BB 2: Compliance, QC, QA, QMS, PBM

what term refers to rules (standards, regulations, or an organization’s requirement) that govern us in making both a present and future decision?

policies

what term refers “what we do” and describes a specific work goal and defines “what” is done and “who” does it with large and more complicated activities?

processes

what term refers to “how we do things”and is a document that describes a series of tasks/steps that are required to complete one (1) piece of work/work instructions?

procedures

based on _____, sharing protected health information (PHI) is permitted only for the purposes of diagnosis, treatment, payment, or for lab operations and the release of PHI must be tracked.

HIPAA

what refers to the process/procedure that is performed to ensure the reagent and equipment are functioning properly according to manufacturer’s specifications?

QC

the process/procedure of ____ involves

• daily testing of all reagents

• daily or periodic checks (monthly, quarterly, semi-annual, annual) of calibration, monitoring, start-up functions, etc. on equipment

QC

what refers to a set of planned actions that ensures that all systems and elements that influence the quality of the testing or service are working as expected both individually and collectively?

QA

____ addresses how well the whole entire process of systems and elements are functioning.

QA

how many continuing education units are required per year?

12

what type of quality assessment could be used before being placed in use reagents are tested for sensitivity and specificity?

parallel testing

which phase of equipment validation often is the manufacturer’s responsibility?

design qualification

which phase of equipment validation is to ensure the installation met all manufacturer’s requirements to operate the equipment?

installation qualification

which phase of equipment validation is to ensure the equipment operates within the manufacturer’s stated limits, test for equipment failure, test for worst case scenarios (other than normal operating conditions)?

operational qualification

which phase of equipment validation is to ensure equipment processing is consistent, producing acceptable results under normal operating conditions?

performance qualification

SOPs are the same as policies. true or false?

false

what refers to a set of activities that ensures a given process will keep operating in a state that is continuously able to meet process goals without compromising the process itself?

process control

the following describes ____

• flowchart process

• identify procedures

• draft SOPs

• validate process

• finalize SOPs

• train/assess competence

• monitor process

process control

what provides internal staff and external inspectors with a clear idea of how objectives are accomplished?

documents

what results from capturing data or outcomes of activities from testing onto written form or electronic media?

records

what level of documentation refers to

• policies, time independent—mission statement

• what will be done

• rules !

I

what level of documentation refers to

• processes, shows flow of information

• how it happens

II

what level of documentation refers to

• procedures (SOPs)

• how to do it

III

what level of documentation refers to

• forms, records, supporting documents/data, QC records, templates

  • completed when you are performing the procedures and following the processes and policies

• supporting documents

• provide evidence of SOP performance

• blank forms

IV

what level of documentation is at the bottom of the pyramid as it is the most used?

IV

only select facilities require a process for document development, management, review, revision, archiving, and storage. true or false?

false

if it is not documented, it never happened. true or false?

true

if you make a mistake, it is common practice to completely cross out/obliterate or white-out the original data. true or false?

false

which educational action to correct nonconformance or error management refers to activities taken to alleviate the symptoms of a problem?

remedial action

which educational action to correct nonconformance or error management refers to activities taken to eliminate the cause of an existing problem?

corrective action

which educational action to correct nonconformance or error management refers to activities taken to prevent a potential problem?

preventative action

what plan refers to using both corrective and preventative action to show remedy and prevention of an error and is the preferred system means?

CAPA plan

which FDA class refers to the potential to cause serious injury or death?

I

which FDA class refers to the potential to cause temporary or less serious health problems?

II

which FDA class refers to the unlikelihood to cause harm but still violates FDA regulations?

III

what is the most common audit citation/finding?

failure to follow SOPs