[RFE COPY] EB2678 ISA Audit Preparation Gap Analysis_Globe

Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20

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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