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
Training and Competence
1. Are employees trained for their specific job functions?
Globe QMS, Section 7.2
Globe Training Procedure, P-008
Employees must receive training tailored to their job roles, ensuring they have the necessary skills and knowledge. There should be a documented process to regularly evaluate the competence of employees to ensure ongoing compliance with required standards. Training records must be maintained, updated, and easily accessible for verification during audits or reviews. Training needs should be identified based on the job requirements and performance evaluations to ensure all employees are adequately trained. All new employees should receive an orientation and initial training to familiarize them with company policies, job responsibilities, and compliance requirements.
Can you describe the training you received for your job?
Training records and certifications
Ensure all roles are covered and training is regularly updated.
Review and update training processes in Procedure P-008 to cover all job roles.
Training and Competence
2. Is there a process for ongoing competency evaluation of employees?
Globe QMS, Section 7.2
Globe Competency Evaluation, P-008
How often is your competence evaluated, and what does the evaluation process involve? Where are your training records kept, and how can they be accessed?
Competency evaluation reports
Regular updates and consistent documentation of
Implement regular competency evaluations as outlined in Procedure P-008.
competency evaluations.
Training and Competence
3. Are training records maintained and easily accessible?
Globe QMS, Section 7.5
Globe Record Keeping, P- 008
Access to training records database
A centralized and accessible database for training records is necessary.
Establish a centralized database for training records as per Procedure P-008.
Training and Competence
4. Is there a process for identifying training needs based on job requirements and performance?
Globe QMS, Section 6.2
Globe Needs Analysis, P- 008
How are your training needs identified and addressed?
Training needs analysis reports
Regular review and update of training needs based on performance and job requirements. Comprehensive orientation and training program for new employees, with documented completion.
Conduct training needs analysis periodically as per Procedure P- 008.
Training and Competence
5.Are new employees provided with orientation and initial training?
Globe QMS, Section 7.3
Globe Orientation Program, P- 008
What was included in your orientation and initial training when you joined the company?
Orientation and initial training records
Follow the orientation and initial training guidelines in Procedure P-008.
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