2Transport Canada Civil Aviation Prairie Northern Region David WhiteSMS Coordinator PNROversight Coordination DivisionBased in Edmonton, Alberta(780)
3Contents Define surveillance activities Discuss surveillance procedures (SI-SUR-001)Refer to areas of review, SMS, QAP,Ops ControlAnalysing Issues identified during surveillanceCausal analysis (root cause)Generating acceptable Corrective Action Plans (CAP)Effective communication during the process3
4What is an Assessment?Assessment means the surveillance activity conducted to evaluate effectiveness and level of compliance with the CARs.Staff Instruction (SI) SUR-001Sometimes referred to as 17 PVIs.
5What is a PVI?A systematic review of one or more SMS components of an organization OR other regulated areas of a certificate holder.Used to determine if regulatory requirements are documented, implemented, in use and effective within certified organizations.It is a means to focus on the effectiveness of management systems & make judgments on performance.Quality Assurance (QA) and the Ops control system are examples of management systems
6Additional distinction between terms Assessment – Evaluation of entire SMSLimited to companies that meet SMS requirementsPVI – Evaluation of regulated area of company’s control system or specific SMS componentApplicable to all companiesProcess Inspection – In-depth review of steps to obtain specific outputOur focus will be on Assessments/ PVIs here today.
8Surveillance Procedures in SUR-001 NotificationTeam selectionPVI planPreliminary doc reviewDocumentation reviewTeam meetingSampling proceduresOn-site proceduresPVI team on-site briefingOn-site reviewInterviewingAnalysisPVI worksheetsFindingsExit meetingPVI reportPVI CAP proceduresPVI follow-up & closure
9Program Validation Inspection (PVI) PVI will review the following areas for certificate holder without Quality Assurance (QA) Program:Part III - Airport operator’s obligationsPart IV - Company operational control & supervisionPart VII - Subpart 3 or 4 - Company operational controlPart VII - Subpart 5 - Safety Oversight componentPart VIII - Operating certificate requirements
10Quality Assurance Program Regulations for certificate holders to have QAWill be implemented in phased mannerPVIs for Parts III, IV, VII & VIII without fully implemented QA Program use customized PVI worksheetsSUR-001 Appendix A contains expanded list of all PVI worksheets organized by operating rule
11Quality Assurance Program Certificate holders that have QAP:Inspectors use worksheet SUR-001 Appendix A Table 5.1 Quality AssuranceThis includes certificate pursuant to:CAR 561STD 566CAR 573Maintenance requirements for all Part IV & VII operators
12Some Examples of Worksheets referenced in SI-SUR-001 (k) TABLE 3.1 – Reactive Processes(l) TABLE 3.2 – Proactive Processes(m) TABLE 3.3 – Investigation & Analysis(n) TABLE 3.4 – Risk Management(p) TABLE 5.1 – Quality Assurance(r) Program Validation Inspection Worksheet – CAR 302(s) Program Validation Inspection Worksheet – CAR 406(t) Program Validation Inspection Worksheet – CAR 703/704(u) Program Validation Inspection Worksheet – CAR 801(ee) Program Validation Inspection Worksheet EASANOTE: These Worksheets are internal documents only
14Documentation ReviewDoc review 4-6 weeks before on-site review –AssessmentDoc review 1-2 weeks before on-site review –PVIIncludes review of all files & docs relevant to certificate holder and scope of the surveillance activityEnsure all reference manuals/docs are available & include latest amendmentsConfirm revision status of any manual subject to reviewReview approved manuals for conformance to standardIdentify areas that require further review during on-site.Develop specific questions for certificate holder and appropriate management based on intelligence gathered during review.
15“A general policy statement is not usually enough to satisfy requirements. Document review team members must verify that there is a policy in place and that it is support by an appropriately documented procedure or process as required ”This varies dependent on the area being reviewed and the type of certificate issued but is basically the “Write what you do and do what you write” principle.TC may request additional documentation if the initial submission does not meet the team’s requirement.
16Onsite Activities Entrance Meeting Interviews ( Management and selected employees)SamplingBased on size, scope and complexity of the organization.Determined through process in SI-SUR-001Used in conjunction with interviews to determine regulatory complianceNon-compliance issues IdentifiedPurpose of the activity is to determine regulatory compliance.Company briefing(s)Exit meeting
17Surveillance Findings We will concentrate on PVI examples today.Ineffective Quality AssuranceLoss of Operational ControlExamples of Non-compliance with regulatory requirements.Examples of Non-compliance with Company Policy/Procedures and processes.
18Surveillance Reporting Report generated with findings.Required actions determined through review with CA.Issues are typically handled through the Corrective Action Plan (CAP) process.Required additional actions are based on the severity of non-compliance issues identified.Additional actions may involve Certificate Action and/or Enhanced Monitoring.
19Review of Findings Recognizing the System Failure Addressing the immediate concernsCausal AnalysisPlanning the short-term correctionsPlanning the long term correctionsInforming TC
20Causal Analysis SI-SUR-001, Section 10.4 CAP Evaluation … A Root Cause Analysis of the Non-conformance:The certificate holder’s analysis shall include a summary of the root cause as well as any causal factors that may have contributed to the non-conformance. Even though the certificate holder may use a causal analysis method that is not familiar to the CAP reviewer (e.g.: MEDA process, “5 Why’s”, etc.), the certificate holder must be able to demonstrate how they arrived at the root cause and it should be clear what caused the non-conformance to occur.
21Causal AnalysisCausal Analysis seeks to identify and understand the reasons why things are as they are and hence enabling focus of change activity.Some Examples:The 5 WhysMedaFishboneThe key is just to keep asking until you get to a real 'aha' that you can treat.
22CAP Submission TC Inspector Expectations Causal Analysis Appropriate TimelinesDocumentationCommunicationSI SUR-001 Section 10.4 (2) states:*** “The role of the principal inspector responsible for the acceptance of the CAP shall be limited to the assessment of the process used by the certificate holder in reaching conclusions regarding the findings. It is not the inspector’s role to second-guess the CAP solutions, but rather to evaluate the process used in developing those solutions.”***
23CAP Acceptance and Follow-up Remember it is your PlanMonitor the implementation to ensure it is implementedCommunicate Issues if implementation not as per plan.Document the issues and resolution with the regulator.Be prepared for the Activity follow-up…Confirming your systems are working not just that the examples identified during the inspection have been addressed
24Surveillance Activity Closure Effective systems are a continuing process.Your responsibility for day to day complianceSystems will mature and improve as we continue to use them.