EB2678 ISA Audit Preparation Gap Analysis Audit Report For Globe Composite Solutions
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Executive Summary
This audit report highlights key opportunities for improvement in Globe's quality management systems and processes. By addressing these findings through the development and execution of Corrective Action Plans (CAPs), can enhance it’s operational success. Fostering a sense of accountability and ownership, within the organization, will be essential in driving improvements and ensuring compliance with both internal and customer requirements.
Key Points of Opportunity
Corrective Actions
Culture of Quality
Globe has an opportunity to elevate initiative and ownership by promoting a culture of quality within the organization, where everyone owns quality. By fostering a culture of accountability and proactive problem-solving, measurable improvements can be achieved.
There is an opportunity to improve the follow-through of Corrective Actions, which is essential for strengthening the effectiveness of the quality management system. Enhancing these areas will increase the system’s reliability, ensure consistent adherence to standards, and promote a culture of continuous improvement.
Supplier Management System
Non-Compliance with Customer Requirements
The audit identified opportunities for improvement in the supplier management system, particularly in the use of supplier scorecards and procedures. Addressing these gaps will enhance supplier performance monitoring and ensure adherence to requirements.
The organization has an opportunity to improve compliance with customer requirements as stipulated in purchase orders (POs) and contracts. Enhancing understanding and implementation of Coded Note and standard clause requirements will ensure adherence to customer specifications and expectations
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Observations:
Facility Cleanliness:
EHS Program:
The facility is exceptionally clean, with commendable housekeeping practices. This cleanliness contributes to a safer and more efficient working environment by minimizing hazards and ensuring that all areas are organized and free of clutter. The attention to housekeeping details reflects the company's commitment to maintaining high operational standards and fostering a culture of excellence.
The EHS program is well-maintained, with no violations of safety or environmental regulations found. This demonstrates a strong commitment to health, safety, and environmental stewardship. The absence of violations ensures a safe workplace for employees and minimal environmental impact.
MT&E Usage:
A calibrated tool was found in use without a dust cover and had been modified by a quality inspector. This could lead to potential errors in test results, highlighting the need for strict adherence to tool maintenance and modification protocols. The use of modified tools greatly increases the risk of inaccuracies, which can compromise the integrity of all parts tested in this manner. This raises the potential for nonconforming parts, impacting product consistency, reliability, and ultimately, customer satisfaction.
Production Controls:
Production controls are highly effective and consistently in place, enabling the seamless execution of manufacturing processes. These controls include detailed process documentation, real-time monitoring systems, and regular audits to ensure compliance. The robustness of these production controls minimizes downtime, reduces errors, and enhances overall productivity, thereby contributing to the company's ability to meet customer demands reliably.
Gemba Walks:
The VP of Engineering actively engages in Gemba Walks with the team periodically, a practice that has led to the implementation of best practices across the production floor. These walks involve direct observation of work processes, allowing for immediate identification and resolution of issues. The hands-on approach of the VP of Engineering fosters a culture of continuous improvement and accountability, with team members regularly updating and optimizing procedures based on real-time feedback and observations.
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Quality Findings:
Multiple quality findings were noted concerning documentation control and the closure/completion of Corrective Action Requests (CARs). Key issues include opportunities to enhance initiative and ownership, improve corrective actions, strengthen supplier and quality management, and ensure compliance with customer requirements. These areas highlight the organization’s opportunity to reinforce high standards, with leadership's involvement and guidance. Proactive leadership and thorough oversight can foster accountability, ensure effective corrective actions, and manage supplier quality. With this proactive approach, the entire team can adhere to quality protocols and consistently meet customer expectations.
Summary
During the plant tour and audit interviews with team members on the shop floor and in the warehouse, several key observations were made.
The facility's cleanliness and housekeeping practices are exemplary, creating a safe and organized work environment. Effective production controls are consistently enforced, ensuring smooth manufacturing operations and high productivity. The VP of Engineering's periodic Gemba Walks have successfully fostered a culture of continuous improvement and best practices on the production floor. The EHS program is well-maintained, with no safety or environmental violations observed, reflecting a strong commitment to health, safety, and environmental stewardship. However, multiple quality findings were noted, including issues with documentation control and the closure/completion of Corrective Action Requests (CARs). Specific issues include opportunities to improve initiative and ownership, deficient corrective actions, inadequate supplier management, and non-compliance with customer requirements. Additionally, a calibrated tool was found in use without a dust cover and had been modified by a quality inspector, raising concerns about potential errors in test results. These deficiencies highlight the opportunity for the organization to reinforce its role in maintaining high standards, with proactive leadership and guidance being essential. A proactive approach and thorough oversight from leadership are necessary to foster accountability, ensure effective corrective actions, and manage supplier quality. Addressing these issues is vital for maintaining the integrity of the quality management system and ensuring accurate production processes.
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Conclusion In conclusion, it is important to acknowledge the positive aspects observed during the audit. The facility's exceptional cleanliness, a well-maintained EHS program with no violations, effective production controls, and the VP of Engineering's active engagement in Gemba Walks all contribute to a safe, efficient, and productive working environment. However, addressing the identified issues offers a valuable opportunity for the organization to further enhance its quality management systems and processes. By improving initiative and ownership, strengthening corrective actions, better managing suppliers, and ensuring compliance with customer requirements, the organization can maintain high standards. Proactive leadership and thorough oversight are essential for fostering accountability and continuous improvement. By taking these steps, the organization will uphold the integrity of its quality management system, ensuring reliable production processes and continued success.
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
Gaps in the Quality Manual
Category Checklist Questions
OQE to Request
Supplier Information
1. Does the supplier have a quality management system in place that meets the requirements of the applicable standards?
Can you describe how your quality management system meets the applicable standards?
No specific mention of how the quality management system meets applicable standards. No specific mention of the process for establishing and reviewing quality objectives. No specific mention of the process for continuous monitoring and review. No specific mention of the definition and communication of roles and responsibilities.
Section 4.1, Define how the quality management system meets applicable standards.
The supplier has a quality management system that meets the applicable standards.
Quality management system documentation
Section 4.1 General Requirements
General
Procedure P-001 Rev. A
Section 5.4, Define process for establishing and reviewing quality objectives.
How are quality objectives established and reviewed?
2. Are quality objectives established and reviewed regularly?
Quality objectives are established and reviewed regularly.
Records of quality objective reviews
Section 5.4 Quality Planning
General
Procedure P-002 Rev. B
What process is in place for continuous monitoring and review of the quality management system?
3. Is there a process for continuous monitoring and review of the quality management system? 4. Are roles, responsibilities, and authorities for quality management defined and communicated within the organization? 5. Is there evidence of management commitment to the implementation and improvement of the quality management system?
There is a process for continuous monitoring and review of the quality management system.
Quality management system monitoring and review records
Section 5.6, Define process for continuous monitoring and review.
Section 5.6 Management Review
General
Procedure P-003 Rev. C
How are roles, responsibilities, and authorities for quality management defined and communicated?
Roles, responsibilities, and authorities for quality management are defined and communicated.
Section 5.5 Responsibility, Authority, and Communication
Organization charts and role definitions
Section 5.5, Define and communicate roles and responsibilities.
General
Procedure P-004 Rev. D
Can you provide evidence of management's
Section 5.1, Provide evidence of management commitment to the quality management system.
There is evidence of management commitment to the quality management system.
No specific mention of management commitment to the quality management system.
Section 5.1 Management Commitment
Records of management review meetings
General
Procedure P-005 Rev. E
commitment to the quality management system?
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
Gaps in the Quality Manual
Category Checklist Questions
OQE to Request
Supplier Information
1. Are the applicable forms identified and controlled within the quality management system?
How are applicable forms identified and controlled within the quality management system?
The applicable forms are identified and controlled within the quality management system.
Section 7.5.3 Control of Documented Information
No specific mention of identification and control of applicable forms.
Section 7.5.3, Define identification and control of applicable forms.
Documented information control process
Applicable Forms
Procedure P-006 Rev. A
2. Are forms reviewed and approved before use to ensure they meet the intended requirements?
Forms are reviewed and approved before use to ensure they meet the intended requirements.
Section 7.5.3 Control of Documented Information
What is the process for reviewing and approving forms before use?
No specific mention of the process for reviewing and approving forms.
Section 7.5.3, Define process for reviewing and approving forms.
Records of form reviews and approvals
Applicable Forms
Procedure P-006 Rev. A
3. Are obsolete forms removed from points of use to prevent unintended use?
Section 7.5.3 Control of Documented Information
Obsolete forms are removed from points of use to prevent unintended use.
How do you ensure that obsolete forms are removed from points of use?
No specific mention of procedures for removing obsolete forms.
Section 7.5.3, Define procedures for removing obsolete forms.
Applicable Forms
Logs of obsolete forms removal
Procedure P-006 Rev. A
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Records 1. Is it stated in the supplier’s procedures that all OQE pertaining to supplied material must be retained for a period of 7 years after the completion of the last item of the
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Mandates the retention of all quality and compliance records for a minimum of 7 years to ensure traceability and accountability.
What are your procedures for retaining OQE for the required period?
Retention policies, sample retained documents
Lack of comprehensive retention procedures for OQE.
Refer to Section 7.5.3 of the Quality Manual. Implement and document procedures to ensure retention of OQE for the specified periods.
contract (purchase order) and shall be made available to the Purchaser within 36 hours upon request? For electronic parts and assemblies, this time of retention is extended to ten years. that test reports and/or other verification of conformance documents need to be signed and dated by the seller’s authorized representative? erasures or obliterations of information on Quality records are prohibited and that corrections must be made in ink by drawing a single line through the incorrect entry and be dated and initialed by authorized personnel? records made by the person who made the original entry, a supervisor, or person assigned by the supervisor? Is the original entry legible?
Records 2. Does the supplier understand
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Requires all critical documents, such as test reports and verification records, to be officially signed and dated by authorized personnel. Details the proper method for making corrections in quality records to maintain their integrity and traceability. Specifies that corrections to records must be made by authorized individuals and must maintain legibility to ensure traceability and integrity of records. Ensures all records are documented and annotated clearly and comprehensively to meet quality and regulatory requirements.
How do you manage and verify the signing and dating of test reports and
Signed test reports, verification documents
Inconsistent signing and dating of documents.
Refer to Section 7.5.3 of the Quality Manual. Ensure proper management and verification of document signing and dating. Refer to Section 7.5.3 of the Quality Manual. Implement and document procedures to ensure retention of OQE for the specified periods. Refer to Section 7.5.3 of the Quality Manual. Designate authorized personnel for record corrections and ensure the legibility of original entries. Refer to Section 7.5 of the Quality Manual. Establish
verification documents?
Records 3. Is the supplier aware that
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
What procedures are in place to handle corrections in quality records?
Corrected records samples, correction policy
Lack of clear procedures for correcting quality records.
Records 4. Are corrections to official
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Who is authorized to make corrections to official records, and how do you ensure the original entries remain legible?
Corrected records, policy on record amendments
Inconsistent authorization for making corrections. Inadequate documentation and annotation of official records.
Records 5. Are official records
Section 7.5 Documented Information
Procedure P- 022 Rev. E
How are official records documented and
Sample of annotated records, documentation guidelines
documented or annotated satisfactorily?
clear guidelines for documenting and annotating records satisfactorily.
reviewed for satisfactory annotation?
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Records 6. Are authorized personnel
Section 7.3 Awareness
Procedure P- 022 Rev. E
Requires that all personnel authorized to sign official records, such as NDT certifications, are clearly designated and documented. Stipulates that all documents must be dated with complete information to ensure proper tracking and historical accuracy. Mandates that any changes made to parts are reflected in updated Certificates of Conformance to maintain traceability and compliance. Requires systematic reviews of retention periods to ensure compliance with mandated timelines, especially for electronic records and cloud storage. Highlights the requirement to notify EB before the destruction of any records, ensuring regulatory compliance and historical integrity.
How do you designate and document authorized personnel for signing official records?
Authorization records, NDT certification records
Lack of documented authorization for personnel signing official records. Inaccurate or incomplete dating of documents.
Refer to Section 7.3 of the Quality Manual. Ensure all authorized personnel are designated in writing and documented. Refer to Section 7.5.3 of the Quality Manual. Implement and enforce a policy requiring full dating of all documents.
signing official records designated in writing by the supplier (including NDT certs)?
Records 7. Do vendor procedures state
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
How do you ensure that all documents are dated
Sample documents, dating policy
that documents must include the date, including month, date, and year?
accurately and in compliance with procedural requirements?
Records 8. Do vendor procedures state
Section 8.5.6 Control of Changes
Procedure P- 022 Rev. E
How do you manage the dating of Certificates of Conformance in relation to changes made to parts? How often do you review the retention periods for electronic records, and what is the process? What is the procedure for notifying EB before the destruction of records post-retention period?
Updated certificates, change management records
Lack of proper management of Certificates of Conformance.
Refer to Section 8.5.6 of the Quality Manual. Ensure all changes are reflected in updated Certificates of Conformance.
that a Certificate of Conformance must postdate any changes made to a part?
Records 9. Are retention periods for
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Retention policy, review logs
Inconsistent review of electronic record retention periods.
Refer to Section 7.5.3 of the Quality Manual. Regularly
electronic records (including cloud storage) reviewed to ensure that records are kept for 10 years for electronic parts and assemblies (seven years for other parts)?
review and document retention periods for electronic records.
Records 10. Is the vendor aware that
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Destruction policies, communication records
Lack of notification procedures before record destruction.
Refer to Section 7.5.3 of the Quality Manual. Implement procedures to notify EB before the destruction of any records.
even after the required retention period, EB must be notified before records are destroyed?
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 5.1 Leadership and Commitment
Related Procedure Name and Number Procedure P-022 Rev. E
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Malpractice Is there a division or company policy or statement on management’s position concerning malpractice? (EB TERMS AND CONDITIONS No. EB-2NC Non- Commercial par 8)
Highlights the leadership's commitment to preventing malpractice through clear policy communication.
What is your policy on malpractice, and how is it communicated and enforced within the organization?
Malpractice policy, training records
Lack of a clear policy or communication
Refer to Section 5.1 of the Quality Manual. Implement a clear policy on malpractice prevention and ensure it is well communicated throughout the organization.
strategy on malpractice prevention.
Malpractice 2. Do procedures specifically address malpractice prevention awareness as a condition of employment?
Section 5.1 Leadership and Commitment
Procedure P-022 Rev. E
The manual requires that all employees are made aware of the company’s stance on malpractice prevention as part of their employment condition. Describes the methods used to communicate key quality and compliance issues, including malpractice, to employees. Emphasizes the need for structured training programs for both new and existing employees that include education on malpractice prevention and consequences. Ensures that first-line supervisors are well-informed and understand the company’s stance on malpractice, reflecting management’s commitment to governance and ethical practices.
How do you ensure that employees are aware of malpractice prevention
Training records, employee
Inadequate training on malpractice prevention at the time of employment. Lack of communication tools or methods for informing employees about malpractice and its consequences. Inadequate training programs for new and existing employees on
Refer to Section 5.1 of the Quality Manual. Ensure that all employees are trained on malpractice prevention policies upon employment. Refer to Section 7.3 of the Quality Manual. Implement effective communication tools and methods to inform employees about malpractice. Refer to Section 7.2 and 7.3 of the Quality Manual. Implement comprehensive training programs that address malpractice prevention and consequences. Refer to Section 5.1 of the Quality Manual. Ensure that first- line supervisors are well-informed about management's position on malpractice and its consequences.
policies upon employment?
handbooks
Malpractice 3. Are letters to employees or
Section 7.3 Awareness
Procedure P-022 Rev. E
What tools and methods are used to communicate about malpractice to employees throughout the company? What does your training program for new and existing employees include regarding malpractice prevention and awareness?
Copies of letters and posters, communicatio n logs
posters utilized to inform personnel about malpractice and its consequences?
Malpractice 4. Does the division or company have a training program for new
Section 7.2 Competence, 7.3 Awareness
Procedure P-022 Rev. E
Training program outlines, records, training materials
employees and a refresher program for existing personnel which addresses malpractice?
attendance
malpractice prevention.
Malpractice 5. In your discussions with the
Section 5.1 Leadership and Commitment
Procedure P-022 Rev. E
How do first-line supervisors communicate and
Meeting minutes, internal communicatio ns, training
Lack of understanding among first-line supervisors about management's position on malpractice.
first line supervisors, do you feel that they are familiar with management’s position on malpractice and understand the consequences?
reinforce management’s position on malpractice to their teams?
session records.
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 8.5 Production and Service Provision
Related Procedure Name and Number Procedure P-022 Rev. E
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
General Workmanship/ Quality Practices
1. Does the supplier practice good workmanship habits with respect to product cleanliness? (i.e.: free from foreign objects, chips, burrs, construction debris, etc.)
Outlines the standards for workmanship, particularly the cleanliness of products during manufacturing.
How do you maintain and monitor cleanliness during production processes?
Cleanliness guidelines, inspection records
Inconsistent cleanliness practices during manufacturing.
Refer to Section 8.5 of the Quality Manual. Implement and document clear cleanliness guidelines for all stages of production.
General Workmanship/ Quality Practices
2. Does the supplier have a documented system for maintaining system/component cleanliness integrity?
Section 8.5.4 Preservation
Procedure P-022 Rev. E
Stresses the importance of maintaining the integrity of systems/components through adequate preservation measures.
What systems do you have in place to ensure the cleanliness and integrity of components throughout production? What is the procedure number for your cleanliness/flushing process, and how was it approved by the purchaser? How do you ensure compliance with the sample testing requirements? Who conducts the sampling and how?
Preservation and maintenance records
Lack of documented system for maintaining cleanliness and integrity of components.
Refer to Section 8.5.4 of the Quality Manual. Implement a documented system to ensure the cleanliness and integrity of components.
General Workmanship/ Quality Practices
3. Does the supplier have a Purchaser approved cleanliness/flushing procedure? If Yes, Procedure #:
Section 8.5 Production and Service Provision
Procedure P-022 Rev. E
Stipulates the requirement for specific cleanliness procedures to be approved by the purchaser, ensuring that all processes meet cleanliness standards. Ensures that sample testing is conducted in accordance with the approved procedures, whether in-house or by an external agency.
Approved procedure
Lack of approved
Refer to Section 8.5 of the Quality Manual. Ensure all cleanliness procedures are approved by the purchaser and documented.
cleanliness/flushing procedures.
documentatio n, approval records
General Workmanship/ Quality Practices
4. Does the supplier comply with sample testing requirements of the approved procedure? Is sampling done in-house or performed by an outside agency?
Section 8.6 Release of Products and Services
Procedure P-022 Rev. E
Sampling procedure
Inconsistent sample testing procedures.
Refer to Section 8.6 of the Quality Manual. Implement and document consistent sample testing procedures, whether done in-house or by an external agency.
documentatio n, contracts with external agencies
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 7.1.5 Monitoring and Measuring Resources
Related Procedure Name and Number Procedure P-022 Rev. E
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
General Workmanship/ Quality Practices
5. Does the supplier maintain cleanliness and provide for protection of test equipment?
Highlights the importance of maintaining cleanliness and protecting test equipment to ensure accuracy and reliability of measurements.
How do you maintain cleanliness and protect your test
Maintenance logs, cleanliness standards documentatio n Cleanliness logs, process documentatio n
Lack of maintenance and protection protocols for test equipment.
Refer to Section 7.1.5 of the Quality Manual. Implement and document protocols for maintaining cleanliness and protecting test equipment.
equipment from contamination or damage?
General Workmanship/ Quality Practices
6. Does the supplier maintain cleanliness during assembly, test, and packaging?
Section 8.5 Production and Service Provision
Procedure P-022 Rev. E
Requires maintaining cleanliness throughout all stages of production, including assembly, testing, and packaging, to prevent contamination. Mandates that the inspection department must verify the cleanliness of products before they are packaged and shipped to ensure quality control. Requires documentation and tracking of all materials, particularly post-processing such as heat treatment, to ensure traceability.
How is cleanliness maintained during assembly, testing, and packaging processes?
Inconsistent cleanliness practices during assembly, testing, and packaging. Lack of verification procedures for cleanliness before packaging and shipping.
Refer to Section 8.5 of the Quality Manual. Implement and document clear cleanliness practices during assembly, testing, and packaging. Refer to Section 8.6 of the Quality Manual. Implement and document verification procedures to ensure cleanliness before packaging and shipping. Refer to Section 8.5.2 of the Quality Manual. Ensure comprehensive documentation and tracking of material processing and traceability.
General Workmanship/ Quality Practices
7. Does the supplier’s inspection department verify cleanliness prior to packaging and shipping?
Section 8.6 Release of Products and Services
Procedure P-022 Rev. E
How does your inspection
Inspection reports, cleanliness
department verify cleanliness before packaging and shipping products?
verification
records
General Workmanship/ Quality Practices
8. Does the supplier’s material control system document when material is worked or heat treated, resulting in changes to mechanical properties and is it uniquely marked or re-identified to provide traceability to the final condition?
Section 8.5.2 Identification and Traceability
Procedure P-022 Rev. E
How is material processing documented and tracked within your control system?
Processing logs, material traceability records
Inadequate documentation and tracking of material processing.
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number Procedure P-006 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Records
1. Is there a documented process for the creation, maintenance, and disposition of records?
Section 7.5.3 Control of Documented Information
There is a documented process for the creation, maintenance, and disposition of records.
Can you describe the process for the creation, maintenance, and disposition of records?
Documented process for record creation, maintenance, and disposition
No specific mention of the process for record creation, maintenance, and disposition. No specific mention of ensuring records are legible, identifiable, and traceable. No specific mention of measures to protect records from damage, deterioration, or loss. No specific mention of defining and adhering to retention times. No specific mention of procedures for storing records to ensure retrievability.
Section 7.5.3, Define process for record creation, maintenance, and disposition.
Records
2. Are records legible, identifiable, and traceable to the relevant product?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are legible, identifiable, and traceable to the relevant product.
How do you ensure records are legible, identifiable, and traceable to the relevant product?
Sample records showing
Section 7.5.3, Ensure records are legible, identifiable, and traceable.
legibility, identification, and traceability
Records
3. Are records protected from damage, deterioration, or loss?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are protected from damage, deterioration, or loss.
What measures are in place to protect records from damage, deterioration, or loss? How are retention times for records defined and adhered to? How are records stored to ensure they are readily retrievable?
Records protection measures
Section 7.5.3, Implement measures to protect records from damage, deterioration, or loss.
documentatio n
Records
4. Are retention times for records defined and adhered to?
Section 7.5.3 Control of Documented Information Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Retention times for records are defined and adhered to.
Records retention schedule
Section 7.5.3, Define and adhere to retention times.
Records
5. Are records stored in a manner that ensures they are readily retrievable?
Procedure P-006 Rev. A
Records are stored in a manner that ensures they are readily retrievable.
Records storage procedures
Section 7.5.3, Store records to ensure retrievability.
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number Procedure P-006 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Records
6. Are electronic records backed up to prevent loss of data?
Section 7.5.3 Control of Documented Information
Electronic records are backed up to prevent loss of data.
What procedures are in place for backing up electronic records?
Electronic records backup logs
No specific mention of backing up electronic records.
Section 7.5.3, Backup electronic records.
Records
7. Are obsolete records clearly identified and properly disposed of?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Obsolete records are clearly identified and properly disposed of.
How are obsolete records identified and disposed of?
Logs of obsolete records disposal
No specific mention of identifying and disposing of obsolete records.
Section 7.5.3, Identify and dispose of obsolete records.
Records
8. Are records reviewed periodically to ensure they remain relevant and accurate?
Section 7.5.3 Control of Documented Information Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are reviewed periodically to ensure they remain relevant and accurate.
How often are records reviewed to ensure they remain relevant and accurate? What access controls are in place to prevent unauthorized changes to records? How do you ensure records are maintained in compliance with legal
Records review logs
No specific mention of periodic review of records.
Section 7.5.3, Periodically review records.
Records
9. Are access controls in place to prevent unauthorized changes to records?
Procedure P-006 Rev. A
Access controls are in place to prevent unauthorized changes to records.
Access control policies for records
No specific mention of access controls to prevent unauthorized changes. No specific mention of maintaining records in compliance with legal and regulatory requirements.
Section 7.5.3, Implement access controls to prevent unauthorized changes.
Records
10. Are records maintained in a manner that complies with applicable legal and regulatory requirements?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are maintained in compliance with applicable legal and regulatory requirements.
Compliance records with legal and regulatory requirements
Section 7.5.3, Maintain records in compliance with legal and regulatory requirements.
and regulatory requirements?
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Material
1. Is there a documented process for material identification and traceability?
Section 8.5.2 Identification and Traceability
Procedure P-010 Rev. B
There is a documented process for material identification and traceability.
Can you describe the process for material identification and traceability?
Material identification and traceability process documentatio n Records of material identification and traceability
No specific mention of the process for material identification and traceability.
Section 8.5.2, Define process for material identification and traceability.
Control and Identification
Material
2. Are materials identified and traceable throughout the production process?
Section 8.5.2 Identification and Traceability
Procedure P-010 Rev. B
Materials are identified and traceable throughout the production process.
How are materials identified and traceable throughout the production process?
No specific mention of identifying and tracing materials
Section 8.5.2, Identify and trace materials throughout production.
Control and Identification
throughout production.
Material
3. Are non-conforming materials clearly identified and segregated to prevent their use?
Section 8.7 Control of Nonconforming Outputs
Procedure P-011 Rev. C
Non-conforming materials are clearly identified and segregated to prevent their use.
How do you identify and segregate non- conforming materials?
Logs of non- conforming materials
No specific mention of identifying and segregating non- conforming materials.
Section 8.7, Identify and segregate non-conforming materials.
Control and Identification
Material
4. Is there a system for controlling and documenting the status of materials?
Section 8.5.2 Identification and Traceability
Procedure P-010 Rev. B
There is a system for controlling and documenting the status of materials.
What system do you use for controlling and documenting the status of materials?
Status control and documentatio n system records
No specific mention of a system
Section 8.5.2, Control and document material status.
Control and Identification
for controlling material status.
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Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 7.1.5 Monitoring and Measuring Resources Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.5.2 Identification and Traceability
Related Procedure Name and Number Procedure P-012 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Material
5. Are materials properly stored to prevent damage and deterioration?
Materials are properly stored to prevent damage and deterioration.
How are materials stored to prevent damage and deterioration?
Material storage procedures
No specific mention of procedures for material storage to prevent damage. No specific mention of ensuring only approved materials are used. No specific mention of maintaining records for material identification and traceability. No specific mention of audit program structure.
Section 7.1.5, Store materials to prevent damage.
Control and Identification
Material
6. Are there procedures in place to ensure that only approved materials are used?
Procedure P-013 Rev. D
Procedures are in place to ensure that only approved materials are used.
What procedures ensure that only approved materials are used?
Approved material usage procedures
Section 8.4, Ensure only approved materials are used.
Control and Identification
Material
7. Are records of material identification and traceability maintained?
Procedure P-010 Rev. B
Records of material identification and traceability are maintained.
How are records of material identification and traceability maintained?
Material identification and traceability records Internal audit program documentatio n
Section 8.5.2, Maintain records for material identification and traceability.
Control and Identification
Audits (Internal and When Required for Level I
1. Does the supplier maintain an internal audit program to verify that its quality system is being followed?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
The supplier maintains an internal audit program to ensure compliance with the quality system.
How is your internal audit program structured to verify compliance with the quality system? What criteria do you use to schedule internal audits?
Section 9.2, Define audit program structure.
Material, External)
Audits (Internal and When Required for Level I
2. Are internal audits scheduled based on the status and importance of the activity to be audited?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Audits are scheduled based on the status and importance of activities.
Audit schedules
No specific mention of audit scheduling criteria.
Section 9.2, Define audit scheduling criteria.
Material, External)
16
Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 10.2 Nonconformity and Corrective Action
Related Procedure Name and Number Procedure P-005 Rev. D
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Audits (Internal and When Required for Level I
3. Are corrective actions taken without undue delay after detection of nonconformance?
Corrective actions are promptly taken following the detection of nonconformances.
What is the process for implementing corrective actions after a nonconformance is detected? How are audit results documented and communicated to management?
Corrective action logs
No specific mention of corrective action implementation timeline.
Section 10.2, Define corrective action implementation timeline.
Material, External)
Audits (Internal and When Required for Level I
4. Are audit results documented and reported to responsible management?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Audit results are documented and reported to management for review.
Audit reports No specific mention of audit result documentation procedures.
Section 9.2, Define audit result documentation procedures.
Material, External)
Audits (Internal and When Required for Level I
5. Are re-audits conducted to verify the effectiveness of corrective actions taken?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Re-audits are conducted to ensure the effectiveness of corrective actions.
How do you verify the effectiveness of corrective actions through re-audits?
Re-audit reports
No specific mention of re-audit procedures.
Section 9.2, Define re-audit procedures.
Material, External)
Audits (Internal and When Required for Level I
6. Are auditors independent of the areas being audited to ensure objectivity?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Auditors are independent of the areas being audited to maintain objectivity.
How do you ensure the independence and objectivity of your auditors?
Auditor independence records
No specific mention of auditor independence assurance.
Section 9.2, Ensure auditor independence.
Material, External)
Audits (Internal and When Required for Level I
7. Are internal audit records maintained for an adequate period to support quality system reviews?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Internal audit records are kept for a sufficient period to support quality reviews.
How long are internal audit records maintained and how are they used in quality system reviews?
Internal audit records
No specific mention of record retention period for internal audits.
Section 9.2, Define record retention period for internal audits.
Material, External)
17
Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Level I
1. Is there a documented process for the identification and handling of Level I material?
Section 8.5.2 Identification and Traceability
Procedure P-014 Rev. A
There is a documented process for the identification and handling of Level I material.
Can you describe the process for the identification and handling of Level I material?
Identification and handling process documentatio n
No specific mention of the process for identification and handling of Level I material. No specific mention of identifying and segregating Level I materials.
Section 8.5.2, Define process for identification and handling of Level I material.
Material
Level I
2. Are Level I materials clearly identified and segregated from other materials?
Section 8.5.2 Identification and Traceability
Procedure P-014 Rev. A
Level I materials are clearly identified and segregated from other materials.
How are Level I materials identified and segregated from other materials?
Segregation logs for Level I materials
Section 8.5.2, Identify and segregate Level I materials.
Material
Level I
3. Are records maintained for the receipt, handling, and disposition of Level I material?
Section 8.5.2 Identification and Traceability
Procedure P-015 Rev. B
Records are maintained for the receipt, handling, and disposition of Level I material.
How do you maintain records for the receipt, handling, and disposition of Level I material?
Records of receipt, handling, and disposition of Level I material
No specific mention of maintaining records for Level I material.
Section 7.5.3, Maintain records for Level I material.
Material
Level I
4. Is there a process for the inspection and testing of Level I materials to ensure compliance with specifications?
Section 8.6 Release of Products and Services
Procedure P-016 Rev. C
There is a process for the inspection and testing of Level I materials to ensure compliance with specifications.
What is the process for the inspection and testing of Level I materials?
Inspection and testing reports for Level I materials
No specific mention of inspection and testing process for Level I materials.
Section 8.6, Define inspection and testing process for Level I materials.
Material
18
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