Surveillance

1
Surveillance Findings/Analysis/CAPs ATAC 2010
2
Transport Canada Civil AviationPrairie Northern
Region

• David White
• SMS Coordinator PNR
• Oversight Coordination Division
• Based in Edmonton, Alberta
• [phone]
• david.white_at_tc.gc.ca

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

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.

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

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.

7
Surveillance Activity Overview

• The activity consists of
• Documentation review (preparation)
• On-site review (including interviews sampling)
• Analysis
• Reporting

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

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

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

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

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  
13
Surveillance Activity Responsibilities

• Convening Authority
• Identifies - Who
• Defines - Scope depth
• PVI/Assessment Manager
• Plans
• Manages
• Team Member(s)
• Conduct

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.

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.

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

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.

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.

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

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.

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.

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.

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

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.

25
Thank-you