| Chapter |
Contents |
| Chap. 4.3 |
- In Chapter 5 (Scope) of the QM Manual, Rev. 2.3, the organization describes the exclusions. The exclusions are not listed in full; clause 8.5.1.2 of the standard is missing.
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| Chap. 4.4 |
- The QM manual was created by another company; only the company name and the organizational chart were changed.
- Selected KPIs for core processes are not suitable for determining their performance.
- Recruitment, as a key process of the organization, is not formally identified in the quality management manual (in the case of a recruitment agency).
- The interface between the xyz and wxy production departments is not adequately regulated.
- No current QM manual could be provided. Only the outdated version from the previous year was available for review.
- Key performance indicators that ensure the effectiveness of these processes are not available for all support and management processes. These are also missing from the scope of the assessment in the 2013 Management Review. Key performance indicators for the product realization processes have not been consistently defined.
- No appropriate KPIs have been defined or implemented.
- No adequate KPIs have been defined for the processes; only financial KPIs are available.
- For extended workbenches or outsourced processes, the interfaces were not described in the manual, and no checks were performed upon delivery or receipt of goods.
- No output has been defined for the “Internal Development Projects” process.
- No plans or measures for verifying the conformity of the quality management system could be provided.
- Employees are not sufficiently familiar with the quality management documentation.
- An organizational chart or other documented plan or overview of resources could not be provided.
- No evidence of a documented training plan, as required by QMH, could be provided.
- Employees had not been trained in their processes; in some cases, they were unfamiliar with the QMH.
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| Chap. 5.3 |
- The responsibilities and authorities defined within the company are not clearly defined. The signature specimen (“Signature Specimen with Authorities”) specified in Chapter 5.3 of the current Version 6 of the manual has not been used since 2009.
- There is no assurance that the processes required for the QMS will be implemented, carried out, and maintained. The continuity of previously established continuous improvement measures (CAR 5 from the last surveillance audit, ref. 10.2) cannot be verified and cannot be demonstrated.
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| Chap. 6.2 |
- The company has not established any corporate goals.
- The quality objectives are not reviewed annually and adjusted as appropriate.
- Quality targets for the current year could not be provided.
- Quality targets could not be provided.
- Quality objectives are not available in a measurable form.
- Quality targets could not be demonstrated in a quantifiable form.
- In the Project Management process (8.1), no root cause analyses or corrective actions have been defined for 2 out of 3 process metrics that deviate from the targets.
- The company’s goals were not up to date, and their implementation had not been evaluated.
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| Chap. 7.1.3 |
- Data backups and monthly backups were performed on freely accessible PCs in the offices. During the audit, an update was installed simultaneously on both “long-term” (monthly) hard drives.
- The Group’s IT processes have not been defined.
- There are insufficient resources available to ensure the maintenance and monitoring of the QMS processes.
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| Chap. 7.1.4 |
- No records of humidity and temperature are kept in the storage area.
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| Chap. 7.1.5 |
- The calibration date on a tensile testing machine had expired by nearly 2 years.
- The procedure for recalling monitoring and measuring equipment has not been defined.
- The procedure for recalling monitoring and measuring equipment has not been effectively established. Furthermore, measuring equipment was found that continued to be used even though its calibration date had passed.
- The calibration certificate for the external calibration (BM No. 029) of the multimeter could not be provided.
- The test results listed in the measuring equipment inventory (actual test characteristics) do not meet the requirements for monitoring and measurement (tolerances are too wide or undefined; reference values are not precise enough). The test date is missing, as is the tester’s signature.
- The list of monitoring and measuring equipment is not exhaustive.
- The list of measuring equipment does not include all measuring equipment. The maintenance and calibration of some measuring equipment has not been performed on time.
- Some measuring and monitoring equipment was not managed in accordance with the standards; for example: soldering irons were not checked regularly for soldering temperature, and radiometer xyz was not marked as “not serviceable.”
- Some measuring instruments in the plastic parts assembly area are not controlled or monitored.
- Controlled clock (Diacator) is not marked and is not listed in the measuring equipment overview.
- Although the KS 1/05 verified caliper bears a valid calibration seal, it turns out to be defective upon inspection.
- The list of calibrated measuring instruments was not up to date.
- The measuring instruments did not have calibration labels.
- The list of measuring instruments is not up to date; the XY caliper is not included in the list.
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| Chap. 7.2.1 |
- The QMB has no QM training whatsoever.
- The QMB’s qualifications could not be verified with the appropriate documentation.
- The QMB’s qualifications, competence, and understanding of standards are insufficient. The tasks described in the QM manual cannot be fully assumed or carried out.
- The certified internal auditors have not received any training and have no proof of competence.
- The auditors’ qualifications could not be verified.
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| Chap. 7.2 |
- Adequate records of training could not be provided. Objective evidence: lack of training and instruction records for the milling machine and the ERP system.
- Evidence to verify the effectiveness of the training measures implemented could not be provided.
- Evidence of the necessary skills and competencies of personnel performing work that affects product requirements could not be provided.
- The documentation regarding employee training is insufficient.
- The staff’s training needs for their assigned tasks have not been documented.
- The effectiveness of the training measures implemented is not systematically evaluated. (Minutes of the 360° feedback meeting)
- A training plan and documentation of completed training sessions and briefings could not be provided.
- No assessment of the necessary competencies for personnel who perform work that affects product requirements could be provided.
- No training records are kept for temporary staff.
- No proof of training was provided for the period covered by the audit. Nor was any training plan submitted.
- During the development phase, it was not possible to verify the specific qualifications in the aviation sector.
- No training plan was created or the training was not conducted according to the plan; changes were not recorded.
- There is no systematic assessment of necessary workforce development needs (skills, competencies, etc.). Company-specific documentation and records are not evident.
- There are no established criteria for auditor training.
- The competency matrix is not up to date; not all employees are listed.
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| Chap. 7.5 |
- The document control procedure is not fully implemented. The revision status and approval date do not match.
- It is unclear how the current status of the technical documentation is monitored, e.g., CMM, AMM, SRM.
- In various departments (e.g., Goods Receiving, Production Control), procedure manuals were found that had not been approved.
- Uncontrolled documentation was found in various parts of the company: for example, documents were not marked “for information only.”
- System error in the QM software related to versioning. The change date and version number do not match. Additionally, it should be possible to approve forms.
- Records are incomplete: records related to training, job descriptions and/or competency matrices, etc.; supplier evaluations; a list of specific processes; internal audits (plan, checklist, report); an overview of measuring equipment and supporting documentation; corrective actions; and preventive actions.
- The form (Employee Orientation) does not comply with the requirements of EN 9100, Section 7.5.2 (Records).
- Procedure VA 4-3, “Record Management,” does not adequately describe how records are handled.
- In accordance with Chapter 1.4.2 of the QM Manual, the training of new employees must be documented using the “New Hire” checklist. The checklist is available, but no evidence of training could be provided (even though employees were hired during the monitoring period).
- No information provided regarding the archiving of records VA 4.5 No retention periods specified for documents and records.
- Quality records are sometimes kept on non-controlled documents (work plan, parts slip).
- Test reports and worksheets were not filled out completely.
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| Chap. 8.1 |
- The monitoring of planning activities is not adequately reflected in the associated software (e.g., project planning).
- The preparation of maintenance work sheets, including descriptions of the work steps, is insufficient (for example, there is no work step for MPI, and the reference to the CMM was not always correct).
- Requirements from the internal authorization process (power of attorney policy) are not being followed.
- The “Acceptance” process step in the outsourced “Assembly” process could not be documented as described in the QM Manual.
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| Chap. 8.1.1 |
- The risk definition is not sufficiently described (risks, root causes, and consequences are not described).
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| Chap. 8.1.2 |
- No configuration management is installed.
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| Chap. 8.1.4 |
- The procedure for protecting against suspected unapproved parts is not effective.
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| Chap. 8.2 |
- The “Negotiate and Conclude a Contract” process describes a contract review, but only a review of the purchase order is performed.
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| Chap. 8.3.4 |
- No records of the results of the development assessment for Project XY or of the necessary measures could be found.
- The release of a development stage (milestone) was performed by an unauthorized employee.
- No records of the results of the development verification or of the necessary measures could be found for Project XY.
- Although the qualification test failed, no nonconformity report was issued.
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| Chap. 8.4.1 |
- No records of the evaluation results or the necessary actions related to the supplier evaluation could be found.
- Records of supplier evaluations could not be provided. Audited example: For Company XYZ, although it was an A-level supplier, no records could be found.
- No records of supplier evaluation, selection, or other results could be found.
- The established procedure for evaluating suppliers does not reflect the actual process.
- The criteria for supplier selection, evaluation, and re-qualification are not documented.
- No risks were identified in the selection of key suppliers.
- There is no list of approved suppliers.
- Suppliers were classified as A or B, but no classification method was described in the QMH.
- The procurement process described is not being followed, as the requesting project management team is responsible for the entire process—not just the supplier selection, as described in the procedure manual. The process owner merely archives the documents submitted in c/c.
- The supplier evaluation as specified in Procedure PB-09, “Supplier Monitoring,” does not match the actual evaluation process. (Evidence: Evaluations of XXY GmbH and XY AG).
- The list of approved suppliers is out of date (2013).
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| Chap. 8.4.2 |
- For outsourced development: The associated process does not provide sufficient detail for planning and monitoring.
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| Chap. 8.4.2.1 |
- Test reports from suppliers that were required by the customer are not validated.
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| Chap. 8.4.3 |
- The procurement specifications do not include a requirement to extend the applicable requirements to the supply chain. Neither Process P 8.4-01 nor Form FB-8.4-01 (Procurement Request) contains any instructions to extend the applicable requirements to the supply chain.
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| Chap. 8.5.1 |
- The workstation used to inspect the conformity of parts manufactured by Machine XY was unsuitable for inspecting the parts (insufficient space, clutter, no adequate work surface, defective measuring tool).
- Product responsibility within the manufacturing process is not adequately ensured and tends to be conflated in practice.
- In the case of XY, proof of product testing in accordance with the specifications could not be provided.
- The revision status of the XYZ standard document used was not clearly specified in the work card.
- The availability of information describing the product’s characteristics could not be clearly linked to the product.
- Several illegible or incomprehensible handwritten comments were identified in the approved production specifications.
- Not all test procedures were carried out as planned or otherwise documented and approved.
- No inspection reports could be provided for the audited order XY. Reports on outgoing goods inspections could not be provided either.
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| Chap. 8.5.1.1 |
- Production equipment is not being maintained.
- Maintenance planning has not been formalized; the planning is neither reliable nor consistent.
- There is no set approval process for CNC programs.
- It could not be verified that the daily test on the hardness tester had been performed.
- The weekly maintenance (checking the concentration of the rust inhibitor) on machines M8 and M13 was not documented.
- There is no maintenance or service history data available for tool RE 1411.
- No proof of compliance with the product specification regarding age-related and routine maintenance for the punching machine could be provided.
- Maintenance and servicing on Machine XY were not performed.
- The maintenance schedules for the machines do not include information about which machine is involved, nor do they include information about maintenance requirements (maintenance tasks, maintenance intervals).
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| Chap. 8.5.1.2 |
- The handling (particularly testing requirements) of special processes is not being implemented in accordance with the specifications in the manual, Rev. 7.1.
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| Chap. 8.5.2 |
- Although traceability had been documented, the batches in the warehouse were not labeled.
- a) Rejected parts in the rejected parts storage area are stored together with good parts and are not marked as rejected. b) The rejected parts storage area is not sufficiently separated from the regular storage area. c) Rejects from production on machine C23 were not marked as rejected.
- The material labels on the material rack had not been updated after sections were cut off. It was no longer possible to determine which type of material was present.
- During two spot checks at the receiving department, it was not clear to the employees which requirements (inspection points) the goods were to be checked against.
- It is not possible to fully trace the product’s compliance with the acceptance criteria throughout the product development process. To address this, documentation must be created and maintained throughout the product development process.
- Storage of material without documentation; the start and end times for pre-swelling O-rings are not identifiable.
- No secure storage facility had been set up.
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| Chap. 8.5.4 |
- The shelf-life and temperature requirements for sensitive manufacturing materials do not match the actual storage conditions.
- The service life of materials with a limited lifespan had expired.
- Monitoring of shelf life and inventory levels is not in accordance with company guidelines and the standard.
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| Chap. 8.6 |
- The test sensitivity was changed without authorized approval.
- In some cases, workers are not sufficiently familiar with the guidelines for self-inspection, and in some cases, access to the guidelines is not sufficiently available.
- The checklists for testing devices have not been filled out correctly.
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| Chap. 8.7 |
- The qualifications of the MRB members are not apparent.
- There are defective products in the production area, some of which are not clearly marked or routed. The status of the rejected products is not sufficiently clear from the production tracking card.
- Material intended for scrapping was not marked as such.
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| Chap. 9.1.1 |
- The key performance indicators presented are not being fully utilized to guide decision-making or to improve the management system. The top-down derivation of the key performance indicators is not sufficiently transparent.
- There is no evidence of a systematic analysis of key performance indicators to develop process optimizations.
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| Chap. 9.1.2 |
- The procedure for determining customer satisfaction specified in the QM manual is no longer current; data is not available, and evidence of the procedure being followed cannot be provided.
- No systematic customer satisfaction management plan could be presented.
- An analysis of errors that occurred and the related customer complaints could not be provided.
- A documented review of customer requirements and/or an analysis of customer satisfaction could not be provided.
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| Chap. 9.1.3 |
- Customer complaints and reports of defects or errors have been received. However, these are not analyzed to identify corrective actions that would systematically prevent their recurrence.
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| Chap. 9.2 |
- The audit reports from the internal audits conducted in 2013 could not be provided.
- Internal audit reports could not be provided at the time of the certification audit.
- The 2012 audit plan was completed; there is no audit plan for 2013, and no internal audits were conducted.
- The Quality Management department was not audited (internal audit).
- It is not clear that the auditors assigned to the case are independent of the unit being audited.
- The auditor’s impartiality could not be verified, as, according to the Internal Audit Policy, only the QMB serves as the internal auditor. Proof of the auditor’s qualifications could not be provided.
- Management does not adequately monitor or address audit findings in a timely manner.
- An audit program could not be provided.
- A program for conducting internal audits and a documented audit could not be provided.
- The corrective action from Audit Report XY has not yet been completed by the Purchasing Department, despite two reminders.
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| Chap. 9.3 |
- An assessment of the effectiveness of the measures taken in response to the findings of the last management review, as well as a review of target achievement, could not be provided due to the absence of a management review (and because no such information was available in any other record).
- No management review was provided for the audit period.
- Management review is missing.
- Management review not performed.
- The management review dated December 18, 2015, does not include all the inputs and results required by the standard.
- Follow-up actions from previous management reviews are not reflected in the current review.
- The results of the management review must be presented more transparently, and the resulting improvements must be outlined along with responsibilities, deadlines, and resources.
- The management review was conducted. However, the results were not documented in the manner required by the standard and the company’s own quality management manual.
- Documentation or a record of the 2015 management review could not be provided.
- The management review dated August 27, 2015, listed the results; however, it does not include a breakdown of how these results translate into specific actions with assigned responsibilities and deadlines.
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| Chap. 10.1 |
- No willingness to improve is apparent.
- No root cause analyses are conducted for internal audit findings.
- A “Preventive Action Board” has been established to determine preventive measures. However, the documented procedure does not specify how this board is convened or who invites members to its meetings. No frequency has been established for the meetings.
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| Chap. 10.2 |
- In two of the complaint procedures examined (BA2265, BA2237), the procedures were marked as closed even though there were no sufficient and conclusive root cause analyses and no corrective actions had been defined.
- The changes to the QM Manual and related documentation were not implemented in accordance with the QMB/GL agreement (based on the findings from Stage 1).
- No root cause analysis of internal and external audit findings was conducted.
- No proper root cause analysis was conducted.
- The causes of errors are identified and corrective actions defined; however, the description in the corresponding report is incorrect and incomplete, making it impossible to understand the cause of the error, the overall context, and the consequences. Incorrect problem description, incomplete description of measures: Was the process adapted? Was the material changed? What was done with the defective batch?
- Do not accept inadequate explanations (root cause analysis) from the supplier.
- Root cause analysis for deviations was insufficient; Method 5W was not applied.
- Of the 7 corrective actions that were specified, none were implemented.
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