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Industrial Technology Institute Identifying Non Conforming Work & Corrective & Preventive Actions VER 6 Kaushalya Piuminie Wijekuruppu Quality Assurance Department 24th August 2011 S.F. Laurentius Auditorium

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Page 1: CA & PA

Industrial Technology Institute

Identifying Non Conforming Work &

Corrective & Preventive Actions

VER 6

Kaushalya Piuminie WijekuruppuQuality Assurance Department

24th August 2011 S.F. Laurentius Auditorium

Page 2: CA & PA

Industrial Technology Institute 2

What is Non-conformity (NC)?

Cont…

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Industrial Technology Institute 3

There are many types of requirements. Some of these include,

Quality requirements (ISO 17025),

Customer requirements, Management requirements, Product requirements &Legal requirements

Whenever an organization “Fails to meet” one of these requirements, a NC occurs

All NCs are costly Cont….

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Industrial Technology Institute 4

Identification of Non-conformities Every Laboratory employee is responsible for being aware of any Existing or Potential NCs of the activities of the Quality System, in their or any functional section of the laboratory

Therefore any employee of lab may

identify the NCs & propose initiation of the corrective actions

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Write the NC giving meaning to the following “KEY WORDS” without any ambiguity

Industrial Technology Institute 5

Expression of NCs?

What – What was found?

When – When is it a NC?Where – Where was it

found?

Why – Why is it a NC?

How – How is it a NC?Who – Who was responsible?

Cont…

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Clearly express the NC

Industrial Technology Institute 6

Cont…

It must be, Non-blaming statements of fact

Based on recorded objective evidence

Directly related to the specific documented requirement

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Major: A failure of QMS or complete omission of a QMS requirement (ISO 17025 requirements)

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Major & Minor NCs Minor: Failure to comply

with a procedure or requirements in QMS which adheres the laboratory

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Corrective Actions (CAs) or Preventive Actions (PAs) should be proposed for identified NCs

Proposed CAs/PAs are implemented in the area of concerned

Only the Head/Manager of Laboratory or the Quality Manager can authorize and request for their implementation

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Control of Non Conforming Services

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The assignee, which usually is a person from the affected area, is responsible for the implementation of corrective or preventive action, and recording them in relevant formats

The Quality Manager/Head/Manager of laboratory is responsible for verifying that the Corrective or Preventive action has effectively eliminated the cause of the nonconformity

Except raising NCs by the sectional staff NCs are raised at the Internal Audits

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Corrective Actions & Preventive Actions

Corrective and Preventive Actions are key elements in a Quality Management System

(QMS) that is focused on Continual Improvement and Customer Satisfaction

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What are Corrective & Preventive Actions?

Corrective ActionsAction taken to eliminate the cause of anEXISTING non-conformity, defect or otherundesirable situation in order to prevent recurrence

Preventive ActionsAction taken to eliminate the cause of a POTENTIAL Non-conformity, defect or other undesirable situation in order to prevent occurrence

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Corrections & Corrective Actions“Correction” refers to the immediate actions taken for

a detected NC such as repair, rework or adjustment and relates to the disposition of an existing NC

“Corrective Action” relates to the elimination of the root causes of NC

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Industrial Technology Institute 13

Examples for Corrective ActionsNon conformity No.1 Staff Files contain documents which are not required by QMS. Certain staff files were incomplete. No training evaluation report for participated trainings (Staff File of Mr. A) Although training evaluation form & training certificates were attached, relevant details are not filled in staff details format (Staff File of Mr. B)

Corrective action/s Staff files to be updated properly Awareness to be given to the staff about proper record keeping practices

Cont……

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Examples for Corrective ActionsNon conformity No.2 Obsolete format (Form: 8/MM/01) is used to record the staff meeting minutes although the new format is QM/FORM/05-03/V 1.1

Corrective action/s To use the current version for staff meeting minutes. Awareness to be given to the staff members about the current

QMS formats whenever the formats are updated.

Cont…..

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Examples for Corrective ActionsNon conformity No.3 Measuring probe/ glass electrode of the pH meter is not working properly.

Corrective action/sOperators are to be made aware to keep pH glass electrode in 0.1 mol/L HCl after using and are to be trained on safe handling of the pH meter

Cont…..

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Examples for Corrective Actions

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Non conformity No.4 Calibration details/status are not displayed on the equipment

Corrective action/s Calibration status/details to be displayed on the relevant equipment without delaying after the

calibration

Cont…..

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Examples for Corrective ActionsNon conformity No.5Temperature recording of media storing refrigerators is not practiced regularly

Corrective action/s1.To assign an authorized person to maintain and record the temperature of refrigerators regularly and make them aware on the significance/importance of their tasks2. To assign a supervisor to check the proper functioning of the procedure Cont…

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Industrial Technology Institute 18

Examples for Corrective ActionsNon conformity No.6An incorrect test report has been issued to a customer

Corrective action/s1.Assign a person to check each and every test reports before submitting to the customers 2. The checking officers & authorized signatories to make aware on the importance of checking all data in a Test report before issuing to the customer Cont…..

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Examples for Corrective ActionsNon conformity No.7Raw data sheet for the determination of Total Phosphorous in water not checked signed by the supervisor

Corrective action/s1. The checking officers & authorized signatories to make aware on the importance of checking all raw data sheets prior to enter in test report 2. To check and sign the all raw data sheets by authorized supervisory personnel Cont…..

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Examples for Corrective ActionsNon conformity No.8Although Mrs. A is not authorized for water testing she has analyzed a water sample and signed a test report as the

analyst

Corrective action/s1. To authorize her immediately and keep relevant records in

the staff files

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Industrial Technology Institute 21

How to Initiate Preventative ActionsPreventive actions can be initiated through, Reviews (contracts, purchasing, processes, designs) Employee Training Programs Preventive Maintenance & Calibrations Management Review of Quality Management System Statistical Process Control (SPC) Analysis Monitoring of supplier performance Capability Studies, Cause & Effect Analysis Disaster Recovery Planning Trend Analysis Benchmarking

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CAs & PAs Through CAPA Procedure Identification: Clearly define the problem Evaluation: Appraise the magnitude & impact Investigation: Make a plan to research the problem Analysis: Perform a thorough assessment Action Plan: Create a list of required tasks Implementation: Execute the action plan Follow up: Verify and assess the effectiveness

Make sure actions taken are not simply a Band-Aid

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Sources of Causes for NCsDeficiencies in,

Communication Documentation Personnel training & motivation/competency Materials Tools & equipments The operating environment Supervision

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How to Identify the NCs? Identification of NCs can be done through activities

such as, Checking documents related to QMS Analysis of customer feedback and complaints Analysis of data with respect to customer

satisfaction Review or analysis of services delivery, process

performance & quality of deliverables Analysis of performance of suppliers or service

providers Delay status of services Review of outstanding