AUT03001ENGX v1.0(AD01) Mar 2017 Copyright © 2017 BSI. All rights reserved. 90 BSI Group (Thailand) Co., Ltd 127/29 Panjathani Tower, 24th Floor, Nonsee Road, Chongnonsee, Yannawa, Bangkok 10120, Thailand Tel : 0-2294 - 4889 - 92 Fax: 0-2294 – 4467 | www. bsigroup.com | [email protected]
AUT03001ENGX v1.0(AD01) Mar 2017 Copyright © 2017 BSI. All rights reserved. 91 BSI Group (Thailand) Co., Ltd 127/29 Panjathani Tower, 24th Floor, Nonsee Road, Chongnonsee, Yannawa, Bangkok 10120, Thailand Tel : 0-2294 - 4889 - 92 Fax: 0-2294 – 4467 | www. bsigroup.com | [email protected]
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 1 of 24 References This document contains typical activity solutions and additional information referred to during the course. Table of contents: Activity 1: Terms and definitions (auditing) ....................................................................... 2 An example audit process model...................................................................................... 3 Activity 2: Principles of auditing ....................................................................................... 4 Activity 3: Aligning clauses of 16949 to process activities ................................................... 4 Activity 4: Review Case Study and proposed audit plan ...................................................... 6 Activity 5: Work documents (checklists/turtle diagram) .................................................... 10 Activity 6: Question types.............................................................................................. 14 Activity 7 Pathfinder quiz ............................................................................................... 14 Activity 8: Internal audit................................................................................................ 14 Activity 9: Nonconformity findings .................................................................................. 15 Activity 10: Your closing meeting ................................................................................... 21 Audit report ................................................................................................................. 22 Activity 11: Audit follow-up ........................................................................................... 24 Activity 12: Reflection quiz ............................................................................................ 24
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 2 of 24 Activity 1: Terms and definitions (auditing) TERM DEFINITION 1 audit criteria D sets of policies, procedures, or requirements used as a reference against which audit evidence is compared 2 audit evidence F records, statements of fact or other information, which are relevant to the audit criteria and verifiable 3 audit findings G results of the evaluation of the collected audit evidence against audit criteria 4 auditee C organization being audited 5 auditor J person who conducts an audit 6 nonconformity I non-fulfillment of a requirement 7 audit team K one or more auditors conducting an audit, supported if needed by technical experts 8 audit programme A arrangements for a set of one or more audits planned for a specific timeframe and directed towards a specific purpose 9 audit plan H description of the activities and arrangements for an audit 10 audit scope B extent and boundaries of an audit 11 guide E person appointed by the auditee to assist the audit team
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 3 of 24 An example audit process model
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 4 of 24 Activity 2: Principles of auditing Integrity Foundation of professionalism Fair representation Obligation to report truthfully and accurately Due professional care Application of diligence and judgement in auditing Confidentiality Security of information Independence Basis for the impartiality of the audit and objectivity of the audit conclusions Evidence based Approach Rational method for reaching reliable and reproducible audit conclusions in a systematic audit process Activity 3: Aligning clauses of 16949 to process activities Your tutor will provide individual coaching and facilitation, as requested, to develop your knowledge in this area. Below are some examples to assist you: 1.2 Applicability Page 4 IATF clause 4.3.1 Determining the scope of the quality management system – supplemental 3. Context and risk/opportunity (extracts relevant supply chain management process)- Pg 5 ISO 9001 clause 4 Context of the organization 4. QMS policy (relevant supply chain management process) – Page 10 ISO 9001 Clause 5.2 Policy 5. Organization chart (Note) IATF Clause 5.1.1.3 Process owners 6. Customer focus (extracts relevant to the organization) – Page 12 ISO 9001 Clause 5.1.2 Customer Focus 7. Overview of organizations processes – Page 13 IATF Clause 7.5.1.1 Quality management system documentation
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 5 of 24 8. QMS objectives – Page 14 IATF Clause 6.2.2.1 Quality objectives and planning to achieve them (Also ISO 9001 Clause quality objectives and planning to achieve them) 9. Competencies – Page 14 IATF Clauses 7.2.1 Competence – supplemental and 7.2.2 Competence – on-the-job training 10. Documented information – Page 14 ISO Clause 7.5 Documented information, and IATF Clause 7.5.1.1 Quality management system documentation 11. Customer satisfaction – Page 15 ISO 9001 Clause 9.1.2 Customer satisfaction, and IATF Clause 9.1.2.1 Customer satisfaction – supplemental 12. Complaints, nonconformity and improvement – Page 15 ISO 9001 Clause 8.7 Control of nonconforming outputs, IATF Clauses 8.7.1.1 Customer authorization for concession, 8.7.1.2 Control of nonconforming product – customer specified process, 8.7.1.3 Control of suspect product, 8.7.1.4 Control of reworked product etc. (Also could be 8.7.1.4 – 8.7.17). IATF Clause 10.3.1 Continual improvement – supplemental Master document control form (extracts) – Page 16 IATF Clause 7.5.1.1 Quality management system documentation Supplier selection and approval – Page 17 IATF Clause 8.4.1.2 Supplier selection process Production Material Procurement – Page 18 IATF Clause 8.4.3.1 information for external providers – supplemental Receipt of Materials, Product or Processed Parts from Suppliers – Page 19 IATF Clause 8.4.2.1 Type and extent of control – supplemental PPAP Procedure – Page 21 IATF Clause 8.3.4.4 Production approval process Potential Failure Mode and Effects Analysis (FMEA) – Page 21 IATF Clause 8.3.5.2 Manufacturing process design output Control Plans - Page 22 IATF Clause 8.5.1.1 Control plan Measurement systems analysis – Page 22 IATF Clause 7.1.5.1.1 Measurement system analysis
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 6 of 24 Activity 4: Review Case Study and proposed audit plan Your tutor will provide individual coaching and facilitation, as requested, to develop your skills in this area of the audit. The following issues have been identified to help you: Audit briefing was in January, but audit not scheduled for august. Anything changed? No opening meeting has been planned; so there is no opportunity to confirm availability of auditees and to confirm the interviews planned. Will all the process owners be available? The overview of process planned for 1.5 hours, this should not take so long. This should only take 15 minutes, only included John Philips – should include all process owner(s)? Review of 3 suppliers is only allocated 15 minutes is this sufficient, and will they cover the Raw material providers, Components providers, Heat treatment providers? Only one supplier PPAP is to be reviewed, is this sufficient, also only 15 minutes allowed. There is insufficient time allocated Only 15 minutes allocated to review supplier performance data and escalation process Lunch break is 1.5 hours? Only 10 minutes allocated to: Review Management Review reporting/actions – is this sufficient time? Only 10 minutes to view and assess Job description v actual activity conducted – Bob Irvine – is this sufficient time? There is no time allocated to prepare audit conclusions prior to the closing meeting Have all areas been covered from the Audit Briefing document? This plan will not achieve the audit objectives
References A better worked example Process/procedure(s)/clauses audited: OML-P06 Supply chain management process Auditee(s)/process owner: J. Philips, Quality Engineer, GRI/Bob Irvine Auditor(s) You (Delegate) Report number: Aud-22-20xx Audit Start Time: 09:00 Audit Finish Time: 16:00 Date of audit: 22/8/XX Documentation to be reviewed during audit: List PF06-02 Approved Supplier List PF06-02 ll
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 7 of 24 PF06-01 Supplier Quality Assurance Questionnaire PF06-03 Purchase Order Supplier PPAP Supplier Performance Data Audit plan Time Activity THESE COLUMNS ARE FOR AUDITOR USE ONLY Evidence Notes/discussions Yes No N/A 08:30 Preparation for audit. Remind required people and confirm availability. 09:00 Opening meeting, confirm audit scope and conduct an overview of process/supporting procedures with Bob Irvine /John Philips Ensure scope is clear
References Time Activity These columns are for Auditor Use only Evidence Notes/findings Yes No N/A 09:30 Supplier selection approval and delegations. Review one of each: Raw material, components and heat treatment provider. Reference: 0063 Supplier Quality Assurance Questionnaire and Supplier List F06-02 Material and Sub-Contract Suppliers – John Philips Ensure supplier’s certificates are current and scope is correct. Reference: Process document OML-P06 10:30 Select one supplier and review purchase order for completeness: Description, revision level, customer specific requirements (if applicable) etc. –JohnPhilips Reference: Contract if necessary
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 8 of 24 John Philips 11:00 Review PPAP for selected supplier; verify customer sign off and completeness – Quality Engineer If applicable 11:30 Review receiving inspection data for supplier – Goods Receiving Inspector 12:00 Review supplier performance data; review action and escalation process for poorly performing providers – John Philips 12:30 LUNCH 13:00 Continue with supplier performance data review – John Philips 13:30 Review reporting mechanisms – John Philips
References Time Activity These columns are for Auditor Use only Evidence Notes/Findings Yes No N/A 14:00 Review management review reporting/actions – Bob Irvine View and assess job description vs. actual activity conducted – Bob Irvine Assess competency and training records – Bob Irvine Review how resource requirement is determined – Bob Irvine 15:30 Prepare audit conclusions – Auditor
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 9 of 24 530epaeaudtcocusosudto 16:00 Closing meeting: Feedback to auditee and team – agree follow-up date if required – Auditor Agree follow up date to close out non-conformances if applicable 16:30 END Prepare and distribute the audit report: Note this should be done in a timely manner; next day is good practice – Auditor Writing the report can be the following day (if necessary)
References Activity 5: Work documents (checklists/turtle diagram) Process/activity audited: Supply chain management Requirement Source (at) Evidence (for) Notes Clause 8.4 Control of external providers, processes, products and services Context analysis Regulatory Ensure that a process has been gone through to determine internal and external issues, interested parties and their requirements and needs have been addressed: Obtained evidence that the internal and external issues and needs and expectations of interested parties are being reviewed periodically Documented scope exists Reviewapplicabilityofscopewithreferencetothecontextasabove
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 10 of 24 Context (4.1 – 4.3) Review applicability of scope with reference to the context as above What was the outcome of the context analysis and how has this impacted on purchasing? What are the legal requirements that may affect purchasing? Clause 4.4 Quality management system and its processes Is the purchasing process documented? (Check OML-P06) Are the inputs and outputs evident? Does it include reference to the following: Supplier selection Approved supplier/delegations list Customer nominated suppliers Terms and conditions Supplier PPAP Purchasing/expediting/receipt controls Supplier performance/development Obtain evidence that all of the above are being conducted effectively
References Process/activity audited: Supply chain management Requirement Source (at) Evidence (for) Notes Have the purchasing risks and opportunities been assessed i.e.: Single source Long lead time items Poorly performing external providers How are these being addressed/reviewed? How does supply chain management interact with other processes? Identify linkages and investigate their effectiveness Clause 6.1 Actions to ddikd Risks and opportunities Are customer requirements identified and flowed down to external providers? PPAP Drawings
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 11 of 24 address risk and opportunities Drawings Specifications Do purchase orders contain sufficient information i.e.: Part number/revision Required by date Piece part cost Terms and conditions or reference to them Clause 5.1.2 Customer focus What objectives have been set for supply chain management? How are they monitored and reviewed? i.e.: What are the KPIs? What are the targets? Are they achieved? Clause 6.2 Quality objectives and planning to achieve them Objectives Are sufficient resource available? Have the supply chain management competencies been identified: Job descriptions Roles and responsibilities matrices Succession plans
References Process/activity audited: Supply chain management Requirement Source (at) Evidence (for) Notes 7.1.2 People 7.2 Competence HR for roles and responsibilities and competencies Have all supply chain personnel been trained? Training matrices Personnel files Have appraisals been conducted? 9.1.3 Analysis and evaluation External provider performance measures Is external provider delivery and quality performance being measured? What are the targets? What is being achieved? How are results reported? What is the review process? Whatistheescalationprocessshouldresultsbepoor?
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 12 of 24 What is the escalation process should results be poor? Is this reflected in the approved supplier/delegations list? 9.3.2 Management review inputs Do the results form part of the management review? What actions are subsequently taken? 7.5 Documented information Any documents seen/collected during the above processes are all governed by the requirements of 7.5 Documented information in terms of the control, creation and updating.
References Turtle diagram – Completed Process inputs Customer and regulatory requirements customerordersandschedules Process Supply chain t Process outputs With who Buyer Operations Manager Managing Director QA Manager QA Inspector Storeman With what ERP system
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 13 of 24 How Supplier selection process PF06-01 Supplier Questionnaire PF06-02 Approved supplier list PF06-03 Purchase Order PPAP as per OML-P05 NPI Process customer orders and schedules management process Supplier on time delivery Compliant materials Supplier improvement What is the measure? Supplier delivery performance (DSA) Incidents of premium freight Supplier quality performance PPM Supplier CAR’s raised PPAP RFT PO errors No of certificates out of date Support Process QMS 06 Competencies, documented information, customer satisfaction, nonconformity and improvement
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 14 of 24 Activity 6: Question types Open: Question could start with a ‘who, what, where, when, why, how’ eliciting more information and not just a ‘yes or no’ response, e.g. ‘how does this process work?’ Closed: Question could be: ‘Do you have any allocated responsibilities for this activity?’ Hypothetical: Question could be: ‘What would happen if no-one knew their responsibilities for this activity’? Probing: Question could be: ‘You mentioned that responsibilities have been defined for this activity, but what are they?’ Start with an: Open, probing, then possibly a hypothetical (if assessing effectiveness or improvement etc.), and finally a closed question (which could include confirming your understanding): to arrive at an audit finding. Activity 7 Pathfinder quiz Your tutor will supply the questions and answers to this quiz. Activity 8: Internal audit Your tutor will provide individual coaching and facilitation, as requested, to develop your skills in this area.
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 15 of 24 Activity 9: Nonconformity findings Your tutor and other groups, will critique your team's nonconformity and recommend improvements that come to mind. The below four NCRs contain key NCs you should have observed in the Case Study. Nonconformity Report (NCR) Audit report number: INT/20xx/01 NCR number: 01 Issue date: Jan 20xx SECTION 1 - DETAILS OF NONCONFORMITY: Process/area/ department: Department – Procurement OML-P06-01 Supply Chain Management Process Requirement/ clause numbers(s): 7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable: c) Control of changes (e.g. version control) e) Prevention of the unintended use of obsolete documented information by removal or by application of suitable identification or controls if kept for any purpose Objective evidence: Documents revision levels on the following extracts were not the same as master document control form e.g. QMS 06 Rev 4 Competencies, Documented Information, Customer satisfaction, Nonconformity and Improvement on Master and Rev 3. Statement of nonconformity: QMS Documents are not being controlled as required by 7.5.3. Due Date: Jan 20xx Auditor Auditee representative acknowledgement Name: J. Bloggs Signature: J. Bloggs Name: John Philip Signature: John Philips
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 16 of 24 Nonconformity Report (NCR) Audit report number: INT/20xx/01 NCR number: 02 Issue date: Jan 20xx SECTION 1 - DETAILS OF NONCONFORMITY: Process/area/ department: Department – Procurement OML-P06-01 Supply Chain Management Process Requirement/ clause number(s): 8.4.1.2 Supplier selection process: The selection process shall include; relevant quality and delivery performance … Objective evidence: The 'Supplier Questionnaire’ for Auto Precision Pressings Ltd. Statement of nonconformity: The supplier questionnaire does not include requirements for delivery and quality performance in the selection process. Due date: Jan 20xx Auditor Auditee representative acknowledgement Name: J. Bloggs Signature: J. Bloggs Name: John Philips Signature: John Philips
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 17 of 24 Nonconformity Report (NCR) Audit report number: INT/20xx/01 NCR number: 03 Issue date: Jan 20xx SECTION 1 - DETAILS OF NONCONFORMITY: Process/area/ department: Department – Procurement OML-P06-01 Supply Chain Management Process Requirement/ clause numbers(s): 8.4.3 Information for external providers The organization shall ensure the adequacy of requirements prior to their communication to the external provider. Objective evidence: Purchase order number 12345, was incomplete, i.e. drawing revision for 12345 Hinge LH was not identified on the PO. Statement of nonconformity: The organization did not ensure the adequacy of requirements prior to their communication to the external provider. Due date: Jan 20xx Auditor Auditee representative acknowledgement Name: J. Bloggs Signature: J. Bloggs Name: John Philips Signature: John Philips
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 18 of 24 Nonconformity Report (NCR) Audit report number: INT/20xx/01 NCR number: 04 Issue date: Jan 20xx SECTION 1 - DETAILS OF NONCONFORMITY: Process/area/ department: Department – Procurement OML-P06-01 Supply Chain Management Process Requirement/ clause number(s): 8.4.2.1 Supplier monitoring The organization shall have a documented process and criteria to evaluate supplier performance in order to ensure conformity of externally provided products… Objective evidence: Supplier on-time-delivery performance has been consistently below target and incidents of premium freight has been consistently above the minimum target over a 12 month period with no evidence of corrective action being taken. Reference: Extract from monthly operations meeting (supplier performance metrics) June 20XX. Statement of nonconformity: Supplier performance is not meeting requirements (criteria specified) and there are no actions in place. Due date: Jan 20xx Auditor Auditee representative acknowledgement Name: J. Bloggs Signature: J. Bloggs Name: John Philips Signature: John Philips
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 19 of 24 NCR 01-04 are documented on previous pages and in summary below: NCR 01: QMS Documents are not being controlled as required by 7.5.3.2. Case Study: Page 16. NCR 02: The supplier questionnaire does not include requirements for delivery and quality performance in the selection process (8.4.1.2 Supplier selection process). Case Study: Page 17. NCR 03: The organization did not ensure the adequacy of PO requirements prior to their communication to the external provider (8.4.3 Information for external providers). Case Study: Page 26. NCR 04: Supplier performance is not meeting requirements (criteria specified) and there are no actions in place (8.4.2.1 Supplier monitoring). Case Study: Page 55. A sample of other NCR’s 05-16 are covered below: NCR 05: There is no justification for this exclusion of 8.3 (Design and development of products and services). Clause 4.3 Determining the Scope of the Quality Management System, they need to justify the exclusion. Case Study: Page 4. NCR 06: This issue is identified as high risk, and there is no evidence that there is a plan in place to address safety stock. ISO 9001 clause 6.1 Actions to Address Risks and Opportunities also. 16949 clause 6.1.2.3 Contingency plans c) interruption from externally provided products, processes and services. Case Study: Page 7. NCR 07: Operations manager did not sign the supplier questionnaire as per the company internal requirements. Clause 8.4.2.1 Type and Extent of Control – Supplemental – failure to comply with company requirement. Case Study: Page 24.
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 20 of 24 NCR 08: Not meeting the internal procedural requirement. 8.4.2. d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products, and services meet requirements. It clearly states that all suppliers will be reviewed for currency of certificate, also IATF clause 8.4.2.1 supplemental. Case Study: Page 25. NCR 09: The part number is incorrect i.e. PO states 12345 and the Delivery note states 123455234. Clause 8.4.2 Type and Extent of Control d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products, and services meet requirements. This error was not picked up at receiving inspection. Case Study: Page 27. NCR 10: From the competency matrix Betty Clarke is in training for many competencies, but there is no evidence of this being planned. Reference the training plan for year. Clause 7.2 Competence c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; in particular customer requirements (7.2.1). Case Study: Page 30. NCR 11: From the competency matrix no one is trained in IATF 16949:2016 awareness and there is no plan to conduct training. Reference the training plan for year. Clause 7.2 Competence c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken. Case Study: Page 30. NCR 12: PPAP Submission, Capability study for Flange Height /30.75 ± 1.25mm, Ppk = 0.6777. There a numerous out of control conditions on the control chart more than 12 points on the X-Bar chart. Customer specific requirement for initial capability is ≥ 1.67; the process is not stable. Clause 9.1.1.3 Application of Statistical techniques – Statistical concepts such as variation, control (stability), process capability… Shall be understood and used by employees involved in the collection, analysis and management of statistical data Case Study: Page 48. NCR 13: Appraiser A&B out of control, signed off but no action in place, this is an NCR Out of control appraisers and no actions in place to addresses. 7.1.5.1.1 Measurement system analysis- studies to be conducted in line with current MSA manual, and requirement is to identify the cause and correct. See note opposite. Case Study: Page 51.
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 21 of 24 NCR 14: PO Errors not meeting objective and no actions in place. Clause 6.2.2 Planning how to achieve its quality objectives – no actions or plan in place. Case Study: Page 57. NCR 15: Out of date certificates, not meeting objective and no actions in place. Clause 6.2.2 Planning how to achieve its quality objectives – no actions or plan in place. Case Study: Page 57. NCR 16: Perceived customer satisfaction ‘poor’ reported with three customers and no action being taken. Clause 9.1.2 Customer Satisfaction – shall monitor customers’ perceptions and determine the methods for obtaining, monitoring, and reviewing this information. There is no action taken. Case Study: Page 59. Activity 10: Your closing meeting Your tutor will provide individual coaching and facilitation, as requested, to develop your skills in this area of the audit.
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 22 of 24 Audit report AUDIT REPORT Audit start date: 22/8 20xx Audit finish date: 22/8 20xx Report number: INT/20xx/01 Report date: 22/8 20xx Process(es) audited: Department – Procurement OML-P06-01 Supply Chain Management Process Audited location(s)/site(s) Midlands, UK Audit objectives: The objective of the audit is to evaluate the effectiveness of OMLP06 Supply chain management process and related procedures from initial supplier selection through to delivery of products and services into the organization. Audit scope: Supplier selection and approval and delegations Supplier risk assessment and mitigation Customer nominated suppliers Supplier audit where applicable Purchase ordering/scheduling PPAP Receipt controls Supplier performance monitoring Audit team: Auditor: J. Bloggs Audit criterion Standard (): IATF 16949 Version: 2016 Nonconformity Total number of nonconformities (issued during the audit): 4 Nonconformities: NCR 01 The organization did not ensure the adequacy of PO requirements prior to their communication to the external provider (8.4.3 Information for external providers). NCR 02: Supplier performance is not meeting requirements (criteria specified) and there are no actions in place (8.4.2.1 Supplier monitoring). NCR 03: The supplier questionnaire does not include requirements for delivery and quality performance in the selection process (8.4.1.2 Supplier selection process). NCR 04 QMS Documents are not being controlled as required by 7.5.3.2.
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 23 of 24 AUDIT CONCLUSIONS Audit summary: The audit covered the supply chain process from supplier selection through to supplier performance monitoring. The process is well documented and deployed however there were a number of areas that need slight attention. These are detailed in the NCR’s and in the key issues below. Key issues/concerns requiring top management attention: There were a number of keys issues, these included: 1. Performance measures not evaluated during the supplier selection process 2. Performance measures have not been on target for some time and no effective corrective actions are evidenced (DSA/Premium freight) 3. Key information is missing on POs 4. Maintenance of the approved supplier list 5. There was also an incidence of document issue level with inconsistencies to the master document log Strengths and good practices: The systems used to approve suppliers are very robust, but need expanding. The supply chain management process in general is well deployed. Opportunities for improvement/observations: There could be a benefit in further developing the organizations review process to ensure that issues that are identified are addressed and appropriate actions are taken and verified as effective when intended results are not being achieved. Audit team leader approval Name: J. Bloggs Signature: J. Bloggs Date: Jan 20xx Auditee name J. Philips Report distribution: J.Philips, Bob Irvine
References AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 24 of 24 Activity 11: Audit follow-up Your tutor will lead a discussion on your responses. Activity 12: Reflection quiz Your tutor, and other delegates, will lead a discussion on your questions/learning.
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 1 of 59 Orbit Manufacturing Ltd (OML) Case Study This section contains the Case Study information for a fictitious organization called “Orbit Manufacturing Ltd” (OML). Please note that the documents included in this Case Study contain errors for training purposes only. These documents should not be used as guides for developing management system documentation. ***ASSUME THE CURRENT MONTH IS NOVEMBER 20xx FOR THE PURPOSE OF YOUR AUDITS AND DOCUMENTED INFORMATION INSPECTION*** Orbit Manufacturing Ltd
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 2 of 59 Table of contents 1. Organization background ............................................................................................................. 3 2. QMS scope .................................................................................................................................. 4 3. Context and risk/opportunity (extracts relevant supply chain management process) ...................... 5 4. QMS policy (relevant supply chain management process) .......................................................... 10 5. Organization chart ..................................................................................................................... 11 6. Customer focus (extracts relevant to the organization)................................................................ 12 7. Overview of organizations processes.......................................................................................... 13 8. QMS objectives ........................................................................................................................ 14 9. Competencies ............................................................................................................................ 14 10. Documented information ......................................................................................................... 14 11. Customer satisfaction ................................................................................................................. 15 12. Complaints, nonconformity and improvement .......................................................................... 15 Master document control form (extracts) ......................................................................................... 16 Supply chain management process ................................................................................................... 17 Extract of customer specific requirements (OML-Supplier requirements manual) ............................ 21 Supplier questionnaire ..................................................................................................................... 23 Approved supplier list ..................................................................................................................... 25 Purchase order ................................................................................................................................. 26 Delivery note ................................................................................................................................... 27 Job description ................................................................................................................................ 28 Competency matrix ......................................................................................................................... 30 Training plan ................................................................................................................................... 31 Appraisal plan ................................................................................................................................. 32 Extract of PPAP .............................................................................................................................. 33 KPI matrix ...................................................................................................................................... 58
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 3 of 59 [As an Internal Auditor (of the case study organization) you would already be familiar with Pages 3-15] 1. Organization background Orbit Manufacturing Ltd. was formed by three partners. The first premises were situated in a small factory in the Midlands, UK. After 12 months of trading the company had expanded and had outgrown the premises and moved to the current site also located in the Midlands, UK. In 2013, with the continued growth, the Midlands premises were extended to 22,000 square feet and CNC Machines were introduced to allow the company to expand further and take on more complex automotive work; the site now employs 128 personnel.
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 4 of 59 Doc No QMS 02 Authorised by: QM Version No 3 Date: 13/08/20xx 2. QMS scope 1.1 Scope The manufacture and assembly of high precision components and assemblies to the automotive sector. 1.2 Applicability All clause requirements are applicable to the above scope, except: 8.3 (Design and development of products and services), therefore this is excluded from the scope. Note: This doesn’t include “manufacturing design and development” which cannot be excluded.
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 5 of 59 3. Context and risk/opportunity (extracts relevant supply chain management process) All organizations have issues and specific interested party requirements from time to time. OML considers that issues/requirements are those events that can have a threat, or be an opportunity, to the organization. These issues/requirements can either be from outside, or from inside the organization. Overleaf is a matrix of the identified issues/requirements together with an evaluation of the risks and opportunities. Doc No QMS 03 Authorised by: QM Version No 5 Date: 14/07/20xx
Case Study (Delegate) Internal issues (extracts relevant supply chain management process) No Issues (internal) Outcome/impact Likelihood Severity RPN (L+S) Ranking Opportunity 1 Selection and approval of suppliers/contractors Suppliers and contractors meet OML requirements 3 2 5 M Ensure that supplier selection and approval process is conducted and that provider has the capability to meet requirements 2 Buyers not familiar with supplier approval process andPPAP Suppliers not approved prior to use 2 2 4 M Ensure that all buyers are trained in the supplier selection and approval process. Also ProductionApprovalProcess
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 6 of 59 and PPAP Production Approval Process PPAP. 3 Errors in purchase orders sent to providers Provider will provide incorrect part/service or delivery dates etc. 1 3 4 M Ensure that there is a buddy check on all purchase orders prior to release from OML 4 Approved source not selected when customer nominated source is required Using non-approved supplier when customer has designated a supplier 2 4 6 H Ensure that all customer nominated suppliers are used and set the system so that non approved suppliers cannot be used
Case Study (Delegate) External issues (extracts relevant supply chain management process) No Issues (external) Outcome/impact Likelihood Severity RPN (L+S) Ranking Opportunity 1 Critical supplier suffers interruption due to industrial dispute Reduction of 'raw' material stock at production line. First impact will be felt on local plated parts etc. unable to supply finished goods to customer 3 3 6 H Identify 'safety stock’ of raw material and finished goods. Determine suppliers for dual sourcing of components. 2 Critical supplier unable to fulfil commitment due to major financial problem resultingintheclosureof Reduction of 'raw' material stock at production line. First impact will be felt on local plated parts etcunabletosupplyfinished 2 1 3 L Conduct regular financial reviews of critical suppliers. Determinecriticalsuppliers
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 7 of 59 resulting in the closure of their company etc. unable to supply finished goods to customer Determine critical suppliers 3 Critical supplier unable to deliver material due to transport strike Reduction of 'raw' material stock at production line. First impact will be felt on local plated parts etc. unable to supply finished goods to customer 1 1 2 L Determine which suppliers use subcontracted transport and develop an alternative transport method 4 Critical supplier unable to fulfil commitment due to severe weather conditions Reduction of 'raw' material stock at production line. First impact will be felt on local plated parts etc. unable to supply finished goods to customer 2 3 5 M Identify suppliers where weather conditions may have an impact on delivery and determine safety stocks
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 8 of 59 Organization’s risk analysis OML has considered the risks associated with the supply chain management process above using the following criteria, individually ranking each risk identified according to its likelihood and its severity. Step 1 – Rank the likelihood of a given risk from 1 to 4 using these criteria: 4 = Very likely: Almost certain to occur within the organization or over the life of the project/product (or a 10 year period - whichever is shorter). 3 = Likely: Probably will occur within the organization or over the life of the project/product (or a 10 year period). 2 = Unlikely: Probably will NOT occur within the organization or over the life of the project/product (or a 10 year period). 1 = Very Unlikely: Almost certain NOT to occur within the organization or over the life of the project/product (or a 10 year period). Step 2 – Rank the severity of a given risk from 1 to 4 using these criteria: 4 = Very High: Would prevent company goals and objectives from being achieved. 3 = High: Would cause company significant problems or delays in objectives being achieved. 2 = Medium: Would cause company relatively minor problems or delays in objectives being achieved. 1 = Low: Would probably not affect company. Step 3 – Compute the risk ranking for each risk category. The risk assessment tool will calculate and display these averages automatically. Step 4 – Determine whether each risk category is high, medium, or low according to the following thresholds: 6-8 High Risk (H): You should have a detailed mitigation action. 4-5 Medium Risk (M): You should have a clearly defined mitigation action. 1-3 Low Risk (L): No mitigation action required (or a very basic action if you think it is necessary).
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 9 of 59 How to develop risk mitigation actions For risks that are essentially internal to the company/project (e.g. capacity, leadership, partners, etc.) you should focus on taking action to reduce the risk. For risks that are external to the company/project your response will more likely be to develop contingency plans and monitor the risks. Your overall risk mitigation strategy should be simple, clear and manageable with the resources available. These risks are based upon the analysis above and fall into a number of areas: Robustness of current supply chain management process Competency of buyers Financial health of providers Supplier selection process Where possible controls have been put in place to ensure that risks to our organization and our customer are kept to a minimum. These include: Robust training programmes for all buyers Effective supplier selection controls 6 monthly financial check on critical suppliers These risks are reviewed every six months to establish if they are still risks and if so what the adequacy of controls are.
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 10 of 59 4. QMS policy (relevant supply chain management process) As one of the UK’s leading manufacturers and assemblers of high precision products, we are committed to continued growth, the continual improvement of our quality management system and in satisfying applicable requirements, including statutory and regulatory. We are committed to achieving accredited IATF 16949 certification through cooperation, motivation and effective collaboration with all our interested parties. This will ensure consistency of approach, continual improvement and confidence/trust in our processes to deliver products and services to requirements. OML recognizes the sector demands, and improvements in process understanding and compliance with requirements, this approach will help to ensure the sustainability of our organization; as will the maintenance of our organizational knowledge for the consistent provision of product and assemblies, and for business continuity purposes. Therefore critical to achieving this is developing and maintaining a supply chain that meets customerspecific requirements, through a robust supply chain management process. This policy shall be communicated to all employees via team briefing and via the company intranet with the opportunity for them to seek clarification where required. Where required the policy shall be communicated to all interested parties and is available publically on our website. Doc No QMS 04 Authorised by: QM Version No 2 Date: 30/06/20xx
Case Study (Delegate) 5. Organization chart Business Development Director Managing Director Financial Manager Operations Manager
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 11 of 59 Note: Quality manager is the process owner for the AuQMS Workshop Manager Quality Manager Office Manager Engineering Manager Engineering Dept Administration Accounts Chief Inspector Quality Machine Shop Supervisor Store Foreman Scheduling Purchasing Goods Inwards Packing/ Despatch Inspection Team Production Team
Case Study (Delegate) AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 12 of 59 6. Customer focus (extracts relevant to the organization) OML has a constant focus on their customers and their satisfaction, this is demonstrated through our ability to consistently provide high precision components and assemblies that meet customer and applicable regulatory requirements and; To enhance customer satisfaction through the: Effective application of the automotive quality management system (AuQMS) Processes for continual improvement of the AuQMS Assurance of conformity to customer and applicable statutory and regulatory requirements To reducte in waste, during manufacturing, through reduced rejects, effective corrective action and improvements in process understanding and compliance To assist in the creation of an effective knowledge database for the consistent provision of product, and for business continuity purposes Doc No QMS 05 Authorised by: Business Development Director Version No 5 Date: 02/09/20xx
Case Study (Delegate) 7. Overview of organizations processes Orbit Manufacturing Ltd Process Interaction Map Context Improvement Organization Context OML-P10 Continual Improvement Process OML-P09 Non Conformity and Corrective Action Operation Payment Leadership and performance evaluation OML-P02 Business Planning and Management Review Process OML-P08 Internal/second party Audit Process
AUT03001ENGX v1.0 Jan 2017 ©The British Standards Institution 2017 13 of 59 Planning and Support Customer & Stakeholder Requirements Customer & Stakeholder Requirements OML-P07 Manufacturing Process Customer Feedback Customer order OML-P11 Risk Management /Analysis OML-P01 Documented Information Process OML-P03 Training & Human Resources OML-P04 Sales & Enquiry Process OML-P06 Supply Chain Management Process OML-P05 New Product Introduction Process (APQP) Customer Process Operation Process Support Processes Quotation /Tender request Finance/ Accounts