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How to respond on non-conformities

ISTA Sampling Seminar June 16, 2014

Edinburgh, Scotland, UK

Dr. Rasha El-Khadem ISTA Accreditation and Technical

Department

Outline

• Definitions

• How to deal with non-conformities

• Challenges

• Findings from ISTA Audits:

• related to how to respond to non-conformities

• related to sampling

Definitions – ISO 9000

Non-conformity Non-fulfilment of a requirement

Requirement Need or expectation that is stated, generally implied or obligatory

Stated: stated for example in a document Generally implied: custom or common practice for the organisation, its customers and other interested parties

Requirements: ISTA Accreditation Standard ISTA Rules own documents


Requirement What about ISTA Handbooks? Are these requirements? Example: check of soil divider


Correction Action to eliminate a detected non-conformity (can be made in conjunction with a corrective action) Corrective action Action to eliminate the cause of a detected non-conformity or other undesirable situation Preventive action Action to eliminate the cause of a potential non-conformity or other undesirable situation

4 steps to follow

Non-conformities can occur at any time and there are different sources to identify them:

§ Internal audits

§ External audits

§ Customer complaints

§ Internal investigation

§ At any time during (routine) work

4 steps to follow

4 steps:

1) Record the non-conformity

2) Correct what can be corrected

3) Implement corrective actions § Investigate to find the root cause

§ Identify corrective actions

§ Implement corrective actions

4) Measure effectiveness of the corrective actions

Step 1

1) Record the non-conformity § Have a form available that is easy to fill in, have space

holders for all information that must be recorded (e.g. sample number, date, lot number, equipment, document, etc.)

§ During all steps this document will be used for recording

§ Even for ‘minor’ non-conformities the recording should be done to see the frequency

Step 2

2) Correct what can be corrected

§ This is a short term solution, only for this particular non-conformity

§ This only corrected the nonconformity, no investigation why this has happened or how to prevent this from recurrence

§ Examples: inform customer about delay for results

request an ISTA Certificate to be returned

Step 3

3) Define and implement corrective actions

§ Investigate to find the root causes of the non-conformity

§ Identify corrective actions

§ Implement corrective actions to remove the root cause. With this the non-conformity can not reoccur.

Step 3

3) Root Cause analysis Ishikawa / 7M / Fishbone / Cause & Effect Diagram

Step 3

Systematic approach, checking all possible areas

Step 3

3) The ‘5 Why’ root cause analysis

http://www.educational-business-articles.com/5-whys.html

Step 3

NC: The balance was not calibrated.

Root cause

Why?

Why?

Why? The number of “why” to be asked until the

laboratory gets to the root cause might vary

from non-conformity to non-conformity.

Why?

Why?

Step 4

4) Measure effectiveness of the corrective actions

§ Define the time when to measure

§ Define how to measure

§ Perform the measurement of effectiveness

§ Judge if the result is acceptable

§ If it is acceptable à close ‘the case’

§ If it is not acceptable à go back to you root cause analysis, maybe your root cause was the wrong one…

0.2

0.3

0.4

0.5

0.6

0.7

0.8

1 2 3 4 5 6 7 8 9 10 11 12 13 14

% e

rror

rat

e

time

Corrective Action

Preventive Action

Improvement

Problem Risk

Corrective versus Preventive Action: What is the difference?

CA versus PA

Corrective versus Preventive Action: What is the difference?

Corrective Action Preventive Action

Problem Existing non-conformity Potential non-conformity

Root cause Analyse and identify Possible cause to be identified

Action Define and implement

Evaluation Measure effectiveness Measure risk reduction

Follow-up measure

Define and implement

Reporting CA report PA report

The laboratory needs to think about: Ø Do we need to investigate for all non-conformities the

root cause?

Ø Is there always a root cause?

Ø How to deal with ‘human failures’?

Ø Do we really record all non-conformities or are we (or staff members) trying to hide some to please the statistics?

Challenges

Issues seen during ISTA audits Ø No procedure available for non-conforming work and

corrective actions.

Ø Corrective and preventive actions are not implemented.

Ø The laboratory did not follow up on corrective actions taken to ensure they are effective.

Ø Only non-conformities identified during internal audits are recorded.

Ø The laboratory did not follow up on non-substantial non-conformity identified during the previous ISTA audit.

Reality

ISTA audits - NC

ISTA audits – Sampling A - Automatic samplers

3%

D - Mixing and dividing

7%

E - Equipment (not suitable, not correctly

managed, labelling)29%

G - General1%

I - Instructions (SOPs and records)

26%

IC - ISTA Certificates

0%

L - Seed lot (something wrong with the seed lot

or labelling)1%

M - Methodology (How to use triers, primary

samples)13%

S - Sample (sample ID, sample size, sample

storage)7%

V - Verification of equipment

13%

Sampling NC by category (n=344)

29% Equipment, e.g. Triers not suitable Seed dividers not big enough Equipment not uniquely labelled Levelling of dividers Buckets to collect sample not suitable

Reality


3%


7%



G - General1%


26%


0%


or labelling)1%


samples)13%


storage)7%


13%


26% Instructions, e.g. SOP or form missing SOP incomplete SOP contains incorrect information Data not recorded

Reality


3%


7%



G - General1%


26%


0%


or labelling)1%


samples)13%


storage)7%


13%


13% Methodology, e.g. Sampling done incorrectly Incorrect use of triers Issues with size of primary samples

Reality


3%


7%



G - General1%


26%


0%


or labelling)1%


samples)13%


storage)7%


13%


13% Verification, e.g. Dividers not verified

Reality


3%


7%



G - General1%


26%


0%


or labelling)1%


samples)13%


storage)7%


13%


7% Mixing and dividing, e.g. No mixing done Incorrect mixing Incorrect use of spoon method

Reality

Questions?

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