registration management committee (rmc) other party (op) assessor workshop january 16, 2009 –...

Registration Management Committee (RMC)Other Party (OP) Assessor WorkshopJanuary 16, 2009 – Orlando FL

Roles & ResponsibilitiesRoles & Responsibilities

Pre- and Post- Pre- and Post-

Assessment ActivityAssessment Activity

Lori Scheid-GillespieLori Scheid-Gillespie

Accreditation Manager (ANAB)Accreditation Manager (ANAB)


CB Office AssessmentCB Office Assessment

Lori Scheid-GillespieLori Scheid-Gillespie

Accreditation Manager (ANAB)Accreditation Manager (ANAB)


CB Office Assessment & Witness CB Office Assessment & Witness Assessment SchedulingAssessment SchedulingNote: other AB processes may varyNote: other AB processes may vary

• AB confirmation letter sent to OEM primary AB confirmation letter sent to OEM primary contact contact

• OEM notify AB of assigned OP assessorOEM notify AB of assigned OP assessor– AB to update the Oversight Spreadsheet with AB to update the Oversight Spreadsheet with

OP assessor information (for OEM & AB use)OP assessor information (for OEM & AB use)

• OEM primary contact to notify their OP assessor OEM primary contact to notify their OP assessor


CB Office Assessment & Witness CB Office Assessment & Witness Assessment SchedulingAssessment SchedulingNote: other AB processes may varyNote: other AB processes may vary

• AB notifies their assessment team with the OP AB notifies their assessment team with the OP Assessor contact infoAssessor contact info

• AB team lead will contact the OP assessor AB team lead will contact the OP assessor directlydirectly– May not be right away; may be closer to the May not be right away; may be closer to the

assessment for open meeting planning.assessment for open meeting planning.


CB Office Assessment ~CB Office Assessment ~ OP Assessor Role OP Assessor Role

• OP Assessor serves as team memberOP Assessor serves as team member

• Roles & Responsibilities covered in previous Roles & Responsibilities covered in previous presentationpresentation

AS9104-2 (9)AS9104-2 (9)


CB Office AssessmentCB Office Assessment Preparation Preparation

Documents needed to perform assessment:Documents needed to perform assessment:

• Requirement DocumentsRequirement Documents• CB Procedures related to AS programCB Procedures related to AS program• AS9104-2 Appendix F (CB Office AS9104-2 Appendix F (CB Office

Assessment Checklist)Assessment Checklist)• AS9104-2 Appendix K (Oversight AS9104-2 Appendix K (Oversight

Assessment Summary Report)Assessment Summary Report)• Assessment PlanAssessment Plan• Document Review (if applicable)Document Review (if applicable)


CB Office AssessmentCB Office Assessment Planning Planning

• CB documents are received by the AB (from the CB documents are received by the AB (from the CB) approx. 4 weeks prior to the assessmentCB) approx. 4 weeks prior to the assessment

• AB sends the info to assigned OP assessor (NOT AB sends the info to assigned OP assessor (NOT including standards / requirement documents) including standards / requirement documents) – If the OEM assessor has yet to be assigned; If the OEM assessor has yet to be assigned;

AB sends the info to the OEM main contactAB sends the info to the OEM main contact

• Information may include:Information may include:– Logistic info (hotel, directions)Logistic info (hotel, directions)– Assessment Plan - Assessment Plan - ISO 19011 (6.4)ISO 19011 (6.4)– CB documented processes for assessmentCB documented processes for assessment– Other documentation as required by the ABOther documentation as required by the AB


CB Office AssessmentCB Office Assessment Planning Planning

Joint Assessment Prep (by OEM assessor) Joint Assessment Prep (by OEM assessor) ISO ISO 19011 (6.4)19011 (6.4)

• Review AB assessment plan to gain an Review AB assessment plan to gain an understanding of what will be assessed understanding of what will be assessed

• Review appropriate parts of the standards to re-Review appropriate parts of the standards to re-fresh your memory.fresh your memory.

• ANAB team lead to schedule a pre-assessment ANAB team lead to schedule a pre-assessment meeting with OP Assessor to meet and discuss meeting with OP Assessor to meet and discuss plan and remind OP Assessor of basic processplan and remind OP Assessor of basic process


CB Office AssessmentCB Office Assessment Conduct Conduct

• What to assess included in the Body of What to assess included in the Body of Knowledge presentationKnowledge presentation

• Try and keep current with record review (past Try and keep current with record review (past year or so).year or so).

• Try and work independently with limited Try and work independently with limited assistance from the AB.assistance from the AB.


CB Office AssessmentCB Office Assessment : Post Activities : Post Activities

• Final steps:Final steps:– Identify Findings and notify the AB team lead - Identify Findings and notify the AB team lead -

AS9104-3 (8.6.2)AS9104-3 (8.6.2)

• If AB lead is not in agreement; notify the AB If AB lead is not in agreement; notify the AB & RMC via & RMC via AS9104-3 (Appendix K)AS9104-3 (Appendix K)

• If AB lead is in agreement no need to If AB lead is in agreement no need to document findings on Appendix K.document findings on Appendix K.



• Final steps:Final steps:

– AB (with OP assessor) to establish AB (with OP assessor) to establish conclusions & prepare NCR’s - conclusions & prepare NCR’s - ISO 17011 (7.8)ISO 17011 (7.8)

– AB to conduct closing meeting - AB to conduct closing meeting - ISO 17011 ISO 17011 (7.8)(7.8)



• AB to generate Assessment report – AB to generate Assessment report – ISO 17011 (7.8)ISO 17011 (7.8)

• OP Assessor to complete AS9104-3 (Appendix F & OP Assessor to complete AS9104-3 (Appendix F & K) and provide to the AB and OEM main contactK) and provide to the AB and OEM main contact

– Appendix F will be incorporated into the AB’s Appendix F will be incorporated into the AB’s Appendix FAppendix F

• Can also just submit notes to the AB and not Can also just submit notes to the AB and not the appendix.the appendix.

– Appendix K will be provided to the AAQG RMC Appendix K will be provided to the AAQG RMC Oversight Chair for review.Oversight Chair for review.



• AB to manage the NCR / corrective action process AB to manage the NCR / corrective action process with CB – with CB – ISO 17011 (7.8)ISO 17011 (7.8)

• AB ensures effective cause, correction, AB ensures effective cause, correction, corrective actioncorrective action

• AB establishes timeframes and approves AB establishes timeframes and approves extensions (if applicable)extensions (if applicable)

• OEM may request a copy of AB’s assessment report– If requested AB sends the information to the

OEM main contact


CB Witness AssessmentCB Witness Assessment


CB Witness AssessmentCB Witness Assessment – OP Assessor – OP Assessor RoleRole• OP Assessor serves as an AB team memberOP Assessor serves as an AB team member

• Roles & Responsibilities covered in previous Roles & Responsibilities covered in previous presentation; however,presentation; however,

• During Witness AssessmentDuring Witness Assessment– Silently observeSilently observe– Do not influence outcome of Assessment!Do not influence outcome of Assessment!– Do not talkDo not talk– Do not make body motions to show approval Do not make body motions to show approval

or disapprovalor disapproval– Do not answer questions of organization (or Do not answer questions of organization (or

CB)CB)

AS9104-2 (8.2, 9)AS9104-2 (8.2, 9)


CB Witness Assessment CB Witness Assessment PreparationPreparation• Documents needed to perform the Witness Documents needed to perform the Witness

AssessmentAssessment

• Requirement DocumentsRequirement Documents• CB Procedures related to AS auditCB Procedures related to AS audit• AS9104-2 Appendix G (CB Witness AS9104-2 Appendix G (CB Witness

Assessment Checklist)Assessment Checklist)• AS9104-2 Appendix K (Oversight AS9104-2 Appendix K (Oversight

Assessment Summary Report)Assessment Summary Report)• CB Audit PlanCB Audit Plan• CB document review (if applicable)CB document review (if applicable)


CB Witness AssessmentCB Witness Assessment Planning Planning

• CB documents are received by the AB (from the CB documents are received by the AB (from the CB) approx. 4 weeks prior to the Witness CB) approx. 4 weeks prior to the Witness AssessmentAssessment

• AB sends the info to assigned OP Assessor (NOT AB sends the info to assigned OP Assessor (NOT including standards / requirement documents) including standards / requirement documents) – If the OP Assessor has yet to be assigned; AB If the OP Assessor has yet to be assigned; AB

sends the info to the OEM main contactsends the info to the OEM main contact



• Information may include:Information may include:– Logistic info (hotel, directions)Logistic info (hotel, directions)– CB Audit Plan - CB Audit Plan - ISO 19011 (6.4ISO 19011 (6.4))– CB audit team’s credentials (e.g. resume)CB audit team’s credentials (e.g. resume)– CB documented processes for auditCB documented processes for audit– Other documentation as required by the ABOther documentation as required by the AB



Joint Assessment Prep (by OEM assessor) Joint Assessment Prep (by OEM assessor) ISO ISO 19011 (6.4)19011 (6.4)

• Allow approx. 2 hours AFTER the CB’s end time Allow approx. 2 hours AFTER the CB’s end time to allow for the AB closing meetingto allow for the AB closing meeting

• Review CB audit plan - Review CB audit plan - ISO 19011 (6.4) ISO 19011 (6.4) to gain an to gain an understanding of what will be auditedunderstanding of what will be audited

• Review all documentation to gain a knowledge Review all documentation to gain a knowledge and an understanding of the CB’s processes.and an understanding of the CB’s processes.

• Review CB audit team’s credentials to confirm Review CB audit team’s credentials to confirm acceptabilityacceptability

• Review organization’s information to understand Review organization’s information to understand scope, etc.scope, etc.

• Review OASIS (if organization is certified)Review OASIS (if organization is certified)• Review appropriate parts of the standards to re-Review appropriate parts of the standards to re-

fresh your memory.fresh your memory.



• ANAB team lead to schedule a pre-assessment ANAB team lead to schedule a pre-assessment meeting with OP Assessor to meet and discuss meeting with OP Assessor to meet and discuss plan and remind OP Assessor of basic process. plan and remind OP Assessor of basic process.

– This may be done during the AB/CB opening This may be done during the AB/CB opening meetingmeeting


CB Witness Assessment: CB Witness Assessment: Post ActivityPost Activity• Final steps:Final steps:

– Identify Findings and notify the AB team lead - Identify Findings and notify the AB team lead - AS9104-2 (8.2.5)AS9104-2 (8.2.5)

• If AB lead is not in agreement; notify the AB If AB lead is not in agreement; notify the AB & RMC via & RMC via AS9104-3 (Appendix K)AS9104-3 (Appendix K)

• If AB lead is in agreement no need to If AB lead is in agreement no need to document findings on Appendix K.document findings on Appendix K.


CB Witness Assessment: CB Witness Assessment: Post ActivityPost Activity• Final steps:Final steps:

– AB (with OP assessor) to establish AB (with OP assessor) to establish conclusions & prepare NCR’s - conclusions & prepare NCR’s - ISO 17011 (7.8)ISO 17011 (7.8)

– AB to conduct closing meeting - AB to conduct closing meeting - ISO 17011 ISO 17011 (7.8)(7.8)• AFTER CB’s closing meeting with AFTER CB’s closing meeting with

organization.organization.• OP Assessor to participate in the closing OP Assessor to participate in the closing

meeting.meeting.


CB Witness AssessmentCB Witness Assessment: Post Activities: Post Activities

• AB to generate assessment report – AB to generate assessment report – ISO 17011 (7.8)ISO 17011 (7.8)

• OP Assessor to complete AS9104-3 (Appendix G & OP Assessor to complete AS9104-3 (Appendix G & K) and provide to the AB and OEM main contactK) and provide to the AB and OEM main contact

– Appendix G will be incorporated into the AB’s Appendix G will be incorporated into the AB’s Appendix G.Appendix G.

• Can also just submit notes to the AB and not Can also just submit notes to the AB and not the appendix.the appendix.

– Appendix K will be provided to the AAQG RMC Appendix K will be provided to the AAQG RMC Oversight Chair for review.Oversight Chair for review.


CB Witness AssessmentCB Witness Assessment: Post Activities: Post Activities

• AB to manage the NCR / corrective action AB to manage the NCR / corrective action process with CB – process with CB – ISO 17011 (7.8)ISO 17011 (7.8)

• AB ensures effective cause, correction, AB ensures effective cause, correction, corrective actioncorrective action

• AB establishes timeframes and approves AB establishes timeframes and approves extensions (if applicable)extensions (if applicable)

• OEM may request a copy of AB’s assessment OEM may request a copy of AB’s assessment reportreport– If requested AB sends the information to the If requested AB sends the information to the

OEM main contactOEM main contact


Appendix CompletionAppendix Completion

• F – CB Office AssessmentsF – CB Office Assessments• G – CB Witness Assessments G – CB Witness Assessments – Joint – can complete if want; AB shall Joint – can complete if want; AB shall

completecomplete– Independent – must completeIndependent – must complete

• K – All Assessments must be completedK – All Assessments must be completed– Provide to the AB Lead Assessor ASAP Provide to the AB Lead Assessor ASAP

• preferably prior to the end of the assessmentpreferably prior to the end of the assessment• If not on-site, via e-mail to AB Lead AssessorIf not on-site, via e-mail to AB Lead Assessor

– Reviewed by RMC Oversight Chair (currently Reviewed by RMC Oversight Chair (currently Susie Neal) and summarized for RMCSusie Neal) and summarized for RMC


Lessons Learned Lessons Learned

over the years on joint assessmentsover the years on joint assessments


Lessons Learned Lessons Learned Scheduling Joint ActivityScheduling Joint Activity

• OEM to identify assessor to conduct OEM to identify assessor to conduct assessments ASAP (and notify AB)assessments ASAP (and notify AB)

• OEM to notify AB of any assessor changes ASAPOEM to notify AB of any assessor changes ASAP– ANAB to notify all parties of assessor change ANAB to notify all parties of assessor change – Make sure replacement is qualified.Make sure replacement is qualified.

• After the confirmation letter (which can come After the confirmation letter (which can come months prior to an assessment) an OEM will not months prior to an assessment) an OEM will not get another notice of the assessment until a few get another notice of the assessment until a few weeks prior to the assessment.weeks prior to the assessment.


Lessons Learned Lessons Learned Preparation for Joint ActivityPreparation for Joint Activity

• OP assessor mustOP assessor must– Be qualified/trainedBe qualified/trained– Have knowledge of the standardsHave knowledge of the standards– Have a copy of the standardsHave a copy of the standards– Have signed and turned in Appendix IHave signed and turned in Appendix I– Have post-activity forms to completeHave post-activity forms to complete

All to be provided by OEM not by the AB.All to be provided by OEM not by the AB.


Lessons Learned Lessons Learned CB CB Office Assessment ConductOffice Assessment Conduct

• Not conducting 2Not conducting 2ndnd party audits party audits

• Caution with conflict of interest and Caution with conflict of interest and confidentiality.confidentiality.– Acquiring information for OEM procurement Acquiring information for OEM procurement

process is not acceptable.process is not acceptable.


Lessons Learned Lessons Learned CB Witness Assessment ConductCB Witness Assessment Conduct

• Organization may ask questions about the Organization may ask questions about the oversight; OP assessor may have to explain the oversight; OP assessor may have to explain the oversight process (during opening meeting, oversight process (during opening meeting, breaks, etc)breaks, etc)

• Asking simple questions and/or making simple Asking simple questions and/or making simple comments during Witness Assessment is comments during Witness Assessment is considered interfering.considered interfering.

• Picking up records, materials, parts, etc. is Picking up records, materials, parts, etc. is considered interferingconsidered interfering

• Talking to the AB assessor team is distracting Talking to the AB assessor team is distracting during the audit.during the audit.

• Not conducting 2Not conducting 2ndnd party audits party audits


Lessons LearnedLessons LearnedJoint Assessment Post-ActivityJoint Assessment Post-Activity

• OEM assessors to complete AS9104-2 OEM assessors to complete AS9104-2 appendices in a timely manner.appendices in a timely manner.

• If a decision is appealed by CB; be available to If a decision is appealed by CB; be available to participate in appeal hearing.participate in appeal hearing.


Questions / CommentsQuestions / Comments