W303 Management of data and its quality to ensure it is ...€¦ · Management of data and its quality to ensure its fit for purpose Presented by: Gugulethu Zwane 09 October 2013

Management of data and its quality to

ensure its fit for purpose

Presented by:

Gugulethu Zwane

09 October 2013

Test and measurement conference 2013

Misty Hills

OUTLINE

• Introduction

– Background on data management

• Chemistry laboratories

– Lab quality data and its management

– Sampling

– Analyses

• QA/QC data and its processes

• Conclusion

INTRODUCTIONBackground of data management

• Data management is the development, execution and

supervision of plans and programs that protect the value of

data.

• Administrative process by which the required data is

acquired, validated, stored, protected and by which its

accessibility, reliability and timeliness is ensured to

satisfy the needs of the data users.

• It helps to discover inconsistencies and other anomalies

in the data throughout its lifecycle (i.e. outlier, missing

data interpolation).

INTRODUCTIONBackground of data management

Why is data management important?

• To help optimise processes

• To enhance traceability

• Protect the needs of data stakeholders

• To protect the organizations integrity

• Build standard, repeatable processes

• Ensure transparency of processes

• Grants the laboratory a higher status

• Influences customer decision

INTRODUCTIONBackground of data management

INTRODUCTIONBackground of data management

• Deviations from internal processes expectations are

experienced from time to time during data production.

• The biggest challenge is controlling to a minimum with

the use of Quality control tools (i.e. Batch action,

production specs, result interfacing etc.)

• Data control measures influence the customer to “call

back” again for service

Data Management

through LIMS

Controlling

Validating

Protecting

Monitoring

Compliance to clause 5.9

INTRODUCTIONBackground of data management

Inorganic

Anions

R & D

Gravimetric

Metals

R & D

Gravimetric

Chromatography

Chemistry laboratories

Wet analysis

Data generation and its management

Organic

Hydrocarbons

screening &

quant..

CHEMISTRY LABORATORIESSummarised data

Inorganic Organic

Methods 21

90% accredit..

8

75% accredit..

Instrument 10

90% interfacing

9

89% interfacing

People 11 7

Sample Bottle Barcode Labels Scanner

Scanning - Date, Time, By Whom captured- Calculate time differences for process optimization- Proof of receipt- Eliminate errors (missing sample bottles)

CHEMSITRY LABORATORIESSampling (bottle prep)

•Scan the building from which departing

•Scan the Sampling Point on arrival

•Scan the Bottles at the Sampling Point

•Scan the Sampling Point on departure

•Scan the building to which returning

•Take the sample and perform field analysis

•In

the

field

at a

Sam

plin

g po

int

•Samplers at Lab Customer Services

CHEMISTRY LABORATORIESSample tracking

CHEMISTRY LABORATORIESSample tracking

•Upload Data from the handheld to LIMS

•Scan the full bottle After Sampling

•Store Bottles in the Cold Room

•Lab Personnel Collect the samples

•Scan Sample into the lab

•Laboratory

•Samplers at Lab Customer Services

CHEMISTRY LABORATORIESSample analyses

•Samples organisedin laboratory batches

•Laboratory instrumentation

•Result interfacing

•Batch actions/specifications

•Authorise

•Labware number remains unchanged

QA/QC PROCESSESDefinition

• Quality assurance

Planned and systematic production processes that provide

confidence in a product’s suitability for its intended

purpose.

• Quality Control

Inspection, tests or examination techniques used to ensure

that product conforms to specified requirements

QA/QC PROCESSESTools

• Batch actions_ to ensure only qualified data is exported

(SANS 241 , Rand water’s production spec & dilutions)

• Batch results as per maintenance log book.

• Check out of specification (on results exported)_ _ to

ensure only qualified data is exported (SANS 241 , Rand

water’s production spec & dilutions)

QA/QC PROCESSESControl charts

Proficiency Testing Scheme•To ensure the effectiveness of internal processes•Assures laboratory confidence•Demonstrates lab competence

Internal audits•Monitor compliance to procedures•Highlight areas of concern•Encourages continuous improvement•Promotes consistency

QA/QC PROCESSESPTS & Internal Audit

Conclusion

A good QC system is an effective tool of gathering and

monitoring data against all requirements. Neverthel ess,

deviations are inevitable during data production in the

laboratory environment, therefore the laboratory’s main

challenge is to trace, manage and reduce non-

conforming work .

•M.J Dlamini

•Analytical Services Chemistry team

•Analytical Services Customer services team

Acknowledgments

Thank you!!!