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
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