Audit

Quality Objectives (6.2)

Can you explain the pillar goals of the organization?

How does your department help the organization reach its goals?

Not every department will impact all of the pillar goals

Comments:

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.)

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

Is there documentation that states what corrective action will be taken if required training is not maintained?

Documentation:

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.

Communication (7.4)

How does the department communicate goals, information, changes, and grievances to team members?

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?

Are all documents maintained on the retention list (QSF-SRH-0003 Documented Information Master List)

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 are not blocked, O2 cylinders are secured when not in use, Bio-hazard containers are secured.

Notes:

Additional Process questions

Question

Question:

Answer:

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

This process is performed by an outside entity (Vendor or Contract Service).

Externally Provided Products and Services (8.4)

Has the outside entity been validated by the organization?

Contract evaluation, extension, or renewal can verify this

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:

Patient Property (8.5.3)

A patient's personal property may be involved

Can team members describe how property belonging to a patient is maintained while in the care of SRH?

Is there a policy/procedure that covers this?

Preservation of Products or Services (8.5.4)

Are products properly preserved according to applicable standards or regulations

Refrigerator Temps are within limits, Maintenance labels are up-to-date, Inspections are current

Comments:

Control of Nonconforming Outputs (8.7)

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

Describe the process:

Is there a process for handling customer complaints/grievances?

Explain this process:

Performance Evaluation (9)

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

How do you evaluate performance in order to achieve certain results?

Explain how the 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.

Do you share both 'wins' and 'areas needing improvement' with other departments who share similar goals or frustrations?

Improvement (10)

Is there a procedure for addressing staff grievances and complaints?

Documentation of process:

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.

Conclusion

After the audit is complete:

Enter any Nonconformity, OFIs and Noteworthy Efforts that were identified during the audit.

NC or Finding

Finding

Requirement that was not met:

Evidence that the requirement was not met:

Opportunities for Improvement

OFI

OFI:

Noteworthy Efforts

NE

NE:

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.