C 41552: Quality Management

Part 2: LABORATORY
MANAGEMENT
Day 05

N.M.M. Jayamanne, MISM (UOC), B.Sc. (UOC)

Assistant Director, SLAB
Team Leader / Assessor ISO/IEC 17025:2017
 Wrap Up
 Last week we studied about
 Process requirements
 Sampling
 Handling of test/calibration items
 Technical records
 Evaluation of measurement uncertainty
Take home question:
 Consider following repeatability measurements of a analytical balance taken for
calculate repeatability uncertainty:
5.1, 5.0, 5.3, 4.8, 4.9, 5.1, 5.2, 5.4, 4.8, 4.2, 5.0, 5.0, 4.9, 5.1, 5.0

 Calculate mean:
 Calculate mode:
 Calculate median:
 Calculate standard deviation:
 What is the repeatability uncertainty range:
Take home question:
 ENSURING VALIDITY OF RESULTS

The laboratory shall have a procedure for monitoring the validity of results.
The resulting data shall be recorded in such a way that trends are
detectable and, where practicable, statistical techniques shall be applied to
review the results.

This covers Quality Control and Quality Assurance

of the laboratory
ENSURING VALIDITY OF TEST RESULTS
 METHODS

• Use of reference materials or quality control materials

• Use of alternative instrumentation that has been calibrated to provide
traceable results
• Functional check(s) of measuring and testing equipment
• Use of check or working standards with control charts, where applicable
• Intermediate checks on measuring equipment
• Replicate tests or calibrations using the same or different methods
 METHODS

• Replicate tests or calibrations using the same or different methods

• Retesting or recalibration of retained items
• Correlation of results for different characteristics of an item
• Review of reported results
• Intra-laboratory comparisons
• Testing of blind sample(s)
CONTROL CHARTS
CONTROL CHARTS
WESTGARD RULES
WESTGARD RULES
WESTGARD RULES
WESTGARD RULES
WESTGARD RULES
 EXTERNAL METHODS

• Proficiency testing
• Inter laboratory comparisons other than proficiency testing.
 INTER LABORATORY COMPARISONS
Lab A Lab A
Analysis of results

Lab B Lab B

Lab C Lab C

Series of identical samples

(Stability & Homogeneity) Lab D Lab D

Lab E Lab E

Receive samples Acceptability of results

Submit results

Comparison of results of different laboratories.

 INTER LABORATORY COMPARISONS
Lab A Lab A
Analysis of results

Lab B Lab B

Lab C Lab C

Series of identical samples

(Stability & Homogeneity) Lab D Lab D

PT PROVIDER Lab E PT PROVIDER Lab E

INDEPENDEDNT INDEPENDEDNT
Receive samples Acceptability of results
Submit results

REFEREAL LAB
ASSIGNED VALUE
 REPORTING OF RESULTS

• Results shall be reviewed and authorized prior to release

Authorized Signatory

• Results shall be provided

Accurately, Clearly, Unambiguously and Objectively
In a report

• Can Simplify reports

 TEST REPORT – BASIC REQUIREMENTS

• Title
• Name and address of the laboratory
• Location of performance of the laboratory activities
• Unique identification that all its components are recognized as a portion of a
complete report and a clear identification of the end
• Name and contact information of the customer
• Identification of the method used
• Description, unambiguous identification, and, when necessary, the condition
of the item
 TEST REPORT – BASIC REQUIREMENTS

• Date of receipt of the test or calibration item(s), and the date of sampling
• Date(s) of performance of the laboratory activity
• Date of issue of the report
• Reference to the sampling plan and sampling method
• Statement to the effect that the results relate only to the items tested,
calibrated or sampled
• Results with, where appropriate, the units of measurement
• Additions to, deviations, or exclusions from the method
 TEST REPORT – BASIC REQUIREMENTS

• Identification of the person(s) authorizing the report

• Clear identification when results are from external providers
 TEST REPORT – SPECIFIC REQUIREMENTS

• Information on specific test conditions, such as environmental conditions

• Where relevant, a statement of conformity with requirements or
specifications
• Where applicable, the measurement uncertainty
• Where appropriate, opinions and interpretations (
• Additional information that may be required by specific methods, authorities,
customers or groups of customers.
 CALIBRATION REPORT – SPECIFIC
REQUIREMENTS
• Measurement uncertainty
• Conditions (e.g. environmental) under which the calibrations were made that
have an influence on the measurement results
• Statement identifying how the measurements are metrologically traceable
• Results before and after any adjustment or repair, if available
• Where relevant, a statement of conformity with requirements or specifications
• Where appropriate, opinions and interpretations
• Calibration certificate or calibration label shall not contain any recommendation
on the calibration interval, except where this has been agreed with the customer.
 REPORTING SAMPLING

• Date of sampling
• Unique identification of the item or material sampled
• Location of sampling, including any diagrams, sketches or photographs
• reference to the sampling plan and sampling method
• Details of any environmental conditions during sampling
• Information required to evaluate measurement uncertainty for subsequent
testing or calibration.
 REPORTING STATEMENT OF CONFORMITY

• Document the decision rule

• The laboratory shall report on the statement of conformity, such that the
statement clearly identifies:
• to which results the statement of conformity applies
• which specifications, standards or parts thereof are met or not met
• the decision rule applied
 STATEMENT OF CONFORMITY
5.4

• Compliance to a requirement 5.3

Not Acceptable

• Yes / No 5.2

• Pass / Fail 5.1

5
Not Acceptable
4.9
????
4.8 Acceptable
4.7
????
4.6
Acceptable
What if uncertainty is considered? 4.5

Eg: Uncertainty ±2 4.4

Decision rule to be employed

 OPINIONS AND INTERPRETATIONS

Statements to describe/interpret on the results

Eg: Environmental noise level high in a particular area

Interpretation:
• Feast of the nearest Hindu temple may have affected the background noise.
REPORTING OPINIONS AND INTERPRETATIONS

• Only personnel authorized for the expression of opinions and

interpretations release the respective statement
• Laboratory shall document the basis upon which the opinions and
interpretations have been made.
• Shall be based on the results obtained from the tested or calibrated item
and shall be clearly identified as such.
• When opinions and interpretations are directly communicated by dialogue
with the customer, a record of the dialogue shall be retained.
 AMENDMENTS TO REPORTS

• When an issued report needs to be changed, amended or re-issued, any

change of information shall be clearly identified and, where appropriate,
the reason for the change included in the report.
• Amendments to a report after issue shall be made only in the form of a
further document, or data transfer, which includes the statement
“Amendment to Report, serial number... [or as otherwise identified]”, or an
equivalent form of wording.
 NON CONFORMING WORK
What they are?
 Any non-conformity / non-compliance observed
 Malfunctioning equipment
 Erroneous record
 Unacceptable environmental condition
 Improper testing practice
 Error in procedure…..
IDENTIFICATION OF NON
CONFORMITIES
External sources
 External audits
 Customer complaints
 Customer feedback

Internal sources
 Internal audits
 Incidents identified in day-to-day operations

Records of nonconforming work
shall retain in the laboratory.
If there is a possibility to recur
the NC, take suitable corrective
action
NON CONFORMING
WORK
Procedure:
 Responsibilities and authorities for management of
NCs
 Actions based upon the risk levels
 halting or repeating of work
 withholding of reports
 Evaluate significance of the nonconforming work
 Decision on the acceptability of NC
 Where necessary, the customer is notified and work
is recalled
 Responsibility for authorizing the resumption of work
 COMPLAINTS

Documented process to receive, evaluate and make decisions on

complaints.

Handling process for complaints shall be available to any interested party on

request.

Upon receipt of a complaint, the laboratory shall confirm whether the

complaint relates to laboratory activities that it is responsible for and, if so,
shall deal with it.
 COMPLAINTS

Process shall include:

• Description of the process for receiving, validating, investigating the
complaint, and deciding what actions are to be taken in response to it
• Tracking and recording complaints, including actions undertaken to
resolve them
• Ensuring that any appropriate action is taken.
 COMPLAINTS

Complaint
Gathering Communicate
Receive Acknowledge resolution & End of the
necessary outcomes to
Complaint receipt necessary complaint
information customer
actions
 CONTROL OF DATA AND INFORMATION
MANAGEMENT
The laboratory shall have access to the data and information needed to perform
laboratory activities.

DATA vs INFORMATION

What are they?

Test measurements, Calculation results, non—conformities, corrective actions,
risk analysis, etc
 LIMS
Use for collection, processing, recording, reporting, storage or retrieval of data
Validate for functionality

Commercial off-the-shelf software - authorized, documented and validated

before implementation.

How do you validate a software?

Is LIMS always a software?
 LIMS
• Be protected from unauthorized access
• Be safeguarded against tampering and loss
• Be operated in an environment that complies with provider or laboratory
specifications
• Be maintained in a manner that ensures the integrity of the data and
information
• Include recording system failures and the appropriate immediate and
corrective actions.
 LIMS
• When LIMS managed and maintained off-site or through an external provider,
the laboratory shall ensure that the provider or operator is suitable.
• What aspects to consider?

• The laboratory shall ensure that instructions, manuals and reference data
relevant to the laboratory information management system(s) are made
readily available to personnel.

• Calculations and data transfers shall be checked in an appropriate and

systematic manner.
Thank you …