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Internal Auditor Training
Isocert Solutions 2014 © Internal Audit Training In this training course we will discuss the history of Quality Systems, the difference between Quality Control and Quality Assurance, the different types of audits, Auditor traits and the planning, conducting and finalizing of Internal audits. Rev B 2
Who Is Responsible? This is a story about four people named EVERYBODY, SOMEBODY, ANYBODY and NOBODY. Isocert Solutions 2014 © Everybody Somebody Anybody Nobody Rev B 3
Who Is Responsible? O QUALITY was an important job to be done and EVERYBODY was sure SOMEBODY would do it. O ANYBODY could have done it, but NOBODY did it. Isocert Solutions 2014 © Rev B 4
Who Is Responsible? O SOMEBODY got angry about that because it was EVERYBODY’S job. O EVERYBODY thought ANYBODY could do it but NOBODY realized that EVERYBODY wouldn’t do it. O Moral to this story? EVERYBODY is responsible for Quality! Isocert Solutions 2014 © Rev B 5
Evolution of Quality Systems O Pryor to the Industrial Revolution products were produced by individual craftsmanship, these were: O Simple Products O One person or family organizations O Apprenticeship O Job security O No independent inspection Isocert Solutions 2014 © Rev B 6
Evolution of Quality Systems O Changes that took place as a result of the Industrial Revolution O Specialization/production lines are introduced O Training is reduced O Personal pride/ownership of product reduced O Interchangeability of parts O Independent inspection is introduced Isocert Solutions 2014 © Rev B 7
Evolution of Quality Systems Technology Era Part I O Increased complexity is required O Greater accuracy is needed O Nuclear Navy O Manned Space Program O Independent technical reviews come into use O More independent inspection is required O Documentation becomes part of the work environment O Quality Assurance concept is introduced Isocert Solutions 2014 © Rev B 8
Evolution of Quality Systems Technology Era Part II Even greater complexity is required Public Safety concerns Environmental concerns Space Shuttle Commercial nuclear products ISO:9000 is introduced to create consistency between nations Isocert Solutions 2014 © Rev B 9
Evolution of Quality Systems Information Technology Era Part I O Personal computers are common at work and at home O Global competition O Need to assess international suppliers to a common standard Isocert Solutions 2014 © Rev B 10
Evolution of Quality Systems Information Technology Era Part II O Education and training needs for today O Need to reduce costs O Information Highway O Internet and Intranet Isocert Solutions 2014 © Rev B 11
Quality Control The operational requirements that are used to control product quality Isocert Solutions 2014 © Provides the techniques and tools to measure products and services. Can be the inspection stage to determine if a product meets requirements May employ statistical techniques like a sample plan or inspection gates Can identify trends in addition to defective product Quality Control is Reactive- happens after the event Rev B 12
Quality Assurance All the planned systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements. O Examines processes, systems and people O Involves sales, design, purchasing, product realization and service O Minimizes the risk of quality problems by focusing on prevention O Is Proactive –establishes quality processes O Quality Control is the measurement aspect of Quality Assurance Isocert Solutions 2014 © Rev B 13
Isocert Solutions 2014 © Rev B What is a Quality Management System? O A Business System O Organizational Structure O Responsibilities O Documented Information O Processes O Resources for Implementation 14
Isocert Solutions 2014 © Rev B What is an Audit? O Audit: Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent which audit criteria are fulfilled. O ISO9000:2001 Quality Management Systems- Fundamentals and Vocabulary 15
Isocert Solutions 2014 © Rev B The Auditor Verifies O The system operates according to the planned methods O ISO9001:2008 O Company Quality Manual O Documented Information O Procedures and instructions 16
Rev B Isocert Solutions 2014 © The Auditor Verifies O The System is effective O Quality costs O Customer returns O Increased customer satisfaction O Decreased customer complaints 17
Kinds of Audits O System Audit O Does the documented quality system meet the requirements of the relevant quality standard? O Compliance O Is the documented quality system being complied with by the organizations staff? Isocert Solutions 2014 © Rev B 18
System Audit O Review of the Quality Manual, procedures and work instructions to the applicable ISO:9001 Standard to determine adequacy O Can be performed without visiting the actual point of operation in the quality system Isocert Solutions 2014 © Rev B 19
Compliance Audit O Is there a difference between what is documented and what is practiced? O The audit is based on a sample of activity O Persons performing the job are interviewed O Objective evidence is obtained to support auditor conclusions O Audit is performed by someone independent of the process Isocert Solutions 2014 © Rev B 20
Isocert Solutions 2014 © Rev B 21 Audit Groups O First party audits O Internal audits O Second party audits O Consultant, supplier or customer O Third party audits O Registrar, regulator
Isocert Solutions 2014 © Rev B 22 Auditor Qualities O The primary role of the auditor is to obtain information. To get information, the auditor must be able to ask the right question in a manner that encourages the flow of information O Style and sound of speech O Facial expression O Listening O Body language
Isocert Solutions 2014 © Rev B 23 Traits of an effective Auditor O Stand up for your own rights O Not violating the rights of others O Expressing your needs, wants, views and feelings in appropriate ways O Being honest and direct O Work towards satisfying needs and wants of all parties
Rev B Isocert Solutions 2014 ©24 Traits and to avoid to be an effective Auditor O Interpersonal behavior is an important consideration for an auditor: O Things to avoid O Passive O Failing to stand up for your rights as an auditor O Avoiding conflict to please or placate others
Isocert Solutions 2014 © Rev B 25 Traits to avoid to be an effective Auditor O Aggressive O Standing up for your own rights by violating the rights of others O Expressing your needs, wants, views, and feelings inappropriately O Ignoring, disregarding, or discounting needs, wants, views and feelings of others O The goal being to win, even if it is at the cost of others
Listening Isocert Solutions 2014 © Rev B 26 “The reason that we have 2 ears and one mouth is that we may listen more and talk less.” Greek philosopher, Zeno We listen at 125-250 words per minute, but think at 1000-3000 words per minute.
Listening Tips Rev B Isocert Solutions 2014 ©27 O Practice active listening O Give your full attention to the speaker O Let the speaker finish before you respond O Listen for main ideas O Ask questions O Give appropriate feedback, verbally, facially or body language
Isocert Solutions 2014 © Rev B 28 O Avoid sounding like an interrogator O Remain calm, objective and friendly O Remember 75% of auditing is listening O Avoid nitpicking O Include positive points O Give the individual the benefit of the doubt when necessary The auditor must take care to:
Isocert Solutions 2014 © Rev B 29 Style and Sound of speech O How you say something is often more important than what you say. O Voice quality has to do with voice inflection, cadence, tone, syllabic stress and pother characteristics which convey mood, emotion, and tonal insinuations. Tone is an art.
Style and Sound of Speech Rev B Isocert Solutions 2014 ©30 O Two sentences with exactly the same words, can have entirely different multiple meanings depending on voice and quality. For example: “ Congress has reduced the budget again this year”
Isocert Solutions 2014 © Rev B 31 Facial Expression O Facial expression is an important form of non verbal communication. Expressions convey the mood and current emotional state of the speaker. Expressions can communicate all kinds of emotions.
Importance of body language Isocert Solutions 2014 © Rev B 32 O Up to 93 % of communication is non-verbal: Tone of voice, eye movement, posture, hand gestures, facial expressions and more. O Body language usually prevails over words. O If Personal space is invaded it can cause an individual to feel uncomfortable or threatened.
Body language Rev B Isocert Solutions 2014 ©33 O Gestures communicate without the use of any speech. Touching can be friendly or it can be aggressive. The way a person stands reflects their level of confidence and comfort level. O Avoid shifting eyes and head quickly during conversation when someone asks you a question. Look directly at the person with a sense of confidence but not overbearing or threatening in nature.
Isocert Solutions 2014 © Rev B 34 Auditors O Should O Be punctual O Adhere to agreed upon program O Observe instructions O Avoid arguments O Respect confidentiality O Audit the process, not the person
Isocert Solutions 2014 © Rev B 35 Auditors Audit to O Quality Manual O Applicable Quality Standard O Quality system procedures and work instructions O Processes
Isocert Solutions 2014 © Rev B 36 Never use: O Misleading Questions O Trick Questions O Ambiguous questions O Multiple questions
Isocert Solutions 2014 © Rev B 37 Always O Rephrase a question if necessary O Be sure your questions are clear O Avoid giving the answer on your question O Be sure you only include one question at a time
Open ended Questions O Example: what is the process for________? O The open ended question is a good way to start an audit off. It can give the auditee a chance to explain what happens and puts the person at ease. You want to start off with an open question even if you are familiar with the operation. Isocert Solutions 2014 © Rev B 38
Open ended Questions O Be careful that open ended questions do not become monologues. Be polite but firm. O Redirect the conversation when you enter the time wasting zone. O Example: Could we go back to something you mentioned earlier? Isocert Solutions 2014 © Rev B 39
Probing O Follow-up type question O Designed to gain a greater depth of knowledge on a subject O Key communication skill for the auditor. O Example: Could I see the process? Could you explain in more detail? May I see the records? Isocert Solutions 2014 © Rev B 40
Closed O Used to establish specific facts O Normally receives a yes/no type answer O Not used too often O Example: Do you have a procedure for that? O Do you have a calibration record? O May I see the record? Isocert Solutions 2014 © Rev B 41
Isocert Solutions 2014 © Rev B 42 Typical Interview O Identify who you want to talk to O Introduce yourself O Explain what you are there for O Ask Individual to explain process O Ask Questions (checklist) O Check facts and record findings O When finished thank individual
Isocert Solutions 2014 © Rev B 43 Steps to an Audit O Schedule of audits is made O Assign Auditors to individual audits O Plan Audits O Hold opening meeting O Conduct Audit O Document results O Hold Closing meeting O Perform and verify corrective action
Isocert Solutions 2014 © INTERNAL AUDIT PROCESS FLOW CHART Rev B 44
Isocert Solutions 2014 © Rev B 45 Audit Schedule O Steps in preparing the audit schedule O Assure auditors are trained O Schedule training if necessary O List of audits to be performed O Assign auditors O Obtain agreement on schedule O Publish schedule O Click here to open AuditSchedule1.xlsxAuditSchedule1.xlsx
Isocert Solutions 2014 © Rev B 46 Planning The Audit O Planning is important to assure all the elements are covered and sufficient time is allotted for the audit. The Audit Plan identifies: O Scope-Requirements O Activities to be audited O Timing O Auditors O Checklists/procedures
Isocert Solutions 2014 © Rev B 47 Audit Notification O Auditee should be given notification: O Email O Phone O In person
Isocert Solutions 2014 © Rev B 48 Workshop Preparing the audit plan O Prepare an audit plan for an audit of ISO9001:2008 clause 8.3: O “The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities shall be defined in a documented procedure” O Use the sample planning checklist on page 50
O Where applicable the organization shall dealing with nonconforming product by one or more of the following ways: O By taking action to eliminate the detected nonconformity O By authorizing tis use, release or acceptance under concession by relevant authority and, where applicable by the customer O By taking action to preclude its original intended use or application Rev B Isocert Solutions 2014 ©49 Preparing the Audit Plan
Isocert Solutions 2014 © Rev B 50 Why might I need a checklist? O Supplements auditors memory O Lists points to be checked O Assures complete coverage of an area O Provides a basis to reconstruct the audit O Provides consistency O Improved auditor efficiency O Helps auditor get “back on track” if necessary O Click here to open planning checklist Audit Form.dotxAudit Form.dotx
Isocert Solutions 2014 © Rev B 51 Examples to include in an audit checklist O Include paragraph and clause from ISO 9001 and procedure O Reference forms or other documents you may want to review O Previous audit findings O Note tools and equipment O Provide space to take notes during the audit O Ask both specific and general questions
Isocert Solutions 2014 © Rev B 52 Question Examples O General question O Do you have a calibration procedure? O Ask to see the procedure O Yes would mean conformity no would mean nonconformity O Specific question O Do you have a calibration record for this tool? O Ask to see the calibration record O Yes would mean conformity no would mean nonconformity
Isocert Solutions 2014 © Rev B 53 Workshop Prepare an audit plan O ISO9001 clause to be audited: O 8.3 Control of nonconforming product O example: Quality Procedure 4 rev b
Nonconforming material process O Nonconforming Material O During the product realization or testing process, if material fails to meet its intended requirements, it is segregated or suitably identified to preclude unintended use. The nonconforming material is documented on the nonconformance form and a disposition decision is made. O Scrap O Rework O Use as is O If the disposition is rework or use as is, a deviation/waiver request is forwarded to the customer, if required and work will resume upon reply from the customer. O Nonconforming material and/or process data is collected via the nonconformance form and evaluated for trends with the goal of preventing future like situations and implementing improvement processes. Rev B Isocert Solutions 2014 ©54
Isocert Solutions 2014 © Rev B 55 Opening Meeting O Meet with responsible area management to: O Establish rapport O Review purpose of the audit O Review scope of the audit O Identify escorts O Identify personnel to be interviewed O Answer questions
O Using your audit plan, conduct an opening meeting. Isocert Solutions 2014 © Rev B 56 Workshop Opening Meeting
Audit Preparation Isocert Solutions 2014 © Rev B 57 O Have your checklist on a clipboard or notebook O Have writing implements handy O Refer to your checklist to assure you cover all points as planned O Take time to make notes as you conduct the audit
Interviewing Personnel Isocert Solutions 2014 © Rev B 58 O Establish rapport with auditee O Let the auditee know you will be taking notes O Determine how the auditee interprets documented requirements O Ask checklist questions O Ask to see documents, forms approvals and signatures
Sample Selection Isocert Solutions 2014 © Rev B 59 O Request typical documents for the work area O Examples: purchase orders, design documents, inspection records, calibration records O Select your own samples and files when possible O Record results, making copies as necessary and allowed
Workshop: Conducting an interview O Using your checklist, conduct an interview of an assigned team member O Practice recording notes and collecting objective evidence. Isocert Solutions 2014 © Rev B 60 Workshop Conducting an interview
Documenting Compliance/Noncompliance Isocert Solutions 2014 © For each checklist item: Notation for each point checked Positive entry – compliance Negative entry - noncompliance or finding (CAR) Objective evidence Documents Records Products Processes Equipment Details/Notes Pertinent auditor actions Description of conformity or nonconformity Precise location of evidence Rev B 61
Work Shop Preparing the Audit Report Isocert Solutions 2014 © Rev B 62 O Refer to your audit checklist and notes and objective evidence O Complete the audit report using an the audit Planning Checklist provided
Isocert Solutions 2014 ©. Rev B 63 Holding the Closing Meeting O Preparation Have the completed Audit Report ready for review & signature Sign and date as the auditor The meeting should be short Internal closing meeting may be very informal
The Closing Meeting Rev B Isocert Solutions 2014 ©64 O Presentation Thank the participants Summarized the good points Present Findings Cover any observations Review nonconformance's O Concluding Meeting Ask for questions Get signatures and dates from attendees on the Audit Report. Forward the original audit report to the Audit Coordinator
Isocert Solutions 2014 © Rev B 65 Workshop Closing Meeting O Prepare your audit report O Conduct closing meeting
Work Shop Creating the CAR O From your audit report, write up at least one corrective action request. O Click here to open Corrective Action Request (CAR) O car form.docx car form.docx Isocert Solutions 2014 © Rev B 66
Audit Records O Audit Schedule O Audit Plan O Audit Checklists O Audit Report O Corrective Action Report O These are now quality records and need to be maintained accordingly Isocert Solutions 2014 © Rev B 67
Review O In this training course we have addressed: O Responsibility for Quality O Evolution of Quality systems O Quality control vs Quality assurance O Types of audits O Effective auditor traits O Things to avoid O Planning, conducting and concluding an audit Rev B Isocert Solutions 2014 ©68
Record of training O Congratulations! O You have now completed training to become a Quality System Internal Auditor O It is recommended that a record of completion of this training be maintained. O On the following of slide in this presentation you will find a Certificate of Completion that can be completed by a Management representative Rev B Isocert Solutions 2014 ©69
Rev B Isocert Solutions 2014 ©70 CERTIFICATE OF COMPLETION AWARDED TO [ ENTER NAME HERE] For Quality Management System Internal Auditor Training Awarded this ___ day of __________, 20__ Isocert Solutions LLC
O For more information visit our website Isocertsolutions.com O We are a full service provider of products and services to support Quality Assurance in any industry. Rev B Isocert Solutions 2014 ©71
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