Non-conformances / Document

Control
Dr A A Khine
Chemical Pathology
NHLS TYGERBERG
Lab Management Workshop
June 4-6 2019
Non-conformance in medical laboratory
• A failure to conform to accepted standards or SOP
• Non-conformance analysis involves the recognition of
deviations, recording immediate corrective action, finding
root causes and implementing preventive action.
• Critical component of quality policy and included in quality
manual
• This is part of (ISO) 15189:2012, thus laboratory accreditation
 Major:
NCs that pose immediate or imminent danger in patient care
Minor:
no direct effect on patient care or no immediate or imminent
danger but in long term may pose indirect danger to patients or
business

Give examples
Where and Why do NCs occur?

Machines Breakdowns
Out of
Preparation Reagents and stock
centrifugation consumables Expiries
Contamina
tions
Loss
Lack of training
Lack of discipline
Managers
SOPs Lack of monitoring
LSS QC
Operators
Lack of clarity
Lack of
consequences

Samples Reporting

customers
 How NCs are picked up
1. Checking – who is checking?
– After checking and finding something wrong, do
you report it? Does everyone report it?
2. Reporting- who is reporting?
– Incidence reporting
– Complaint reporting
– Audit reporting
3. NC in a process -> who was involved?
4. Reporting a NC or reporting a person? Can
we separate them?
 Closure of NC
• Who must close it?
• How to close it?
– Complete the NHLS NC form
– All 3 sections (identification and description of NC,
CA, RTA, PA)
– Monitoring of PA ???
Sample non-conformance Form
NON-CONFORMANCE
REPORT

Branch: NCR #: _________________

Laboratory:

Department: Dept Representative: Auditor:

Requirement/ Clause No: SANAS F88-03: SANAS F95-02: NCR Rating: Major Minor

Details of Non-conformance:

Signed: Date: Signed:

(Auditor) (Dept Representative)

Corrective action/s agreed:-

Target date for completion: ___ / ___ / ____ Actual date completed: ___ / ____ / _______

Signed: ____________________ Signed: ___________________

(Lab Supervisor) (Lab Supervisor)
Root cause analysis (discussed and agreed):-

The above finding was most likely a result of a deficiency in the area indicated below; and preventative action/s
must be directed to this area:-

Staff Training Document control

Equipment- scheduling of service/ maintenance Records/ Traceability
Written procedures Other ……………………………………..

(Where applicable) Preventive action/s agreed:

Target date: ___ / ____ / ______

Signed: __________________________
(Lab Supervisor)

Actual date completed: ___ / ___ / _____

Signed: ___________________________
(Lab Supervisor)

NCR Close out date: ___ / ___ / _____ Effective: Y N Signed: ____________________________
(Auditor)

Reported at Management Review: ___ /___ / ______ Signed: ____________________________

(Quality Manager)
 Corrective Action Process

CA - Action taken immediately or as soon as possible to correct the

NCs as they occur

RTA - Investigate what happened– root cause analysis

PA - Eliminate root cause so it won’t recur

NC

Monitor CA

Closing NC- within 25 days RTA

PA
 CAPA process is a cycle
1. Define what will be considered as NC and what is major and what
is minor (problems/errors/deviations)
2. Major or minor (consult with pathologists re: impact on patient)
3. Define CA for each NC (do this when that happens- as far as one
can predict) as it may require fast response
1. Establish a system (or tools) to identify NCs (must be in a SOP)
2. Register all NCs either manually in log books or electronically using standard form
3. Complete the CA taken and discuss with relevant parties involved if CA was appropriate
and adequate or not
4. Investigate root cause(s)- many times multiple causes- analyze information thoroughly
and without BIAS
5. Provide feedback to staff involved in NC
6. Discuss PA with staff for implementation
7. Observe for recurring problem. If recur, CA and look for root causes why
8. Review all NCs logged annually or bi-annually
9. Redefine NCs
10.Adjust CAPA
11.Staff feedback
 Root causes analysis
• Analysis of cause and effect
Ishikawa diagrams
 Trend analysis: Internal audits
Periodic examination of non-conformances to find and
document repeated non-conformances

Improvement goals: departmental and personal KPI

# of NCs (# major and minor) and # repeats

Annual accreditation visits- expect all NCs from internal audits

have been closed and CAPA implemented
Audit of NCs and impact
 Exercise
• There was persistent negative bias in your BNP and
Troponin I EQAs. Please help the bench supervisor
and lab manager to close this NC.

• You are a regional pathologist in the NHLS. The

rejection rate for serum K due to various reasons
was 20% at the referral provincial lab and 15% for
the local labs in average. Write up a plan in how you
would investigate this problem and close the NC.
DOCUMENT CONTROL
 Document control
• One of essential elements of
quality system
• One of the standards required
and checked during
accreditation
 What is document control?
• Document control is all to do with transferring information
between relevant parties.
• This could be a law firm sending a report to a client, a construction
firm receiving technical drawings from a designer, or a bakery
giving an employee a recipe to follow.
• We need to ensure that the information that reaches the end user
is correct, therefore the document must be controlled to ensure
that this is the case.
• Sometimes the information contained in a document needs to be
altered
• Placing controls on a document means that we ensure that the
document always contains the correct information
 Documents vs records
Documents Records
 Written policies, process  Collected information
descriptions, procedures captured on worksheets,
 Communicate information forms, labels and charts
 Need to be updated  Need to be easily retrieved
 Templates/blank forms and accessed
 Communicate information.  Raw data – instrument

Living documents which can No changes can be made to

be changed and updated. any records. They are the
history of actual events.
 Documents are the communicators of the
quality management system
Verbal instructions often are:

• not heard
• misunderstood
• quickly forgotten
• difficult to follow
 What makes a good document?
• Written clearly and concisely
• User-friendly style
• Explicit and accurate
• Maintained to stay up to date
• Accessible to all staff
Documents are a reflection of the
laboratory’s organisation and its
quality management.

A good rule to follow is:

“Do what you wrote and write what
you are doing.”
 Policy
- Statements of intentions
– National policies
– (all labs within NHLS shall participate in PT scheme, all staff of NHLS
shall work from 8 am to 5pm and 40 or 56 hours per week depending
on their category, registrars shall complete their training within 4-6
years)
– Lab specific policies (this laboratory runs in 3 shifts, all staff of this
laboratory shall participate in CPD activity once a week)
– defined by those in the organization and endorsed by management
– Aligned to organizational vision (what is envisaged) and mission (set
goals to get there)
– Each policy fulfils the goal or part of the goal in the mission
 Process and Procedure
Process:
Steps involved in carrying out policies
 A process is a series of related tasks or methods that together turn
inputs into outputs. (example: disciplinary action, registrar training,
lab accreditation etc.)
 A procedure is a prescribed way of undertaking a process or part of a
process.

A procedure describes: (SOP)

– Who is responsible for each part of the process
– When each part of the process occurs
– The specifications applicable to each part of the process
 Quality Manual
• Overall guiding document and compilation of quality
processes in pre-A, A, Post-A processes (TQM)
• Requirement of ISO 15189
• Clearly communicates information – internally & externally
• Serves as a framework or roadmap for meeting quality
management system
• Demonstrates management’s commitment to quality
• Kept up to date- always being improved
• Read, understood and followed by EVERYONE
 Generic template of SOP
 Author
 Reviewer
 Approver
 Scope
 Background and introduction
 Purpose or Objective
 Clinical Relevance
 Responsibility (who must do and who must monitor)
 Step by step procedure (if testing, starts with assay principle)-
this can be copied from package insert
 References
 Distribution list
 Controlling Documents
• Update so that what is in the document reflects the current
practise

• Ensure that most up to date version in use (Archive old

versions)

• Ensure availability (all staff must have access to Qpulse)

 Common problems
• Outdated document in circulation

• Distribution problems

• Failure to account for documents of external origin

 Scenario

You have found all these papers lying on a desk.

Which of these are documents and which are
records? Tick the “D” and circle the “R”.
• testing algorithm • report of corrective actions
• safety manual • temperature log (blank form)
• client test results • quality control record (blank form)
• standard operation procedures • daily maintenance log (completed)
(SOPs) for an approved HIV rapid • stock cards and stock book
test (completed)
• manufacturer test kit inserts • EQA sample transfer log
• summary of findings from on-site (completed)
evaluation visit
 Exercise
• You changed the dilution protocol of serum
and urine IFE.
• Show how you will implement this change in
the document control.
 Scenario

You have found all these papers lying on a desk.

Which of these are documents and which are
records?
• testing algorithm
• safety manual
• client test results
• standard operation procedures
(SOPs) for an approved HIV rapid
test
• manufacturer test kit inserts
• summary of findings from on-site
evaluation visit
• report of corrective actions
• temperature log (blank form)
• quality control record (blank form)
• daily maintenance log (completed)
• stock cards and stock book
(completed)
• EQA sample transfer log
(completed)
 Summary
• Documents:
– include written policies, processes, and procedures
– need to be updated and maintained
• Records:
– include information captured in processes
– are permanent, do not require updating
• A good document control program:
– most current version used
– availability and ease of access