lead auditor course introduction

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

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http://www.medicaldeviceacademy.com/

mailto:[email protected]

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Our New Instructor



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Guidance Document – 13485 Plushttp://bit.ly/13485Plus

www.csa.ca

The Standards

ISO 9001:2008 ISO 13485:2003

ISO 14969:2004

ISO 14971:2007

ISO 17021:2006

ISO 19011:2011



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QSIT Subsystems• 4 Majors:

– Management Controls– Design Controls– Production & Process Controls

• Sterilization

– CAPA• MDRs• Corrections & Removals (i.e. – Recalls)

• 3 Minors:– Facilities & Equipment Controls– Material Controls– Document/Record/Change Controls

http://bit.ly/QSITManual108-page QSIT

Inspection Guide

QSIT Major Subsystem



http://bit.ly/QSITManual

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ISO 19011:2011

ISO 19011:2011 provides guidance on:• Auditing principles• Managing audit programs• Conducting internal and

external audits• Competence of auditors

ISO 19011 ReferencesNOTE



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Types of Audits

1st Party (Internal): Organization auditing its own system

2nd Party (External): Organization auditing its supplier

3rd Party (External):

Organization audited by a certification body

S

NOTE



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Interviewing ToolsOpen-ended Question (preferred)

Relies on why, who, what, where, when, or how to get more than a yes or no answer

Expansive Question Further elaborates the current point

Opinion Question Asks opinion about current pointNon-verbal Uses body language, for example: raise

eye-brow to elicit further information

Repetitive Question Repeats back response in form of question

Hypothetical Question

Uses what if, suppose that, etc.

Closed Question Gets a yes or no answer and used for confirmation (avoid using too often)

Silence Draws more information



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Note Taking• The documented requirement

(e.g. procedure # & document title)• Admissible statements from a

person responsible for the work• Details of the observation (e.g. part

#, product lot and sample size)• Reference to a written record/report

(e.g. publication date & record title)



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ChecklistsExample: GD210 Audit Checklist

Closed Questions Requiring Only a Yes/No Response



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Highlighting SOPs

NOT a requirement of ISO 13485

1. Review the Procedure2. Identify Procedural Requirements to Verify



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“Turtle” Diagram History

Process Name_______________

____

Process Steps/Activities:

_______________________________________________________________________________________________

_____

Inputs? Customer wants:

Input requirements. What are the inputs that determine what the process must produce?

With what?Machines/Equipment:

Materials:

With whom?People involved with this process:

Links/interfaces with involved parties:

Outputs? Customer need is fulfilled for:

Output requirements. What output criteria are used to determine that the output meets the requirements?

Measure?With what key criteria? Measurements/Assessments:

How?Support processes: (Who helps and how?)

Procedures/work instructions/control documents:

JAN ROOVERS ASSOCIATES, INC.

Plexus International Claims to have “invented” this.

Crosby’s Model

PROCESSI nternal Actions

Procedures/ Process Definition

Performance Standards

INPUTS

Equipment/Facilities Training/ Knowledge

OUTPUTS

JAN ROOVERS ASSOCIATES, INC.

With what?Resources

OutputsTo whom/

where

What results?Performance

indicators

InputsFrom

whom/ where

How done?Methods/

Documentation

With Whom?Personnel

Process(specific value

added activities)



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Metrics &Quality Objectives?

Step 7

Process OutputsProcess InputsStep 2 Step 3

With Whom?Ste

p 5

Procedures & Forms?

Step

6

With What EquipmentFacilities & Materials?

Step 4

Step 1: Describe the Process & Identify the

Process Owner

Process Approach to AuditingA.K.A. – Turtle Diagrams

http://bit.ly/Process-Approach





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Adjacent Link Auditing

Design Controls

Post-Market Surveillance

Risk Analysis – Input to Design Process

http://bit.ly/AdjacentLinkAuditing

Complaint HandlingSeveral Processes

CAPA &Management Review



http://bit.ly/AdjacentLinkAuditing

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Audit Agenda



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Generating Audit Findings Medical Device Academy Internal Audit

Nonconformity Report

Incident Number: 1

Company under Audit: XYZ, Inc.

Area under Review: Purchasing

ISO 13485 Clause Number: 4.2.3

Category: Major Minor Requirement: Document Control procedure #QSP-4.2.3, revision B, dated 10/15/2012 requires that all documents be reviewed, revised and approved by authorized personnel prior to release. Authorized personnel are identified in Appendix A, “Authorized Approval List”. Nonconformity: There is no evidence that Purchasing procedure # QSP-7.4, revision C, dated 02/23/2013 was approved by anyone listed on the “Authorized Approval List” that was in effect at the time the procedure was created.

Best Practice



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How to Register

http://bit.ly/Lead-Auditor-Course





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+1.561.308.3093

If you want this in-house…



lead auditor course introduction

Health & Medicine

rob packard

process owner process

process stepsactivities

design process http

standards iso

requirement of iso

closed question

turtle diagram history