GCE_Quality Management System Auditor & Lead Auditor

QUALITY MANAGEMENT SYSTEM AUDITOR & LEAD AUDITOR

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AUDIT BASICS

Definitions - Audit, Audit Criteria, Audit Evidences Type of Audits Purposes and Benefits of Auditing Audit Participants Independence and Objectivity

Audit

Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

Audit Criteria

Set of policies, procedures, or requirements used as a reference against which the audit evidence2 is compared.

Audit Evidence

Records, statements of facts, or other information which are relevant to the audit criteria and verifiable.

AUDIT BASICS

Definitions - Audit, Audit Criteria, Audit Evidences Type of Audits Purposes and Benefits of Auditing Audit Participants Independence and Objectivity

Types of Audits

Product Audit

Process Audit

System Audit

First Party Audit

Second Party Audit

Third Party Audit

PRODUCT AUDIT

Product Audit

Process Audit

System Audit

Assessment of “fitness for use” Products meet the design requirements

Process Audit

One specific process, activity, or function To compare the actual process with the documented requirements of the process.

Product Audit

Process Audit

Inputs

Output

Process

STEP 1

STEP 3

STEP 2

System Audit

System Audit

Product Audit

A comprehensive audit of multiple processes

Process Audit

Includes the interaction between processes

System Audit

PRODUCT, PROCESS, AND SYSTEM AUDIT

System

Process

Product

PRODUCT, PROCESS, AND SYSTEM AUDIT

SYSTEM

PROCESS

PRODUCT

First Party Audit

Suppliers

Customers

Organization

Internal audits Performed within an organization Auditors have no vested interest in the area being audited

Second Party Audit

Suppliers

Customers

Organization

Performed by Customers on suppliers​

Before or after awarding a contract​

Third Party Audit

Third Party

Suppliers

Customers

Organization

Performed by an audit organization independent of the customer-supplier relationship Free from any conflict of interest

FIRST, SECOND, AND THIRD PARTY AUDITS

First Party Second Party Third Party By a third party appointed by client By Client Internal

INTERNAL AND EXTERNAL AUDITS

Internal Audit

External Audit

SECOND PARTY AUDIT

Suppliers

Customers

Organization

Suppliers

Customers

Organization

THIRD PARTY AUDIT

Third Party

FIRST PARTY AUDIT

Suppliers

Customers

Organization

CERTIFICATION AUDIT

The most common certification audit (quality) is ISO 9001 ISO does not conduct these audits Certification audits are conducted by Certification Bodies (CB)

CERTIFICATION AUDIT Certification Bodies (CB) are accredited by a member of the International Accreditation Forum (IAF) Member. Many countries have formed accreditation bodies to authorize ("accredit") the certification bodies.

Organization

ISO 9001

A typical ISO 9001 certificate will have the logo of the Certification Body, the Accreditation Body and the International Accreditation Forum (IAF) logo Certification Audit

AUDIT BASICS

Definitions - Audit, Audit Criteria, Audit Evidences Type of Audits Purposes and Benefits of Auditing Audit Participants Independence and Objectivity

Purposes and Benefits of Auditing

COMPLIANCE

IMPROVEMENT

Identifies opportunities for improvement Reduce rework, rejections Reduced cost Increase sales Find the problems before the customer does Corrective actions are effective

Ensures compliance to the industry, and statutory/regulatory requirements Avoid lawsuits Maintain market standing and/or reputation Compliance to procedures and internal work processes Provides confidence to stakeholders

AUDIT BASICS

Definitions - Audit, Audit Criteria, Audit Evidences Type of Audits Purposes and Benefits of Auditing Audit Participants Independence and Objectivity

Client – organization or person requesting an audit. Auditor – A person who conducts an audit Auditee – organization or individual being audited Audit Participants

Client - Responsibilities Initiates audit

Determines audit purpose and scope

Provide resources

Receives the audit report

Determine the report distribution

Understand the purpose, scope, and audit criteria Plans the audit Perform the audit Collect audit evidences Analyze audit evidences Reports the audit Follows up the action on audit findings Auditor - Responsibilities

Balance the strengths and weaknesses of team members LEAD AUDITOR - RESPONSIBILITIES

Manage the audit process

Represent the audit team

Lead the audit team

Prepare and complete the audit report

AUDITEE - RESPONSIBILITIES

Inform the staff

Provide resources (interview room, communications, and clerical support)

Assign a guide for the audit team

Show objective evidence

Co-operate

Determine and initiate corrective actions

AUDIT PARTICIPANTS - 2 Technical Expert – a person who provides specific knowledge or expertise to the audit team Observer – a person who accompanies the audit team but does not audit

Guide – a person appointed by the auditee to assist the audit team

AUDIT BASICS

Definitions - Audit, Audit Criteria, Audit Evidences Type of Audits Purposes and Benefits of Auditing Audit Participants Independence and Objectivity

INDEPENDENCE Auditors are independent when they render impartial and unbiased judgment in the conduct of an audit Conflict of interest is a situation in which an internal auditor has a competing professional or personal interest Audit independence is essentially a state of mind. Internal auditors can not be physically independent of the organization they are working for, but they can always stay objective

Objectivity

Objectivity is a mental attitude that auditors should maintain while performing engagements The auditor should have an impartial, unbiased attitude and avoid conflict of interest situations auditors are not to accept fees, gifts, or entertainment that may create the appearance that the auditor's objectivity has been impaired

AUDIT PLANING

Overview of Auditing Process​ Audit Purpose, Scope and Criteria​ Audit Program and Plan​ Auditor Selection​ Auditing Strategies​ Activities Prior to the Site Visit​

Planning and Preparation Opening Meeting Audit Interviews Closing Meeting Reporting Follow-up and Closure Overview of Auditing Process

AUDIT PLANING

Overview of Auditing Process​ Audit Purpose, Scope and Criteria​ Audit Program and Plan​ Auditor Selection​ Auditing Strategies​ Activities Prior to the Site Visit​

Audit Purpose, Scope, and Criteria Audit Purpose What is to be accomplished by the audit? Defined by the audit client Audit Scope

Extent and boundaries of the audit, Satisfies the purpose of the audit Audit Criteria Reference against which conformity is determined

Audit Purpose Two main purposes of an audit are: Compliance Improvement Examples of audit purpose/ objective: Conformity of the management system

Meeting relevant statutory and regulatory requirements and other requirements to which the organization is committed Effectiveness of the management system in meeting its intended results Identifying opportunities for improvement

Audit Scope Extent and boundaries of an audit Clearly defining the audit scope is important in determining the budget, human resources, and time required for the audit The scope defines what is included and what is excluded: Location (Plant A only) Functions (Materials Management) Processes / Activities (From receiving a material requisition to receipt of material)

AUDIT CRITERIA Set of policies, procedures, or requirements used as a reference against which audit evidences are compared

Examples of Audit Criteria include: National or international standards Industry codes and standards Laws and regulations Contracts Purchase orders Customer specifications

AUDIT CRITERIA

ISO 9000:2015 Quality management systems - Fundamentals and vocabulary

ISO 9001:2015 Quality management systems Requirements

ISO 9004:2018 Quality management - Quality of an organization - Guidance to achieve sustained success

ISO 19011:2018 Guidelines for auditing management systems

Audit Criteria – Management System Standards ISO 9001 – Quality management system ISO 14001 – Environmental management system ISO 22000 - Food safety management systems ISO 22301 - Business continuity management systems ISO 45001 - Occupational health and safety management systems ISO 50001 - Energy management systems

Audit Criteria – Industry Specific Management System Standards ISO 13485 – Medical devices ISO 17025 - Competence of testing and calibration laboratories ISO 29001 - Petroleum, petrochemical, and natural gas industries TL 9000 – Telecommunications AS 9100 – Aerospace IATF 16949 - Automotive

AUDIT PLANING

Overview of Auditing Process​ Audit Purpose, Scope and Criteria​ Audit Program and Plan​ Auditor Selection​ Auditing Strategies​ Activities Prior to the Site Visit​

AUDIT PROGRAM Audits are planned and documented Formal and systematic Are never informal An audit program shall be planned, taking into consideration the status of the processes importance of the processes the results of previous audits Frequency also depends on the Criticality of the product or service

AUDIT PLAN The Lead Auditor prepares the plan Communicates the plan to: Client Auditee Other Stakeholders

AUDIT PLAN Audit planning should address or reference the following: Audit objectives Audit scope … functions, and processes to be audited Audit criteria … ISO 9001:2015 Locations, dates, expected time and duration of the audit Audit team members

Audit Plan Formal audit notification required for second-party or third-party audit Generally, advance notification is provided Communicate the plan to: Client Auditee Other stakeholders as applicable

AUDIT PLANING

Overview of Auditing Process​ Audit Purpose, Scope and Criteria​ Audit Program and Plan​ Auditor Selection​ Auditing Strategies​ Activities Prior to the Site Visit​

Audit Team Selection The number and composition of the auditor team depend upon: Objective, Scope, and Audit Criteria Competence of team members Teamwork, and the ability to interact effectively with the auditee statutory, regulatory, contractual and accreditation/certification requirements To be continued …

The number and composition of the auditor team depend upon: Language / cultural issues Location of audit Cost consideration Time available Audit Team Selection

AUDITOR COMPETENCIES Factors to consider:

Auditing Knowledge

Audit principles, procedures, and methods Management system

Technical Knowledge

Contractual requirements Codes and standards Discipline / Sector-specific

Personal Behavior

Auditor Competencies (Positive) Ethical Open-minded Diplomatic Tenacious (persistent) Decisive Self-reliant Culturally sensitive Collaborative

AUDITOR COMPETENCIES (NEGATIVE) Argumentative

Opinionated

Aggressive

Inconsiderate

Inflexibility

Lazy

Impractical

“Know-it-all”

Indecisive

WHAT GOOD AUDITORS DO? Plan and organize

Time management

Prioritize and focus on significant issues

Interview, listen, observe and review documents

Communicate effectively

Understand the risks associated

AUDIT PLANING

Overview of Auditing Process​ Audit Purpose, Scope and Criteria​ Audit Program and Plan​ Auditor Selection​ Auditing Strategies​ Activities Prior to the Site Visit​

Auditing Strategies

Trace forward

Trace backward

Random selection AKA Discovery

Auditing Strategies – Trace Forward

An examination from beginning to the end

Beneficial to get the whole picture from the start to finish.

Auditing Strategies – Trace Backward

Beginning at the end and working back through the process

Understanding of end objective is attained right away

All product records exist

Auditing Strategies – Random Selection​ AKA Discovery

Advantage: Where time and personnel are limited Most frequently used Use of flowchart to identify important steps Flexible and saves time

Disadvantage:

Additional note-taking Difficulty in understanding the process flow Experienced auditor required

HORIZONTAL VS. VERTICAL AUDIT Element Audit (Horizontal) Department Audit (Vertical)

Several system elements are audited in a single department (e.g. design department)

Selected elements are audited across multiple departments (e.g. training) To satisfy elements on checklist several departments audited

Saves times (+)

Judges company on management of one or selected departments (-)

The auditor should be very familiar with the requirements

Horizontal vs. Vertical Audit

AUDIT PLANING

Overview of Auditing Process​ Audit Purpose, Scope and Criteria​ Audit Program and Plan​ Auditor Selection​ Auditing Strategies​ Activities Prior to the Site Visit​

ACTIVITIES PRIOR TO THE SITE VISIT

Notify the auditee

Review auditee documents

Arrange audit logistics

Prepare the audit checklist

Advance/formal notice to the auditee NOTIFY THE AUDITEE

Notification to auditee Quality Manager and the top management

NOTIFY THE AUDITEE

Contents of audit notification:

Audit objective, scope and criteria Names of the audit team members and the team leader Official contacts of lead auditor Time and location of the opening meeting Identification of areas of special concern Tentative audit schedule (to be reconfirmed in the opening meeting) Documents to be submitted prior to the audit for review

ACTIVITIES PRIOR TO THE SITE VISIT

Notify the auditee

Review auditee documents

Arrange audit logistics

Prepare the audit checklist

Typical Quality System Documents

Quality Manual

Procedures

Work Instructions

Forms

QUALITY MANUAL

ISO9001:2015 does not require a Quality Manual

Manual based on ISO 9001 standard vs manual based on processes.

PROCEDURES

Procedures provide a high-level overview of the process

Procedures do not include the “detailed how” component of the process

Procedures are generally multi- discipline

WORK INSTRUCTIONS Step by step instructions, how the work is done

FORMS To record the compliance The terms documents and records have now been changed to “documented information” in ISO 9001:2015

Product specification Drawings Inspection and Test Plan Inspection and Test Reports Results of prior reviews and audits OTHER TYPES OF DOCUMENTS

Pre-audit Information

Most organizations have electronic copies of documentation and the information can be shared electronically. Auditee might not want to share a copy of some confidential documents. At this stage, the audit team needs limited information for the preparation purpose only.

REVIEW AUDITEE DOCUMENTS

Review documents related to the auditee organization

Contract, Specifications, Quality Manual, Procedures, Guidelines Organization Charts Codes and Regulations etc.

Previous audit reports/programs

REVIEW AUDITEE DOCUMENTS

Advantages of in-office review:

Gain a good understanding of the auditee

Enable the team to prepare relevant questions to the auditee during the opening meeting. Help the team to understand well the criteria (what is to be done; by whom and when). Saves the audit investigation time

REVIEW AUDITEE DOCUMENTS

Identifying areas for audit emphasis (risk area) These include: Areas identified/documented in the Risk Register. Areas of the high possibility of mismanagement Areas of large volumes of transactions Areas of concerns identified by Client Major weakness/deficiencies identified in the prior audits

ACTIVITIES PRIOR TO THE SITE VISIT Notify the auditee Review auditee documents Arrange audit logistics Prepare the audit checklist

ARRANGE FOR AUDIT LOGISTICS

Travel and accommodation Safety and security considerations Personal Protective Equipment (PPE) Location and/or Camera Permit Need for a Guide Translators Facilities Working area, conference room, internet, printer, tea/coffee and working lunch

ACTIVITIES PRIOR TO THE SITE VISIT

Notify the auditee

Review auditee documents

Arrange audit logistics

Prepare the audit checklist

AUDIT CHECKLIST - PURPOSE Memory tool

To ensure that all areas have been covered

Help in time management

Helps in note-taking

The checklists should be a good servant, never the master, of the auditor.

Evidence of audit effectiveness

Audit Checklist

Developed by Lead auditor or auditor

Based on audit purpose and scope

Include open-ended questions

Should have space to record response

Send it to auditee prior to the audit, along with the audit notification

AUDIT CHECKLIST - GENERIC VS SPECIFIC

Generic checklists Supplement with specific items

Specific Checklists Prepared for a specific use

AUDIT CHECKLIST – SCORING VS. NON-SCORING

Scoring checklists:

Used for comparison purpose The score may become the goal, and bias in marking Non-scoring checklists: Good for continuous improvement and are flexible

AUDIT CHECKLIST – ADVANTAGES

Promotes planning for the audit

Thorough coverage of the scope

Time management during the audit

Consistent audit approach

Serves as a memory aid

Objective evidence that the audit was performed

Information base for future audits

AUDIT CHECKLIST – DISADVANTAGES

Questionnaires narrow the vision

Questionnaires may obstruct communication

Too strict following of the checklist may result in the omission of important audit trails

Generic checklists may not add any value

AUDIT CONDUCTING

Opening Meeting

Interviews and Data Collection

Summarizing the Audit Findings

Closing Meeting

AUDIT OPENING MEETING PURPOSE Introduce the audit team and their roles; Confirm the agreement of all participants (e.g. auditee, audit team) to the audit plan;

Ensure that all planned audit activities can be performed

Audit Opening Meeting Participants Auditee senior management Quality Manager Audit guides All audit team participates Lead Auditor chairs the meeting

Don’t forget to keep a record of meeting participants

Confirmation of audit objectives, scope, criteria, and plan, including arrangements with the auditee, language use, resource availability, confidentiality, access, health and safety, and site-related considerations. Also, agreement on reporting methods, termination conditions, and addressing any questions or clarifications. Audit Opening Meeting Agenda

AUDIT CONDUCTING

Opening Meeting

Interviews and Data Collection

Summarizing the Audit Findings

Closing Meeting

Interviews and Data Collection​ Interviewing

Observation / Measurement

Document and Record review

Establish suitable climate Put auditee at ease Ask questions in a conversational manner Questions should: Yield the relevant information Should not suggest answers Should not contain emotional words Interviewing Techniques

Three Types of Questions: Open-ended questions Closed-ended questions Clarifying questions

Open-ended Questions Start with … What? Why? Where? Who? When? How? Advantage: Yield informative answer Limitation: May lead to conversation get side-tracked!

One way to keep the audit on track is: ….. Show me!

Close -ended Questions

Closed-ended questions Answer: Yes/No

Open questions Answer: a few words and explanation Intended to yield very specific information

Disadvantages: Do not bring much information If used too often may create the impression of cross-examination

Clarifying Questions

Intended to clarify, retrieve full information and prevent misunderstanding

Disadvantages:

If used too often may create impression that you were not listening

Are time-consuming

If you are not prepared to listen in full don’t ask them

Interviewing Tips

Generally use open-ended questions and sparingly closed- ended questions

Focus on the process and not the individual

Take proper notes (drawing number/rev. number, part number, record reference)

Share potential findings before leaving the interview

Interviews and Data Collection​ Interviewing

Observation / Measurement

Document and Record review

Observations

Typical observations include: What is it used for?

Does this need to be calibrated? Was it calibrated? Is there a record? What is the reading?

Is the reading within the acceptable range? What if this is not in the acceptable range?

Identification and traceability? Storage location & conditions?

Observations

Make sure you are not obstructing the work

Be aware of safety requirements

Consider taking pictures only if it is permitted and agreed with the auditee organization

Don’t forget to keep the record of observations (part number, location, machine number etc.)

Interviews and Data Collection​ Interviewing

Observation / Measurement

Document and Record Review

Document / Record Review Ask for documents and records during interviews and observations

Consider random sampling when reviewing documents and records

Documented information can be in any format and media and from any source

Don’t forget to keep a record of observations (part number, location, machine number etc.)

Document / Record Review Sampling You do not have time to check everything. Select representative samples Cover the relevant work period when selecting documents/records

Is it available and suitable for use, where and when it is needed? Is it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)? Is it preserved to ensure legibility? Is change control (revision) in place? Is it protected from unintended alterations? Documented Information (ISO 9001:2015)

RELIABILITY OF OBJECTIVE EVIDENCES - RULES OF THUMB

Documentary evidence is usually better than verbal evidence. Audit evidence is more reliable when evidences obtained from different sources are consistent. (Corroboration) Evidences generated through the auditor's direct observation, inspection, and computation are usually better than evidence obtained indirectly.

AUDIT CONDUCTING

Opening Meeting

Interviews and Data Collection

Summarizing the Audit Findings

Closing Meeting

Notes Taking

Make your notes:

Comprehensive

Accurate

Precise

Legible

Notes Taking

Documents: Title and document number Revision number Issue Date Location where the document was seen

Part: Part description Identification number

Person: Name Title Department

Corroboration

To strengthen with other evidence, to make more certain

More important for data/information which could be questionable/doubtful

Confirming or verifying using multiple sources

AUDIT CONDUCTING

Opening Meeting

Interviews and Data Collection

Summarizing the Audit Findings

Closing Meeting

PRIOR TO AUDIT CLOSING MEETING

Audit team meets before the closing meeting to:

Confirm achievement of audit objective, coverage of audit scope, and fulfilment of audit criteria Review audit findings Agree on audit conclusions Prepare recommendations, if specified by audit plan Discuss audit follow-up

Audit Closing Meeting Purpose To present the audit findings and conclusions To ensure a clear understanding of the audit results Agree on the timeframe for corrective actions.

Auditee senior management

Quality Manager

People responsible for the areas/functions audited

Audit guides

All audit team participates

Lead Auditor chairs the meeting

Don’t forget to keep a record of meeting participants​

Audit Closing Meeting Agenda

Agenda includes:​

Audit purpose and scope​ Explain about sampling​

Method of reporting (grading)​ Presentation of audit findings​ The draft report and expected time of the release of the final report​ The expectation of action on audit findings​ Recommendations and opportunities for improvement (only if specified by audit objective)​ Assure confidentiality of information​ Any disagreement (resolve or else record)

Audit Reporting

Effective Audit Reporting

Non-Conformities Classification

Corrective and Preventive Actions

AUDIT REPORT

A formal audit report needs to be provided to the auditee.​ The audit report might need the approval of auditor management.​ The report should be sent timely, as agreed in the exit meeting.​ The distribution of the report is decided by the Client.​

AUDIT REPORT ELEMENTS

Auditee organization​ Purpose, scope and audit criteria​ Identification of the audit client​ Date, time and location of the audit​ Audit team members​ Opening and Closing meeting participants​ Personnel interviewed​ Reference of documents reviewed​

Area not covered (if any with justification)​ Audit findings, evidences and classification​ Audit conclusion including a statement on the degree to which the audit criteria have been fulfilled​ Any unresolved diverging opinions between the audit team and the auditee​ A statement that the audits by nature are a sampling exercise​

AUDIT REPORT ELEMENTS

The audit report may also include:

Obstacles observed during the audit which could reduce the audit reliability

Best practices observed

Action plan to resolve findings (if agreed during the audit)

Opportunities for improvement (if it is a part of the audit objective)

AUDIT REPORT – AVOID THESE​

Acronyms​ Name of individual employees​ Nit-pick (trivial many)​ Emotional or argument statements​ Surprises​ Technical jargon or too complicated language​ Not including positive aspects​ Late report *

Audit Report – Timing Complete as soon as possible​ Problems with Formal Report procrastination​ The longer it is put off, the lesser interest in pursuing the corrective actions​ A signal to the auditee management that audit is not important as was initially believed​

Audit Reporting

Effective Audit Reporting

Non-Conformities Classification

Corrective and Preventive Actions

Nonconformities Classification Nonconformities and their supporting audit evidence should be recorded.​ Nonconformities could be graded depending on the level of risk.​

Typically third-party auditors classify them as the minor or major NCR (Non-conformance Report)*​ Nonconformities identified should be discussed with the audit team during team meetings.

Nonconformities Classification Impact (or Severity)

Nonconformities are classified as major or minor based on: Severity Frequency Level of Risk

Audit Reporting

Effective Audit Reporting

Non-Conformities Classification

Corrective and Preventive Actions

CORRECTIVE AND PREVENTIVE ACTIONS

Correction Action to eliminate a detected nonconformity

Corrective Action Action to eliminate the cause of a nonconformity and to prevent recurrence Preventive Action Action to eliminate the cause of a potential nonconformity or other potential undesirable situation

Correction

Action to eliminate a detected nonconformity

A correction can be made in advance of, in conjunction with or after a corrective action

A correction can be, for example, rework or regrade

Corrective Actions Action to eliminate the cause of a nonconformity and to prevent recurrence. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.

Corrective Actions

When a nonconformity is identified in the audit report, the auditee needs to take two actions:

Correction (remedial or containment actions)

Corrective Action (to prevent recurrence)

CORRECTIVE ACTIONS – KEY STEPS Identify the problem​ Contain the problem,​ Determine the causes of the problem,​ Propose solutions to eliminate them or prevent their recurrence​ Verify that the solutions are implemented​ Confirm their effectiveness.​

ISO 9001:2015 does not have requirements related to the Preventive Action PREVENTIVE ACTIONS

The concept of Preventive Actions is addressed using the “Risk-Based Thinking” concept

Audit Follow-up and Closure Audit Follow-up Audit Closure

Audit Follow-up and Closure The audit team identifies nonconformity.​ Auditee proposes Corrective Actions.​ The Client, the audit program manager or the lead auditor review the proposed Corrective Actions.​ The auditee complete the necessary actions​ The lead auditor verifies the completion and effectiveness of Corrective Actions. *​ Follow up on ineffective Corrective Actions​ Close the audit​

Audit Follow-up and Closure

Follow-up audit to verify the Corrective Action implementation and effectiveness. ​

Effectiveness of the Corrective Action ensures that the desired objectives are met

To save time and money, the verification could be done via:​

Document review​ Remote audit​ Combined with subsequent audit​

AUDIT FOLLOW-UP AND CLOSURE Why would the reviewer reject the Corrective Action Plan? Auditee does not understand the difference between the Correction and Corrective Action The root cause of the nonconformity is identified and addressed. The focus is only on symptoms Typical list of causes which are not acceptable: Human error The procedure ignored or not followed

When all agreed Corrective Actions have been completed and found to be effective, the audit can be closed Audit records to be retained as per procedure or applicable requirements AUDIT FOLLOW-UP AND CLOSURE

SAMPLING Why Sample?

Types of Sampling

Sampling Risk/Errors

WHY SAMPLING Because of the cost and time involved in studying the entire population.

Probability Samples Everyone in the population has an equal chance of being selected Non-Probability Samples Where the probability of selection can't be accurately determined. Sample may not be (generally isn’t) representative of the general population TYPES OF SAMPLING

TYPES OF SAMPLING

Simple Random Sampling TYPES OF SAMPLING

Systematic Random Sampling Select elements at regular intervals through that ordered list. Example: Checking every 6th piece produced by the machine.

STRATIFIED RANDOM SAMPLING

Used to ensure that sub-groups within a population are represented proportionally in the sample. Example: If 10 people are drawn to represent a country, 5 of them are male and 5 females to avoid the sex bias.

CLUSTER SAMPLING

Sometimes it is more cost-effective to select respondents in groups ('clusters').

Sampling is often clustered by geography, or by time periods.

Example: Survey all customers visiting particular stores on particular days.

CONVENIENCE SAMPLING

The researcher selects whom ever is convenient. The samples are being drawn from that part of the population which is close to hand Example: A researcher at the mall selects the first five people who walk by to get their opinion of a product.

Non probability sampling

JUDGMENTAL SAMPLING The researcher chooses the sample based on who they think would be appropriate for the study.

Example: Auditor selects a sample based on the concerns he/she had in the earlier audit

Non probability sampling

QUOTA SAMPLING A quota is established and auditor are free to choose any sample they wish as long as the quota is met. Example: 2% of the calibration records.

Non probability sampling

ACCEPTANCE SAMPLING STANDARDS

Attribute Sampling

You need to decide

Level (e.g. I, II, III, S1, S2, S3 or S4) AQL (Acceptable Quality Limit) – e.g. 1.5% Single, Double or Multiple Sampling Plan Reduced, Normal or Tightened inspection

ATTRIBUTE SAMPLING SAMPLING EXAMPLE EXAMPLE Lot size : 1,000, General inspection level II Acceptable Quality Limit(AQL): 1.5% Take 80 random samples: 1.Accept the lot if 3 or less are rejected. 2.Reject the lot if 4 or more rejected.

SAMPLING TERMS

Sampling Terms

THANK YOU

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