repair the existing code came to nothing. In the end, six exhausting weeks were spent on bringing these units up to shape.

7. C ASE S TUDY SURPRISES FOR THE “3S” DEVELOPMENT TEAM – C ASE S TUDY seven weeks behind schedule team leader concluded that had proven to be quite costly!!!  At this point, seven weeks behind schedule, the team leader concluded that the “super saver strategy” applied to training, as well as the “super short-cut procedure” implemented in recruitment, instruction and follow-up, had proven to be quite costly!!!.

8. S TAFF TRAINING AND CERTIFICATION Chapter ‘16’

9. S TAFF TRAINING AND CERTIFICATION The main objectives of training and certification: To develop the knowledge and skills needed assure To develop the knowledge and skills needed by new employees and to update the knowledge and skills of expert employees to assure efficient and effective task performance. To impart knowledge of structure procedures assure To impart knowledge of structure procedures and work instructions to assure matching of software products to the organization’s standards. To impart knowledge of SQA procedures To impart knowledge of SQA procedures. assure conform to the position’s requirements To assure that the qualifications of candidates for key professional positions conform to the position’s requirements.

10. T HE TRAINING AND CERTIFICATION PROCESS The training and certification process activities: Determine the professional knowledge requirements for each position. Determine the professional training and updating needs. Plan the professional training program. Plan the professional updating program. Define positions requiring certification. Plan certification processes. Deliver training, updating and certification programs. Perform follow-up of trained and certified staff.

11. T HE TRAINING AND CERTIFICATION PROCESS

12. D ETERMINING TRAINING AND UPDATING NEEDS comparison of the staff’s current knowledge with the updated knowledge requirements. Training and updating needs are determined by comparison of the staff’s current knowledge with the updated knowledge requirements. three different groups of staff: The type of training is adapted to the needs of three different groups of staff: Training: Training: for new employees, according to their designated assignment Retraining: Retraining: for employees assigned to new positions or receiving new assignments Updating: Updating: for staff members as demanded by their position.

13. D EFINING POSITIONS REQUIRING CERTIFICATION requires extreme care Assignment of personnel to key positions in software development and maintenance organizations requires extreme care. Examples of positions requiring certification of their Expertise are: Software development team leader, Software development team leader, Programming team leader, Programming team leader, Software testing team leader, Software testing team leader, Software maintenance technician Software maintenance technician Quality inspector Quality inspector

14. P LANNING THE CERTIFICATION PROCESSES A certification committee A certification committee defines the list of positions that require certification. certification differs by firm or organization. The list of positions that require certification differs by firm or organization. reflect the The details of the certification process reflect the organization special uniqueness, areas of specialization, software development and maintenance tools, customers and so on..

15. T YPICAL CERTIFICATION REQUIREMENTS A typical certification process requires meeting some or even all of the following requirements: Professional education Professional education Internal training courses Internal training courses Professional experience in the organization Professional experience in the organization (may be replaced by experience in other organizations) Assessment of achievements and abilities Assessment of achievements and abilities Evaluation by the candidate’s direct superior Evaluation by the candidate’s direct superior (often by completion of a special questionnaire) Demonstration of knowledge and skills by means of a test or a project Demonstration of knowledge and skills by means of a test or a project

16. E XAMPLE : C ERTIFICATION REQUIREMENTS AT SKF A DVANCED S OFTWARE / PROGRAMMING TEAM LEADER SKF Advanced Software Position Certification Document Position – Programmer team leader Approved by C. Haley Position: Chief software engineer Certification requirements Professional education. Two options – (a) BA or BSc in software engineering or an equivalent degree, or (b) Technician or equivalent degree in software engineering granted by a recognized school. Internal training courses. Two required courses – (1) Project management: 5-day course. (2) Advanced project management: 5-day course. Professional experience in the organization. For candidates holding a technician’s degree – three years of experience as a programmer in SKF. For candidates holding an academic degree – two years of experience as a programmer in SKF. For candidates having over five years of recognized experience as a programmer or programming team leader in another organization.

17. Performance evaluation. The average score of each of the last two performance evaluation will not fall below 3.8 (out of a maximum of 5). Targeted evaluation by candidate’s direct superior. The score of each of the eight items in the questionnaire will be no less than 3 (out of 5), with an average score of all items of at least 3.8. Demonstration of knowledge and skill by means of a test or project. test of programming skills according to a specially selected software design document. Minimum grade: 80. Responsibility for certification Overall responsibility. Chief software engineer. Responsibility for skill demonstration test. Manager of the relevant software development department. E XAMPLE : C ERTIFICATION REQUIREMENTS AT SKF A DVANCED S OFTWARE / PROGRAMMING TEAM LEADER

18. P REVENTIVE AND CORRECTIVE ACTIONS Chapter ’17’

19. P REVENTIVE AND CORRECTIVE ACTIONS to eliminate the causes of those defects throughout software development departments. These activities are not intended to deal with immediate correction of detected defects but to eliminate the causes of those defects throughout software development departments. completion of functional and managerial requirements while reducing the costs of carrying out software development, maintenance and quality assurance activities The main objective is the completion of functional and managerial requirements while reducing the costs of carrying out software development, maintenance and quality assurance activities.

20. E XAMPLE Case Study the corrective actions will be: for the “3S” development team – Case Study the corrective actions will be: (1) The training procedure should be updated to include a clause that requires a special consultant to support team members in case of lack of ability to undertake needed training prior to the introduction of new applications. (2) Programmers should be added to the list of positions requiring certification (3) Appointment of a mentor for a minimum period of three months for new department employees and two months for employees changing positions should be added to the recruiting procedure. (4) It was decided that all the Department’s teams would begin to use Version 6.1 within the next three months as it exceed the previous Version 5.1 in terms of quality and productivity.

21. T HE CORRECTIVE AND PREVENTIVE ACTIONS PROCESS Successful operation of a CAPA process includes the following activities: Information collection Analysis of information Development of solutions and improved methods Implementation of improved methods Follow-up. overview of the process  A schematic overview of the process is shown in Figure 17.1..

22. T HE CORRECTIVE AND PREVENTIVE ACTIONS PROCESS

23. I NFORMATION COLLECTION Internal sources of information are: (1) Software development process, (2) Software maintenance, (3) SQA infrastructure (4) Software quality management procedures. External sources of information are mainly: Customers’ application statistics Customer complaints.

24. I NTERNAL INFORMATION SOURCES AND DOCUMENTS Software development process Design review reports Inspection reports Walkthrough reports Experts’ opinion reports Test reviews Special reports on development failures and successes Proposals suggested by staff members.

25. Software quality management procedures class of sources Project progress reports Software quality metrics reports Software quality cost reports Proposals of staff members. I NTERNAL INFORMATION SOURCES AND DOCUMENTS

26. E XTERNAL INFORMATION SOURCES External information sources Customer complaints Customer service statistics Customer-suggested proposals. analysis The analysis of the collected information as reported in different documents is the subject of the next section.

27. A NALYSIS OF COLLECTED INFORMATION Regular operation of the CAPA process is expected to create a massive flow of documents related to a wide range of information. Analysis involves: are reviewed by professionals Screening the information and identifying potential improvements. Documents received from the various sources of information are reviewed by professionals in order to identify potential opportunities for CAPA.

28. A NALYSIS OF COLLECTED INFORMATION Analysis of potential improvements. Analysis of potential improvements. Efforts are directed to determine: Types and levels of damage Types and levels of damage resulting from the identified fault. Causes for faults. -differs from work instructions and procedures, -insufficient technical knowledge, -extreme time and/or budget pressures due to unrealistic estimates, -lack of experience with new development tools. Causes for faults. Typical causes are: -differs from work instructions and procedures, -insufficient technical knowledge, -extreme time and/or budget pressures due to unrealistic estimates, -lack of experience with new development tools. To estimate the total damage expected To estimate the total damage expected and to determine the priority of each fault case. Set priorities for solution Set priorities for solution of identified faults.

29. D EVELOPMENT OF SOLUTIONS AND THEIR IMPLEMENTATION Solutions are required to: Eliminate return Eliminate return of the types of faults detected. to improved efficiency Contribute to improved efficiency by enabling higher productivity.

30. D EVELOPMENT OF SOLUTIONS Several directions for solutions are commonly taken: 1) Updating relevant procedures. 1) Updating relevant procedures. (e.g. changes of employee recruitment procedures, changes of the maximum and minimum number of participants in a formal design review). 2) Shifting to a development tool 2) Shifting to a development tool that is more effective and less prone to the detected faults. 3) Improvement of reporting methods, 3) Improvement of reporting methods, including changes in report content, frequency of reporting and reporting tasks. 4) plans for training, retraining or updating staff.

31. D EVELOPMENT OF SOLUTIONS The “3S” case study displays six instances of CAPA: (1), and (2)) Updating of existing procedure (recommendations (1), and (2)) (3)) Replacement of development tools of low efficiency and effectiveness by better tools (recommendation (3)) (4)) Improvement in the operation of SQA infrastructure tools (recommendation (4)).

32. E XAMPLE : H IGH PERCENTAGE OF SEVERE DEFECTS a high quantity of software defects in the projects completed by two of its six teams. Analysis of software quality metrics for the Development Department identified a high quantity of software defects in the projects completed by two of its six teams. resources these teams required to correct the defects were higher than other teams. It was also found that the resources these teams required to correct the defects were higher than other teams. analysis was based on documented information related to The analysis was based on documented information related to the two teams’ current as well as former projects, in addition to projects performed by the four “healthy” teams.

33. EXAMPLE : HIGH PERCENTAGE OF SEVERE DEFECTS an important difference in the number of applications inspected Inquiries related to the SQA tools revealed an important difference in the number of applications inspected, especially in the analysis and design stages. the other teams used inspections quite lightly While the “healthy” teams treated inspection as a standard procedure for the more complicated functions, the other teams used inspections quite lightly. to introduce definitions of the function types requiring inspection The recommended CAPA solution was to introduce definitions of the function types requiring inspection within the inspection work instructions.

34. E XAMPLE B: E XAMPLE B: I NCREASE IN HELP DESK CALLS THAT REQUIRE SERVICE AT THE CUSTOMER ’ S SITE  This example shows how a CAPA process can produced unexpected findings and recommendations. Team 1 Team 2 The “Perfect Programming Company” operates two help desk teams to support users of its two most popular software products: Team 1 specialize in point of sale (POS) packages, Team 2 in accountancy packages. planned new quality metrics to support control of the teams’ efficiency. The Help Desk Unit’s management planned new quality metrics to support control of the teams’ efficiency. the control of services performed at the customer’s site kept track of two variables: These new metrics highlighted the control of services performed at the customer’s site, due to their high costs, and kept track of two variables: The percentage of customer site visits and The percentage of customer site visits and The average technician time per site visit. The average technician time per site visit.

35. E XAMPLE B Team 2 a dangerous change in Team 1 ’s performance was observed The report for the fourth quarter made a warning signal among company management. Whereas Team 2 showed stability in its performance, a dangerous change in Team 1 ’s performance was observed. Management was very concerned by the large increase in the percentage of customer’s site visits and average technician time per site visit.

36. E XAMPLE B CAPA team A corrective and preventive action team (CAPA team) was appointed. The CAPA team The CAPA team held three long meetings devoted to interviewing the help desk team leaders, reviewing a sample of their customer’s site visit reports examining their detailed monthly statistical reports  The team also observed the help desk teams at work during one afternoon.

37. E XAMPLE B Team 2 a year of major changes Team 1 The CAPA team discovered that while the previous year was normal for Team 2, it had been a year of major changes in the operations of Team 1. Team 1 had invested large efforts in improvement of the user interface of the POS During the first and second quarters, Team 1 had invested large efforts in improvement of the user interface of the POS package and added several helpful error messages. new Version 6.4 that replaced the Version 6.3 All these improvements were included in the new Version 6.4 that replaced the Version 6.3 of the POS packages Version 6.4 during the third quarter. Version 6.4 had been installed by most users during the third quarter. Team 1 achieved a large reduction of total help desk efforts Unexpectedly, in the last two quarters Team 1 had actually achieved a large reduction of total help desk efforts, as measured in hours of help desk service per customer.

38. MORE COMPREHENSIVE R EPORT E XAMPLE B - MORE COMPREHENSIVE R EPORT

39. E XAMPLE B dramatic decrease in the number of user calls was observed as a result of the new version A dramatic decrease in the number of user calls was observed, as a result of the new version of the packages. was due to the higher percentage of services The increase in average time spent at a customer’s site visit was due to the higher percentage of services now given to new customers. Two corrective actions The CAPA team proposed Two corrective actions : report more comprehensive one To replace the currently used report by a more comprehensive one, based on the lines of Table 17.2. Team 2 suggested to achieve a large improvement in the team’s performance An inquiry into the practices implemented by Team 2 was suggested to achieve a large improvement in the team’s performance.

40. F OLLOW - UP OF ACTIVITIES Three main follow-up tasks Three main follow-up tasks are necessary for the proper functioning of a corrective and preventive action process in any organization: Follow-up of the flow of development and maintenance CAPA records from the various sources of information. have been performed in practice. Follow-up of implementation. This activity is intended to indicate whether the designated actions – training activities, replacement of development tools, procedural changes– have been performed in practice. have achieved the expected results. Follow-up of outcomes. Follow-up of the improved methods’ actual outcomes, enables assessment of the degree to which corrective or preventive actions have achieved the expected results.

41. PARTICIPANTS IN THE CAPA PROCESS joint efforts The CAPA process is carried out by the joint efforts of a stable CAPA body together with ad hoc team participants. The stable CAPA body The stable CAPA body, commonly called the CAB, activates the CAPA process by screening information, appointing members of targeted ad hoc CAPA teams, promoting implementation and following up the process. The ad hoc CAPA team’s The ad hoc CAPA team’s task is to analyze information about a given topic in addition to developing and solutions and a CAPA implementation process. Most members of ad hoc CAPA teams are department staff members experienced in the subject matter.

42. QUIZ Briefly describe the CAPA Process. List out the directions for CAPA solutions.