INSERT YOUR COMPANY NAME HERE AS 9100 D. Quality Management Systems. Quality Manual / Documented Information. Document No. QM-9100-D.

Transcription

1 INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D AS 9100 D Quality Management Systems Quality Manual / Documented Information Document No. QM-9100-D Street Address City, State, Zip Tel, Cell Phone: Web Site: 1

2 INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D Section C Document information a. Distribution control list As required with procedure P-750 for Control of documented information. Quality Manual latest revision: Letter: Date of Issue: Issued by: The status of the quality manual and/or description of changes are provided in the revision status page of this manual. Controlled copies are issued to: Copy No. 1 Copy No 2 Copy No. 3 Copy No. 4 Copy No. 5 President Vice President Treasurer / Bookkeeper / Accountant Administrative Officer Quality Manager Management representative / Quality team leader Operations Manager Technical Manager Materials Manager Human Resources Manager Education/training Officer The master copy is held by the Management representative / Quality team leader. This manual is issued and controlled by the Management representative / Quality team leader. All matters or inquiries relating to its contents or usage are to be referred to that individual. It is the responsibility of all holders of the above controlled copies to: Ensure that this manual is read by and available to the personnel under their control. Ensure that superseded pages are returned to the Management representative / Quality team leader. Uncontrolled copies of this manual will be identified with the word "uncontrolled" in bold letters across this page 7

3 INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D For example, the FD Process Flow Diagram represents each step in the manufacturing process and includes other relevant factors associated with the steps. Process Flow Relevant Factors 1 Sources of Materials Raw materials, products and other components are purchased and received Approved suppliers, Incoming inspections 2 Hauling, Transportation Personnel - Manpower Equipment -Trucks 3 - Existing Operations and Production Manpower Laborers Machines Automation Quality control Operator self-inspect 3. a - New Production (x) New Machines Manpower Laborers Training machines, maintenance Operator self-inspect, 4. Products, services for delivery Products, Subassemblies, Components. Servicing Sales and Marketing 5. Deliveries to customers Manpower - Drivers Equipment Trucks Permits 6. Income - Invoice for products/services delivered 12

4 INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D Section D Document information Form F This list of Documented Information covers the AS 9100 D standard clauses 4 through 10 and provides the responsibility, approval date, and revision status for the documents. The QM designation indicates a Quality Management System Manual. The P designation indicates Procedures. The WI designation indicates Work Instructions. The number following the document numbers listed in the Document column below identifies the clause of the standard that the document is associated with. Additional documented information relevant to procedures and instructions is outlined in the spreadsheets of Master Documentation Lists, form F Doc. # Description Responsibility Approve date Quality Management System QM-9100-D QMS Manual President Clause 4 Context of the Organization P-400 Organizational context President Clause 5 Leadership P-500 Leadership President Clause 6 Planning P-600 Planning for the QMS Management Representative Revise date Revise date P-612 Risk management process Management Representative Clause 7 Support P-710 Resource management Operations manager P-715 Control of monitoring and measuring equipment P-720 Competence and awareness Management representative H R manager P-740 Communication Management representative P-750 Control of documented information Management representative WI Document numbering system Management representative 13

5 Documents in MS Word for easy editing. INSERT YOUR COMPANY NAME HERE Quality Manual QM-9100-D Section R Records Documentation Matrix Form F This section of the Manual contains the Records Documentation Matrix. The last column indicates where in the QMS the documents are used. A sample of the latest attachment, form, registers and flow diagram is included. Additional documented information relevant to attachments, forms, registers and flow diagrams is outlined in the Records table, form F Doc # Description of document 1st Rev. Date Last Rev. Date Used with Manual, Procedure, Instruction Attachments A Quality Policy P. 9 Manual QM-9100-D / P-500 / P-740 A Organization Chart P. 10 Manual QM-9100-D / P-500 / P-600/ P-740 A PDCA guidelines P-600 / P-740 A Guideline- Evaluation and selection of providers P-840 Forms F QMS-Process identification worksheet P-400 / P-600 / P-810 P-851 F Organizational context worksheet P-400 / P-600 F Risk and opportunity worksheet P-600 / P-740 / P-811 P-1010 F Risk management plan P-612 F Risk list P-612 F Quality objectives planning record P-600 F Equipment problem report P-710 / P-715 F Resource maintenance record P-710 F Calibration register P-715 F Training action plan P-720 F Group training record P-720 F Job description P-720 F Employee training P-720 summary 16

6 INSERT COMPANY NAME/LOGO HERE AS 9100 Rev D - Quality Management Systems The Gap Analysis Checklist This gap analysis checklist is prepared for use in evaluating a Quality Management System (QMS) against the requirements of the new Aerospace standard. The AS 9100 Rev D standard includes the requirements of ISO 9001:2015 and specifies additional aviation, space, and defense (ASD) industry requirements. In the checklist, each requirement is expressed as a question that the user (auditor / assessor) can use to evaluate your QMS capabilities. You will need to have copies of the AS 9100 D and ISO 9001:2015 standards to use along with this checklist so that, if required, you can refer to the requirements and the clarification sections of Annex A. While the structure of the AS and ISO standards are the same when comparing the contents, the additional ASD requirements are highlighted in yellow in the relevant sections of the checklist and the intent of the main clauses of the new standard is shown in blue font. After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy each section of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and what needs to be developed. In the space for currently in place, list or reference the procedures or other documents, or evidence that you have reviewed and that will provide information for the new QMS. Take notes on the status of the documents, that is, will they need to be revised for the new system, or can they be used as is? Also note where processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed. While you do want to know if documented information is in place and if procedures and processes are being complied with, compliance is not your main focus for this audit. Remember that the final outcome of this audit should be a list of things that your company needs to do to comply with AS 9100 Rev D QUALITY MANAGEMENT SYSTEMS REQUIREMENTS Currently in Place Compliant YES / NO? If No - % Completed Items Needed 4 CONTEXT OF THE ORGANIZATION Intend of clause This first clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its context and (2) understanding the needs and expectations of interested parties. Together they require that you determine the issues and requirements that can impact on the planning of the Quality Management System (QMS). In addition, the scope of the QMS and the QMS processes along with their applicability and interactions need to be determined. IAQG-Oct Audit conducted by: Date: to Copyright AS9100Store Page 1 of 76

7 INSERT COMPANY NAME/LOGO HERE AS 9100 Rev D - Quality Management Systems The Gap Analysis Checklist 4.3 Determining the scope of the quality management system To establish the scope of the QMS, does your company determine the boundaries and applicability of the QMS? When determining the scope of the QMS, do you consider the: External and internal issues (per 4.1)? Requirements of relevant interested parties (per 4.2)? The products and services of your company? When a requirement of AS 9100 D can be applied, is the requirement applied by your company? When requirements cannot be applied, and in order to claim conformity to AS 9100 D, how do you determine if your ability or responsibility to ensure conformity of products and services are not affected? Is the scope of the QMS available and maintained as documented information? Does the scope state the products and services covered by the QMS? Does your company provide justification for any instance where a requirement of the standard cannot be applied? IAQG-Oct Audit conducted by: Date: to Copyright AS9100Store Page 3 of 76

8 INSERT COMPANY NAME/LOGO HERE AS 9100 Rev D - Quality Management Systems The Gap Analysis Checklist 4.4 Quality management system and its processes As required by the standard, do you establish, document, implement, maintain and continually improve the QMS? Does the QMS also address customer and applicable statutory and regulatory quality management system requirements? Does your company determine the processes needed for the QMS, their interactions and applications throughout your company? That is, for the QMS processes do you determine the: Inputs required and the outputs expected from the processes? Sequence and interaction of the processes? Criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of the processes? Resources needed and ensure they are available? Assignment of the responsibilities and authorities for these processes? Risks and opportunities (per 6.1), and plans to implement the appropriate actions to address them? See also Operational risk management (per 8.1.1) IAQG-Oct Audit conducted by: Date: to Copyright AS9100Store Page 4 of 76

9 INSERT COMPANY NAME/LOGO HERE AS 9100 Rev D Quality Management Systems - The Internal Audit Checklist 4.3 Determining the scope of the quality management system To establish the scope of the QMS, does your company determine the boundaries and applicability of the QMS? When determining the scope of the QMS, do you consider the: External and internal issues (per above clause 4.1)? Requirements of relevant interested parties (per above clause 4.2)? The products and services of your company? When a requirement of AS 9100 D can be applied, is the requirement applied by your company? When requirements cannot be applied, and in order to claim conformity to AS 9100 D, how do you determine if your ability or responsibility to ensure conformity of products and services are not affected? Is the scope of the QMS available and maintained as documented information? Does the scope state the products and services covered by the QMS? Audit conducted by: Date: to Copyright AS9100Store Page 3 of 79

10 INSERT COMPANY NAME/LOGO HERE AS 9100 Rev D Quality Management Systems - The Internal Audit Checklist 5.2 Policy Developing the quality policy Has your top management established, implemented and maintained a quality policy that: Is appropriate to the purpose and context of the organization? Provides a framework for setting and reviewing quality objectives? Includes a commitment to satisfy applicable requirements? Includes a commitment to continual improvement of the QMS? Communicating the quality policy Is your quality policy: Communicated, understood and applied within your company? Available as documented information? Available to relevant interested parties? Additional Questions Audit conducted by: Date: to Copyright AS9100Store Page 9 of 79

11 INSERT COMPANY NAME/LOGO HERE AS 9100 Rev D Quality Management Systems - The Internal Audit Checklist Creating and updating When creating and updating documented information, does the company ensure: Identification and description, such as a title, date, author, or reference number? Format, such as language, software version, graphics and media, such as paper, electronic? Review and approval for suitability and adequacy? NOTE: Approval implies authorized persons and approval methods are identified for the relevant types of documented information, as determined by the organization. Additional Questions Control of documented Information Do you control the documented information required by the QMS and by the AS 9100 D standard to ensure that it is: Available and suitable for use, where and when it is needed? Audit conducted by: Date: to Copyright AS9100Store Page 24 of 79

12 INSERT YOUR COMPANY LOGO/NAME HERE P-920-A Internal Audits 1.0 Purpose/Scope 1.1 This procedure describes the process for performing Internal Audits at Your Company. 1.2 The procedure applies to the audit of the QMS where performance is evaluated. 2.0 Responsibilities and Authorities 2.1 The President has the prime responsibility and approval authority for this procedure. 2.2 In support of the President, the Quality team / AS steering committee is responsible to ensure that internal audits are conducted at planned intervals. 2.3 Additional responsibilities for the Quality team leader / Management representative / audit coordinator, lead auditor, auditors, management staff, employees, and the corrective action coordinator are detailed in relevant paragraphs of section 5.0 below. 3.0 References and Definitions 3.1 Reference This document relates to clause 9.2 of the AS 9100 D standard, Internal audit. Recommendations for customization are included in blue type. Definition Audit Team: May be one or more auditors, including the lead auditor. 4.0 Resources 4.1 None 5.0 Instructions 5.1 In support of the procedure P-910 for Monitoring, measuring, analysis and evaluation, this procedure addresses the internal audits of the QMS Internal audits are conducted to ensure that the QMS conforms to Your Company s own requirements and to those of the AS 9100 D standard, is effectively implemented and maintained, and continues to be suitable, adequate and effective The company s own requirements include customer and applicable statutory and regulatory quality management system requirements. The President / Quality team / AS steering committee ensure that internal audits are conducted at planned intervals at a minimum of two times per year. At the call of the President, internal audits may be conducted more frequently based on performance and results observed during previous audits. Performance indicators can be evaluated to determine whether the Internal audits Page 1 of 5 Date printed 11/9/16 1:39 pasdite

13 INSERT YOUR COMPANY LOGO/NAME HERE P-920-A Internal Audits The audit coordinator or management staff person is responsible forall Documents are initiating corrective actions. number to comply with document control The audit team holds a closing meeting with the representatives of the requirements. area audited, including a management person with responsibility for the area audited. All observed non-conformances are explained and the status of the area audited is summarized The lead auditor prepares an internal audit report on form F The report includes: A summary of the findings A table of corrective action requests A copy of each corrective action request The audit report is distributed to the attendees of the opening and closing meetings. The lead auditor puts all audit records into the audit file The records included are the internal audit plan, the auditors checklists, and the internal audit report, including the table of corrective action requests The records are retained, with the procedure P-750 for Control of documented information, as evidence of the implementation of the audit program and the audit results. 6.0 Forms and Documented Information 6.1 Forms F Applicable Procedures by Work Area F Audit Checklist F Internal Audit Plan F Internal Audit Report F Corrective action request - CAR Documented information / Related processes P-600 Planning for the Quality management system P-750 Control of documented information P-910 Monitoring, measuring, analysis and evaluation P-930 Management review P-1020 Nonconformity and corrective action Opportunities and Risks Internal audits Page 4 of 5 Date printed 11/9/16 1:39 pasdite

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