QA- lec 8

Question 1

What is an audit

Answer 1

• A key tool in maintaining standards and quality improvements
• A part of the overall QA system
• Allows determination of compliance with
  
  • cGXP
  • Legal requirements
  • License commitments

Question 2

Audit versus research

Answer 2

• Some characteristics of the audit are similar to research, but the audit is not research
• Research
  
  • Creates and tests a new hypotheses
• Audit
  
  • Reviews standards to improve the quality of care
  • E.g. only giving certain anti-biotics for certain conditions- then checking those antibiotics are working well

Question 3

The beginnings of Audit (1)

Answer 3

• Government white paper
• Working for patients 1989
• An effective programme of the audit will help to provide, the necessary re-assurance to doctors, patients and managers that the best quality of service is being achieved within the recourses available

Question 4

The beginning of Audit (2)

Answer 4

• Moving towards Audit 1993
  
  • An education package for pharmacists
• Pharmaceutical quality standards
  
  • Hospital self-assessment standards
• Health Service Executive Letter
  
  • EL (96)95 and EL(97)52
  • Audit report form and checklist
  • Audit as the driving force to quality improvement

Question 5

Pharmacy contract

Answer 5

• Each community pharmacy needs to participate in at least 2 audits per year
• Pharmaceutical journal 13 August

Question 6

Audit

Answer 6

• The audit is about taking notes of what we do, learning from it and changing if necessary
• The audit should be a continuing process
• Driving force to quality improvement
• Started off as manufacturing
• Moving to improve care/outcomes of patients

Question 7

The Audit Cycle

Answer 7

• Audit Planning and Design => Set standards
• => Collect data
• => Evaluate the performance =>
• => Make changes
• => Monitor the effects of change

Question 8

Cycle audit planning and design

Answer 8

• How to start
• Topic
• Audit design
• How to finish- feedback about improvements and acheivments
  *

Question 9

What topic to audit

Answer 9

• High risk- Aseptic production
• High-volume- Over labelling
• Local issues- Needle exchange
• Targets- repeat Rx’s
• Area’s of concern- unique to place
• Area’s using large resource- Chemotherapy
• Pharmacy contract-

Question 10

Topic examples- clinical Audit

Answer 10

• New audit toolkits
  
  • Smoking cessation
• Archive templates
  
  • Patient counselling audit
  • Repeat prescribing
  • Audit Protocol for advice on asthma device technique
• Look as RPS site for more

Question 11

Topic examples- Production Audit

Answer 11

• Production processes
  
  • Documentation
  • Training
  • Environment
• Orange guide chapters

Question 12

Cycle: Set standards

Answer 12

• Standards should be SMART
• Specific
• Measurable
• Acheivable
• Realistic
• Timed

Question 13

Stadards should also be

Answer 13

• Driving force for improvement in standards of service and outcomes for patients
  
  • Best practise
  • Benchmark
• Desirable
• Agreed

Question 14

Advice on asthma technique (MDI)

Answer 14

• 60% wash the device according to manufacturers instructions
• 90% Do not regularly test the device
• 75% rinse their mouth after using an inhalation device for an inhaled steroid
• 90% able to demonstrate how to use the device correctly

Question 15

Repeat dispensing audit

Answer 15

• Criteria and standards should reflect national and local targets and accepted by the team
• These standards should then be agreed by the team
• Agree suitable means of collecting this data

Question 16

Repeat dispensing audit

Answer 16

• This is a large topic- split into small sections and audit these areas
• Functional
  
  • Who does what, when, how, time, checks
• Administration
  
  • Documentation
• Clinical
  
  • ADR reports, drug interactions, medication reviews, compliance, missing or ambiguous directions
• Make sure you stick to smart targets
• Requests for repeat prescriptions will be processed promptly
• 90% of requests for repeat Rx’s will be processed within 24 hours of request

Question 17

Collect data

What is actually happening

Answer 17

• Collect only the data required
  
  • Dont get carried away and collect to much data
  • Concentrate on answering the audit questions
• Keep data collection as simple as possible
• Make sure the time and place are suitable for participants
• Allow time for questions and discussion

Question 18

Evaluate performance

Answer 18

• Compare what should be and what is happening
• Was the information complete and accurate
  
  • Was it all collected during busy periods
  • Did anything exceptional happen during the audit: Staff sickness; locum cover

Question 19

Make changes

Answer 19

• Consider if standards have been met
• Identify cause(s) of non-compliance
• Agree on changes to be made
• Ownership of the audit is vital
  
  • If practice change is required, participants must be able to see why otherwise committed to the changes will not occur

Question 20

Monitor effect of changes

Answer 20

• This where the cycle continues
• Evaluate the success of change
• Re-measure the performance against standards
• The audit cycle starts again

Question 21

Why Audit

Answer 21

• Maintain standards
• Benchmarking
• Measurement of improvement
• Sanity check
• Identity weakness and strengths
• Build confidence in QA systems
• Assess risk to patients

Question 22

Why audit

Answer 22

• Because it is required by GXP
• Shows the regulators you meet appropriate standards
• Improve standards of service (where appropriate)
• Improve outcome for patients
• Self-inspections should be conducted to monitor the implementation of GMP
• Pharmacy contract

Question 23

Audit types summary

Answer 23

• Third party
• Second party
• First party
• Horizontal
• Vertical

Question 24

Third party

Audit types

Answer 24

• Undertaken by staff not managerially accountable within the corporate structure independent of any service provider to the unit
• A regulatory Audit
• For manufactures= MHRA
• For pharmacies= GPHC
• Can be commissioned by a company for a third party to audit a supplier or subcontractors

Question 25

Second party audit

Audit types

Answer 25

• When a company perfoms an audit of a supplier to ensure that they are meeting the requirements specified in the contract

Question 26

First party Audit

Audit types

Answer 26

• Internal self-inspection
• Conducted in an independent and detailed way by designated competent persons from within the company
• Monitors the implementation and compliance with GMP principles and to propose necessary corrective measures

Question 27

Audit approach

Answer 27

• There are 2 general approaches to audit
• Horizontal audit
  
  • Follow a process through- e.g. from raw material receipt, through production to finished product release
  • A good way to get a feel for the site and its problems
• Vertical Audit
  
  • Focus deeper into a specific area or topic for example adverse incident, complaints recalls
  • Can be time-consuming
  • You need to know when to stop