Audit

Resources
Infrastructure (7.1.3)

Are there any tools, products, or equipment required for this process?
(Scanner, Insulated tools, imaging equipment, lasers, power tools, etc.)

Equipment requires inspection or calibration prior to use

Equipment/Device

Device

Is there an inspection/calibration sticker present?

Remove from service and contact BioMedical Services . Do not use until the equipment has an inspection/calibration completed.

Is today's date < 12 months from the sticker date?

Remove from service and contact BioMedical Services . Do not use until the equipment has an inspection/calibration completed.

Is the work area in suitable condition?

Location of finding:

Notify Facilities and/or management of issues found.

(Look for dirt, dust, noise, congestion, missing outlet covers, stained ceiling tiles, trip hazards, etc.)

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Comments:

Competency, Training, and Awareness (7.2)

Are there any certifications, licenses, or training requirements for team members who perform these tasks?

Team member HR file:

Team Member

Team member initials:

This team member is required to maintain a license or certification.

Is the team member's license/certification valid?

What steps are being taken to address the situation?

This team member is not required to maintain a license or certification to perform his/her job duties.

How does the department ensure that the team member has adequate experience or training for his/her position?

On-the-job (OTJ) experience/training can be considered adequate if there is a skills/competency evaluation.

Comments:

Orientation checklists, licenses, annual competencies, certifications can verify required training was completed

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Comments:

Policy (7.3)

Can you explain the SRH Quality Policy?

How do you and your department demonstrate the values of the Quality Policy?

(The Quality Policy is located on page 15 in the Quality Manual)

Explain the Preventive Maintenance schedule, according to department policy.

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Comments:

General Documentation Requirements (7.5)

Are there any documents are required for this process?
(Policies, Procedures, Forms, Electronic Maintenance Records)

Examples:

Are all required documents maintained on the Intranet (SharePoint)?

Review of Policies/Procedures

Policy/Procedure

[Date Ranges: Policies=3yrs, Forms=6yrs, External Documents: Annually, Order Sets= 2yrs (QSP-SRH-0001)]

Policy/Procedure Title and Number:

Formulated/Publish date:

Revision level:

Is the document compliant with review/revision dates?

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Comments:

Operation
Process Walk-through and Explanation

Summary of the process:

(This may require walking through a department or work area and may require PPE)

(Ensure fire extinguishers and electrical panels are not blocked, O2 cylinders are secured when not in use, Bio-hazard containers are secured.)

Notes:

Additional Process questions

Question

Question:

Answer:

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Customer Communication (8.2.1)

Is there a process for obtaining and responding to feedback from customers/patients?

(Customers may be other departments or team members)

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Externally Provided Products and Services (8.4)

Are any related operations performed by an outside entity (Vendor or Contract Service)?

Has the outside entity been validated by the organization?

(Contract evaluation, extension, or renewal can verify this)

Comments:

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Control of Production and Service Provision (8.5)

Are controls in place to verify that the intended outcome/result of this process is achieved?

Example:

(Examples are policies & procedures, protocols, order sets, forms, etc.)

Are there controls in place to prevent human error?

Example of control:

(Color coding, segregation, incompatibility of connectors, verification, etc. )

This process involves patient-related products (8.5.2)

(Patient-related products can be narcotics, implants, surgical sponges, etc.)

Is there a procedure for providing identification and traceability of patient-related products?

Explanation of process:

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Preservation of Products or Services (8.5.4)

Is test equipment currently within calibration date and specifications?

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Comments:

Control of Nonconforming Outputs (8.7)

Is there a process for addressing product failures (equipment, supplies, services)?

Describe the process:

What steps are taken when a piece of test equipment is found to be out of calibration specifications?

What actions are taken for equipment that was tested by out-of-calibration test equipment?

What is done when equipment cannot be located to perform preventive maintenance?

Is there a process for handling customer complaints/grievances?

Explain this process:

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Performance Evaluation (9)

Are there any defined department performance goals? (Yes or N/A)

Explain how any goals are set and measured:

If goals are not being met, what corrective actions are taken?

Are the results reported to higher levels for review?

Where are the results reported to?

(PIC, PEC, MEC, Board Review, Management Review, etc.)

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Improvement (10)

Are opportunities for improvement identified and addressed?

Example(s) or procedures:

Is feedback solicited from team members on how a task could be improved or streamlined?

Example(s) or methodology:

Suggestion box, leader engagement, idea board, etc.

Nonconformity

NC

Requirement that was not met:

Evidence that the requirement was not met:

Opportunity for Improvement

OFI

OFI:

Noteworthy Effort:

NE

Description of what it is the auditee is doing well

Conclusion

After the audit is complete:

Other Applicable Notes/Comments:

Auditor Name and Signature

Auditor

Name

Add signature
Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.