Effective Deviation MetricsMatthew Schoerie

Senior Consultant

A word of caution for any metrics

What is a deviation?And is it just another name for incident management?

PIC/S Definition

PIC/S Expectations

Significant deviations are fully investigated, prior to batch release

QC – any deviations are fully recorded and investigated

Assessment of deviations from specified procedures

Incorporate risk assessment

Signed authorisation for deviation from manufacturing formula, processing instructions and packaging instructions

PIC/S Expectations

• Written policies, procedures, and the associated records of actions taken or conclusions reached of any deviations or non-conformances

• Planned deviations, should be avoided as far as possible; should be approved in writing

• Any deviation from expected yield should be recorded and investigated

• Reviewed in PQR

What is the purpose of Deviation management?

“From an Regulatory or cGMP perspective, the purpose of conducting a deviation investigation is not to “release the batch.”

The true purpose of a deviation investigation is to:

determine the root cause for the “deviation”,

implement appropriate and meaningful corrective actions,

evaluate the implicated system (e.g., the training program) once a pattern of repeating deviations is noted.

Cornerstone of continuous improvement program

Deviation management is a tool to build in Quality to your products

“What is tested is not sold,

What is sold is not tested”

So, Quality is not testing of

product. It should to be built in

each stage of process/operation.

Maximising the probability

that the finished product

meets the quality and design

specifications.

Questions?

DefinitionsAnd how they may impact your reports

Types of Deviations

Planned

Pre-approved period of time / batches

Should not be used for any unintentional deviations

May be managed through change control

Unplanned

Incident defined as non-compliance to procedure or

system at any stage of manufacturing, packaging,

testing or storage

Planned deviations

Planned deviations can be handled through approved change control procedures.

All changes / deviations should be evaluated for product impact, significance, and the need for requalification or revalidation.

Generally, manufacturers should work hard to

not use planned deviations, as minimal

planned deviations demonstrate process

control, stability, and repeatability

Unplanned Deviations / Incidents

Incorrect charging of raw materials

Temperature, pressure, humidity parameters outside defined limits and require non-standard remediation

Operating instructions not correctly followed

Breakdown of process equipment or failure of utilities

Equipment out of calibration

Production records not adequately completed

Temporary alteration to defined production instructions

Alternative production equipment used at short notice

Deviation Management –

A Risk based approach

Two Questions to answer

Does the event contradict or omit an approved written procedure or specification?

Can the event affect a product attribute, manufacturing operational parameter or the product’s quality?

Deviation Management Process

Draft - Deviation Handling and Quality Risk Management

World Health Organisation – July, 2013

Draft - Deviation Handling and Quality Risk Management

World Health Organisation – July, 2013

Deviation Management Process

Categorisationof Deviations by risk

Minor

Does not affect any quality attribute, critical process

parameter, or an equipment or instrument critical for

process or control.

Major / Critical

May impact on product quality, will QA approved

corrections and require an adequate investigation and

follow up actions.

Note: A pre-existent QRM will always help answering

these questions and categorizing the events.

MeasuringEffectiveness of your Quality Systems

Categorisation Type of fault

By Piece of equipment

Recurrence By Type

Effectiveness of CA/PA

Deviation Type Never been there before

Something changed

Trending your data vs. Trends in your data

Measuring your management systems

Effective Management Systems

Timely & contemporaneous reporting

Clear root cause identified

Timely close out

Corrections implemented

Passed to independent CA/PA system

Batches released under deviations

% deviations not closed or cancelled

Tagging of deviations

Automated Quality Reviews

New opportunities, bring new questions

Electronic systems