Training

1. Training

2. Why Train? • skills and knowledge needed by new staff • update skills of old staff • assure conformity to standards • teach the proper use of SQA procedures and their purpose • because ISO and CMM say so blatant steal from Galin

3. What topics need training? • Software Engineering (Development) • e.g. CASE tools, estimating tools, procedures for coding, … • when: when new staff are hired • big companies? • small companies? • SQA • e.g. testing tools and methods, peer-review procedures and checklists, … • when does SQA training occur? • probably reviewed annually • who gets SQA training?

4. Who does the training? • in-house training unit • vocational schools • commercial technical trainers When are these appropriate?

5. And most important… • Follow-up the training!!! Why follow-up? How do we follow-up?

6. CAPA Corrective and Preventive Actions

7. What is CAPA? • activities not intended to correct defects, but to eliminate the cause of those defects.

8. Reality Check... • How can we see into the future and fix problems that have not yet occurred? • corrective - fix past problems • preventive - predict potential problems

9. How to conduct CAPA • information collection • analysis of information • development of improved methods • implementation of improved methods • follow-up

10. What info gets analyzed? • Roundup the usual suspects… • design review reports • code walkthrough reports • test reports • project progress reports • customer complaint records • software change requests and maintenance reports • training follow-up reports • But don't forget… • special reports on quality / quality audits • suggestions / observations by staff

11. Ways to sift through that huge pile of records • asks the reporter to indicate a priority for their report • random sampling • combination of the two techniques above

12. When do you analyze that huge pile of records? • Answer 1 : After a plane crash. • Answer 2 : Every time a plane lands.

13. CAPA Outcomes • updating relevant procedures • updating relevant work procedures • changing tools • improvement of reporting methods • report contents • report frequency • changes in training • probably, several of the above

14. Side Topic:Control Charts • Common Cause and Special Cause • Lines: • Center Line = mean • Upper and Lower Control Limits (UCL and LCL) • Warning Limits • If the process is "in control", all points will plot within the control limits. • The control limits have no relationship to quality limits. adapted from: http://en.wikipedia.org/wiki/Control_chart

15. Common Cause and Special CauseWarning: Don't Overreact " 'A riot occurs in a certain prison. Officials and sociologists turn out a detailed report about the prison, with a full explanation of why and how it happened here, ignoring the fact that the causes were common to a majority of prisons, and that the riot could have happened anywhere.' The quote recognizes that there is a temptation to react to an extreme outcome and to see it as significant, even where its causes are common to many situations and the distinctive circumstances surrounding its occurrence, the results of mere chance. Such behavior has many implications within management, often leading to interventions in processes that merely increase the level of variation and frequency of undesirable outcomes."

16. Side Topic similar to Control Charts: Scatter Charts

17. Side TopicRelated to CAPA: PDCA • PLAN  • Establish the objectives and processes necessary to deliver results in accordance with the specifications. • DO  • Implement the processes. • CHECK • Monitor and evaluate the processes and results against objectives and specifications and report the outcome. • ACT • Apply actions to the outcome for necessary improvement. This means reviewing all steps (Plan, Do, Check, Act) and modifying the process to improve it before its next implementation. http://en.wikipedia.org/wiki/Plan_Do_Check_Act

18. And, of course, the obvious question • Why bother with CAPA?