Guide to Quality Management
25 March 2008
Dr Ruth Standring-Cox
Aims of this session
To provide a basic guide to the requirements
for quality management under Human Tissue
Authority Directions 001/2006 and 002/2007
To cover practical examples of how some of the
key elements of a quality system can be put in
The total features and characteristics of a product
or service that bear upon it’s ability to satisfy a
Quality can be defined as “fitness for purpose”.
So be clear as to the purpose.
Knowing what you want to do
How you want to do it
Describing how you do it and who is
responsible NOT how you would like to do it.
Implementing systems to document and
improve the way you do it
Learning from what you do
Coordinated activities to direct and control an organisation
with regard to Quality
System – organisational
procedures, processes and
resources for implementing
management reviews of the
Improve the effectiveness
of the system.
Setting, maintaining and updating quality
objectives, establishing a quality policy.
Conducting regular reviews of the quality
Ensuring adequate resources are available.
Communicating the organisational structure to
Making staff aware of the importance of
ensuring the quality system is effective and
Appointing a Quality Manager.
The Quality Manager
Shall report to the
management on the
efficacy of the quality
Shall ensure that audit
and quality review are
Ensure personnel are
complying to the quality
Quality Management System
Policies, SOPs, Guidelines
Training and Reference Manuals
Records (including donor records)
Information on the final destination of tissues and cells
High level information on the structure of the
establishment and the approach to quality.
Overview of the Quality Management System.
Types of information to include:
Organisation and responsibilities
An outline structure of the system
Listing or reference to the location of policies and procedures
training and development
Outline of the evidence of Quality held by the establishment -
meetings minutes, training records, risk assessments.
SOPs for all processes that affect the
quality and safety of tissues / cells
Document and record control
Records should include traceability of tissues /
cells and all products and materials that have
come into contact with them
Audit and quality reviews
Assessment of risks.
Knowing what you do – an example
SLA with Environmental
Freezer Theatre Patient
Back up Alarm
Documenting Procedures (e.g. SOPs)
Know what you do
Document how you do it
Verify the documented procedure reflects what
Risk assessment – could include identified risks
Check that the documented procedure meets
Approval and issue.
Risk assessment – an example
Risk - loss of samples Donor Risk – cross contamination
• Lockable fridge Procurement of tissue • Segregation of each donor
• Clear procedures for all tasks
Tissue in sterile pots
Risk – using the wrong
Risk – using beyond
• Unique reference Patient • Do not use after date labels
• All samples from same
• Procedure for disposal
donor kept together
• Written receipt, testing and
Control, review and update
Documented system for controlling distribution
and managing versions.
SOP review dates must be specified and
reviews carried out by designated owners.
Audits help identify inconsistencies and may
lead to updates.
When the process changes re-assess the risks
and update the SOP to reflect the new
SOPs, Document and Record Control
Procedure for control of records
Records need to be
traceable and maintained for:
30 years post transplant
10 years for raw data
Document control system
this could be:
spreadsheet + controlled
Audit and Quality Reviews
Establish an annual audit plan for the quality
Decisions and corrective and preventive actions
documented and implemented
Review the performance of the quality system
to ensure continual improvement
Quality review includes serious adverse events
and reactions – system for identification,
investigation, control, recording and notification.
Audit of records
Can you easily trace a batch of tissues from
receipt to patient records?
Traceability – what has gone wrong?
bone batch C
A and B
Record receipt of Use batches A, B
batches A and B Transfer batches
and C in
in freezer log A and B to
book hospital theatre
Record transfer of Log use of
Store batches A Log use of
batches A and B to batches A, B and
and B in hospital batches A and C
hospital theatre in C in theatre
dedicated freezer freezer log book
in patient records
Records should include data necessary to
ensure that tissues / cells (which are procured,
processed, stored and / or distributed) can be
traced back to the recipient and vice versa.
Traceability applies to all products and
materials that come in contact with tissue/cells.
Adverse event, reaction or deviation from quality and
Should be carried out on critical processes
to ensure they are reproducible.
In particular quality critical processes such
storage (how long can you actually store tissue in
Should be documented.
Includes databases storing data.
Staff and Training
Staff are appropriately qualified and received
Training programme for staff in place and
Appropriate staff receive training in quality
Continuing professional development
Training records in place.
Quality Management System
Organisational structure and
Procedures and processes
Document and record control
Resources for implementing
Audit – traceability
Regular management reviews