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ISO 19011:2018(E) This document adopts the combined audit approach when two or more management systems of different disciplines are audited together Where these systems are integrated into a single management system the principles and processes of auditing are the same as for a combined audit (sometimes known as an integrated audit)

What are the ISO 19011 guidelines for auditing management systems?

  • The ISO 19011 Guidelines for auditing management systems has become the widely accepted standard for auditing not only management systems, but operational auditing in general. The newest edition of the standard, released in July 2018, has some important changes based on the experience gained from implementation of past editions.

What is ISO 19011:2002(E) 30?

  • ISO 19011:2002(E) 30 © ISO 2002 – All rights reserved ? certification/registration and accreditation requirements; ? the role of the audit process in the management of the organization to be audited; ? the level of confidence required in the audit programme; ? the complexity of the management system to be audited.

What is the ISO 19011:2002(E) PDF disclaimer?

  • ISO 19011:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.

Ombu Enterprises, LLC1

Sampling Plans for

Quality Audits

Dan O'Leary CBA, CQA, CQE, CRE, SSBB, CIRM

President

Ombu Enterprises, LLC

Dan@OmbuEnterprises.com

www.OmbuEnterprises.com OMBU

ENTERPRISES, LLC

©2019, Ombu Enterprises, LLC

Ombu Enterprises, LLC2

Topics

•Overview of a Quality Audit

•ISO 19011:2018

•Sampling Approaches to an Audit

•Statistics of Sampling

•Compliance Tests

•FDA Device Inspections

•Summary and Conclusions

•Questions

Ombu Enterprises, LLC3

Overview of a Quality Audit

Ombu Enterprises, LLC4

Data Collection and Analysis

•The auditor"s task is to:

-Collect factual audit evidence using the sampling method -Analyze that evidence -Evaluate the evidence against the audit criteria -Draw conclusions from the evaluation -Generate audit findings

Ombu Enterprises, LLC5

Audit Evidence

•The auditor obtains evidence from two primary sources: -Interviews of people involved in the process -Records generated by the process •Sampling methods apply to evidence obtained from records

Ombu Enterprises, LLC6

Procedures and Records

•Documented procedures, work instructions, and

drawings provide information on how to perform a process in a consistent manner.

•Records are a particular kind of document that provide objective evidence that activities have been performed or results have been achieved.

Ombu Enterprises, LLC7

Records

•ISO 9000:2015, 3.8.10 provides a definition for a record -Recordmeans a document stating results achieved or providing evidence of activities performed. •Because ISO 13485:2016 cites ISO 9000:2015 as a normative reference, this definition applies •FDA QSR does not define a record, but uses the term extensively

Ombu Enterprises, LLC8

Date, Information, and

Document Concepts

Source: ISO 9000:2015 Fig. A.11

Partial Diagram

Data (3.8.1)

Facts about an object

Information (3.8.2)

Meaningful data

Objective evidence (8.3.3)

Data supporting the existence or

verity of something

Document (3.8.5)

Information and the medium on

which it is recorded

Record (3.8.10)

Document stating results

achieved or providing evidence of activities performed

Specification (3.8.7)

Document stating

requirements

Documented information

(3.8.6)

Information required to be

controlled and maintained by an organization and the medium on which it is contained

Project management plan

(3.8.11) Document specifying what is necessary to meet the objectives of the project

Information system (3.8.4)

Network of communication

channels used within an organization

Ombu Enterprises, LLC9

Control of Records

•Following ISO 13485:2016, clause 4.2.5, a company should control two kinds of records: -Records established to provide evidence of conformity to requirements -Records established to provide evidence of the effective operation of the quality management system

Ombu Enterprises, LLC10

Control of Records

•Following ISO 13485:2016, clause 4.2.5, create documented procedures for record control including:

IdentificationStorageProtection

RetentionRetrievalDisposition

•Records must:

-Remain legible -Be readily identifiable -Be retrievable

Ombu Enterprises, LLC11

ISO 19011:2018

Ombu Enterprises, LLC

ISO 19011:2018

•ISO 19011:2018 Guidelines for Auditing Management

Systems

•Annex A Additional guidance for auditors planning and conducting audits

•Annex A.6 Sampling

12

Ombu Enterprises, LLC

Audit Sampling Steps

•Annex A.6.1 provides steps for audit sampling

-Establish the objectives of the sampling plan -Select the population to be sampled -Select the sampling method

•Judgement or Statistical

-Determine the sample size -Conduct the sampling -Compile, evaluate, document, and report the results •The report should include a description of the population, the sampling method, the size, estimates based on the sample, and the confidence level 13

Ombu Enterprises, LLC

Judgement Samples

•Annex A.6.2 discusses judgement sampling

-Relies on the knowledge, skill, and experience of the audit team

•Considerations include:

-Previous experience with the audit scope -Complexity of the requirements to meet the audit objectives -Complexity of the processes and the quality management system -Previously identified areas of risk -Previously identified areas of improvement •Judgement samples don"t provide a statistical estimate of the audit findings 14

Ombu Enterprises, LLC

Statistical Samples

•Annex A.6.3 discusses statistical sampling

•Use probability methods for the sample selection method -Attribute sampling for pass/fail, conforming/nonconforming, etc. -Variables sampling when the sample outcomes are continuous values •Sampling plans depend on the risk the auditor is willing to accept -This is usually called the acceptable confidence level -For example, a sampling risk of 5% corresponds to an acceptable confidence level of 95%

•The reported results should include:

-A description of the population sampled -The sampling criteria used the evaluate the sample -The statistical parameters and methods -The number of samples evaluated -The results 15

Ombu Enterprises, LLC16

Sampling

Ombu Enterprises, LLC17

Tracing

•Tracing follows a process:

-Forward tracing moves “downstream" -Backward tracing moves “upstream" -The Auditor could start in the middle and trace in either direction •Tracing establishes that the process and procedures operate as described •Unannounced visits for the EU-MDD often use backward tracing product audits starting with final acceptance

Ombu Enterprises, LLC18

Audit Overview

Collect Evidence

InterviewCheck Records

Judgment

SampleStatistical

Sample

Ombu Enterprises, LLC19

Judgment Samples

•Judgment samples don"t use statistical methods •The advantageis that judgment samples can often provide a “sense" of the process without a lot of work -Judgment samples tend to be smaller •The disadvantageis that judgment samples don"t allow the quantification of the results -Statistical samples tend to be larger

Ombu Enterprises, LLC20

Judgment Samples

•Judgment sampling relies on the knowledge, skills, and experience of the audit team.

•A drawback to judgment sampling is the lack of a statistical estimate of the effect of uncertainty in the findings of the audit and the conclusions reached.

Ombu Enterprises, LLC21

Compliance Tests

•Compliance tests show that process operation is satisfactory.

-These tests determine whether process control is effective by counting the number of nonconforming records

•Compliance tests use sampling methods

-Judgment samples may be acceptable -Statistical samples may be required (especially for critical processes)

Ombu Enterprises, LLC22

Contrasting the Methods

Tracing is an audit method to

follow the process, a process walk through. Tracing usually follows the process using procedures, flow charts, etc.

Compliance tests check the

records for existence, correctness, completeness, etc. based on the procedures and flow charts.

Ombu Enterprises, LLC23

Statistics of Sampling

Binomial Distribution

Confidence Intervals

Ombu Enterprises, LLC24

Judgment Samples

•Judgment samples rely on the knowledge and

experience of the auditor

•The Lead Auditor says to the audit team, “When you use judgment samples, look at 3, 5, 7, or 11 records."

•One team member asks why, and the Lead auditor responds, “I really like prime numbers".

Ombu Enterprises, LLC25

The Binomial Distribution

Ombu Enterprises, LLC26

The Bernoulli Trial

•Bernoulli trials are a sequenceof nindependenttrials, where each trial has only two possible outcomes.

•Example -Flip a coin fifty times

-This is a sequence of trials -n = 50 -The trials are independent, because the coin doesn't "remember" the previous trial -The only outcome of each trial is a head or a tail

Ombu Enterprises, LLC27

The Binomial Distribution

•The Bernoulli trial has two possible outcomes. -One outcome is “success" with probability p. -The other “failure" with probability q = 1 -p. •The binomial distribution is the probability of xsuccesses in ntrials ,,1,0,1Pr

Ombu Enterprises, LLC28

Excel Example

n = 20 , p = 0.1 What is the probability of exactly 0 successes, 1 success, etc. BINOMDIST(number_s,trials,probability_s,cumulative) sPr(s)

00.1216

10.2702

20.2852

30.1901

40.0898

50.0319

60.0089

70.0020

80.0004

90.0001

100.0000

110.0000

120.0000

200.0000

0.00000.05000.10000.15000.20000.25000.3000

01234567891011121314151617181920

Pr(s) s

Binomial Distribution

n=20, p=0.1

Ombu Enterprises, LLC29

Counting and

Classifying Records

Ombu Enterprises, LLC30

Records

•An auditor examines a certain number of records -Could be a judgment sample -Could be a statistical sample -a conformance test

•Typically, the audited process generates records at specific points as described in the procedure or process flow.

•Example: The record uses a form on one sheet of paper with 10 fields to complete.quotesdbs_dbs10.pdfusesText_16
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