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1 Surveillance Findings/Analysis/CAPs ATAC 2010 Slide 2 2 Transport Canada Civil Aviation Prairie Northern Region David White SMS Coordinator PNR Oversight Coordination Division Based in Edmonton, Alberta (780) 495-5216 david.white@tc.gc.ca Slide 3 3 Contents Define surveillance activities Discuss surveillance procedures (SI-SUR-001) Refer to areas of review, SMS, QAP,Ops Control Analysing Issues identified during surveillance Causal analysis (root cause) Generating acceptable Corrective Action Plans (CAP) Effective communication during the process Slide 4 4 What is an Assessment? Assessment means the surveillance activity conducted to evaluate effectiveness and level of compliance with the CARs. Staff Instruction (SI) SUR-001 Sometimes referred to as 17 PVIs. Slide 5 5 What 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 Slide 6 6 Additional distinction between terms Assessment Evaluation of entire SMS Limited to companies that meet SMS requirements PVI Evaluation of regulated area of companys control system or specific SMS component Applicable to all companies Process Inspection In-depth review of steps to obtain specific output Our focus will be on Assessments/ PVIs here today. Slide 7 7 Surveillance Activity Overview The activity consists of: Documentation review (preparation) On-site review (including interviews & sampling) Analysis Reporting Slide 8 8 Surveillance Procedures in SUR-001 Notification Team selection PVI plan Preliminary doc review Documentation review Team meeting Sampling procedures On-site procedures PVI team on-site briefing On-site review Interviewing Analysis PVI worksheets Findings Exit meeting PVI report PVI CAP procedures PVI follow-up & closure Slide 9 9 Program Validation Inspection (PVI) PVI will review the following areas for certificate holder without Quality Assurance (QA) Program: Part III - Airport operators obligations Part IV - Company operational control & supervision Part VII - Subpart 3 or 4 - Company operational control Part VII - Subpart 5 - Safety Oversight component Part VIII - Operating certificate requirements Slide 10 10 Quality Assurance Program Regulations for certificate holders to have QA Will be implemented in phased manner PVIs for Parts III, IV, VII & VIII without fully implemented QA Program use customized PVI worksheets SUR-001 Appendix A contains expanded list of all PVI worksheets organized by operating rule Slide 11 11 Quality Assurance Program Certificate holders that have QAP: Inspectors use worksheet SUR-001 Appendix A Table 5.1 Quality Assurance This includes certificate pursuant to: CAR 561 STD 566 CAR 573 Maintenance requirements for all Part IV & VII operators Slide 12 12 Some 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 EASA NOTE: These Worksheets are internal documents only Slide 13 13 Surveillance Activity Responsibilities Convening Authority Identifies - Who Defines - Scope & depth PVI/Assessment Manager Plans Manages Team Member(s) Conduct Slide 14 14 Documentation Review Doc review 4-6 weeks before on-site review Assessment Doc review 1-2 weeks before on-site review PVI Includes review of all files & docs relevant to certificate holder and scope of the surveillance activity Ensure all reference manuals/docs are available & include latest amendments Confirm revision status of any manual subject to review Review approved manuals for conformance to standard Identify areas that require further review during on-site. Develop specific questions for certificate holder and appropriate management based on intelligence gathered during review. Slide 15 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 teams requirement. Slide 16 16 Onsite Activities Entrance Meeting Interviews ( Management and selected employees) Sampling Based on size, scope and complexity of the organization. Determined through process in SI-SUR-001 Used in conjunction with interviews to determine regulatory compliance Non-compliance issues Identified Purpose of the activity is to determine regulatory compliance. Company briefing(s) Exit meeting Slide 17 17 Surveillance Findings We will concentrate on PVI examples today. Ineffective Quality Assurance Loss of Operational Control Examples of Non-compliance with regulatory requirements. Examples of Non-compliance with Company Policy/Procedures and processes. Slide 18 18 Surveillance 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. Slide 19 19 Review of Findings Recognizing the System Failure Addressing the immediate concerns Causal Analysis Planning the short-term corrections Planning the long term corrections Informing TC Slide 20 20 Causal Analysis SI-SUR-001, Section 10.4 CAP Evaluation A Root Cause Analysis of the Non-conformance: The certificate holders 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 Whys, 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. Slide 21 21 Causal Analysis Causal 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 Whys Meda Fishbone The key is just to keep asking until you get to a real 'aha' that you can treat. Slide 22 22 CAP Submission TC Inspector Expectations Causal Analysis Appropriate Timelines Documentation Communication SI 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 inspectors role to second- guess the CAP solutions, but rather to evaluate the process used in developing those solutions.*** Slide 23 23 CAP Acceptance and Follow-up Remember it is your Plan Monitor the implementation to ensure it is implemented Communicate Issues if implementation not as per plan. Document the issues and resolution with the regulator. Be prepared for the Activity follow-upConfirming your systems are working not just that the examples identified during the inspection have been addressed Slide 24 24 Surveillance Activity Closure Effective systems are a continuing process. Your responsibility for day to day compliance Systems will mature and improve as we continue to use them. Slide 25 25 Thank-you