Information

  • Audit Subject:

  • Department or Service:

  • Location

  • Location

  • Conducted on

  • Audited By:

  • Team Members Present:

  • Participant
  • Attendee:

  • Position or Title:

  • QSF-SRH-0007, Rev 1.

Resources

Infrastructure (7.1.3)

  • Are there any tools, products, or equipment required for this process?<br>(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?<br>

  • 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?<br>(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? <br>

  • (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?<br>

  • (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?<br>

  • 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

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