Who's Who
A person qualified to conduct a QMS internal audit.
Who is a QMS auditor?
This is used to retroactively mitigate or eliminate process breakdown or variation.
What is a Corrective Action?
This can impact the way an auditor interprets a situation.
What is perception? (Also acceptable, what are past experiences, personal relationships, emotional sentiment regarding topic.)
The three phases of this process are: pre-audit planning, conducting the audit, and reporting and follow-up.
What is QMS auditing?
Records, data, statements of fact or other information which are relevant to the audit criteria.
What is audit evidence?
The acronym for Quality Management Oversight Committee
What is the QMOC?
Set of policies, procedures or requirements used as a reference against which audit evidence is compared.
What is audit criteria?
To eliminate all serious patient harm and achieve top decile quality care by December 31, 2020
What is Advocate Healthcare High Reliability Goal?
The international quality management system standard that provides a framework to drive operational excellence by integrating business objectives, accreditation efforts, quality initiatives and risk management activities.
What is ISO 9001?
The introduction used by the audit team to explain to auditees what is going to take place and answer any questions.
What is an Opening Session?
The associate who is asked/ answers the audit questions.
Who is the Auditee?
Product or process which doesn’t conform to requirements.
What is a Non-Conforming Product?
“Safety, Quality, and Service Always Through Continual Improvement.”
What is the Advocate Quality Policy?
Three examples of records at Advocate that need to be controlled.
What are (any three) Patient records, lab data, adverse event records, purchasing records, Imaging records, QMS Meeting minutes, training records, CAPAs, Completed forms?
An electronic system for managing Advocate's controlled documents, i.e., policies, procedures, etc.
What is the Advocate Document System?
This is the accrediting body for Advocate’s ISO 9001 certification. It is an international organization with a global reputation for quality and integrity in certification.
What/ who is DNV?
Action to eliminate the causes of potential nonconformities.
What is Preventive Action or Risk Assessment?
It is a framework for quality improvement through consistency of service, customer satisfaction and continual improvement. It is the foundation for high reliability and our Advocate Experience.
What is the Quality Management System?
Consistency (of delivery of service), Customer or Patient Satisfaction, and Continual Improvement?
What are the 3 fundamentals / 3 Cs of ISO 9001?
These are two desired qualities for QMS Auditors.
What is objectivity and integrity? (Can also be strong communication and listening skills, comfort with interviewing associates, interest and appreciation for principles of quality management/continual improvement, good documentation skills.
Someone who participates in at least 3 QMS audits can become one of these.
Who is a Lead QMS Auditor?
Allows us to "access the right document, with the right content, at the right time, in order to make the right decision."
What is Document Control?
Results of audits, process performance, and changes that could affect the QMS are just three of the inputs to this process.
What are inputs to Management Review/ QMOC
Three of the six specific ISO 9001 documented procedures which are foundational to Advocate’s QMS.
(any 3) What are Control of Documents * Control of Records * Control of Non-conforming Product * Internal Audits (or QMS Audits) * Corrective Action * Preventive Action?
These are 2 purposes of an audit.
What are (any 2) to confirm established goals and objectives are being met, to compare against established criteria or level of conformance, to establish a baseline, to identify opportunities for improvement/ process problems, to anticipate risks, determine effectiveness of a process, and to raise process knowledge?