QUALITY CONTROL

PROCEDURE FOR

QUALITY OBSERVATION IDENTIFYING, RECORDING, REPORTING AND MANAGING

Quality Observation

A Quality Observation is a departure from standard procedures or specifications resulting in nonconforming material and /or processes or where there have been unusual or unexplained events which have the potential to impact on product / service quality, system integrity or personal safety. For compliance to Good Practice and the sake of continuous improvement, these Quality Observations are captured in the inspection reports or ITRs etc and tracked in a. Types of Quality Observations Following are some examples of Quality Observation raised from different functional areas of Construction / production: 1. Construction Quality Observation - usually raised during the installation / fabrication work. 2. EHS Quality Observation Raised due to an environmental, health and safety hazards. 3. Quality Improvement Quality Observation - may be raised if a potential weakness has been identified and the implementation will require project approval. 4. Audit Quality Observation - raised to flag non-conformance identified during internal, external or supplier audits. 5. Customer Service Quality Observation - Raised to track implementation measures related to customer complaints. 6. Technical Quality Observation - can be raised for validation discrepancies. For example: changes in work procedure. 7. Material Complaint - raised to document any issues with regards to non-conforming, superseded or obsolete raw materials / components. Reporting Quality Observation A Quality Observation should be raised when there is a Quality deviation from methods or controls specified in contract documents, material control documents, standard operating procedure for products and confirmed out of specification results and from the occurrence of an event and observation suggesting the existence of a real or potential quality related problems. A Quality Observation should be reported if a trend is noticed that requires further investigation. All construction Quality inspections (planned or unplanned) covering all construction sites, equipments, operations, distribution, procedures, systems and record keeping must be reported and investigated for corrective and preventative action. Reporting of Quality Observation is required for any activity / documentation / materials rejected due to the error.

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QUALITY OBSERVATION IDENTIFYING, RECORDING, REPORTING AND MANAGING Different Levels of Quality Observation Risks For the ease of assessing risk any Quality Observation can be classified into one of the three levels A, B & C based on the magnitude and seriousness of a Quality Observation. Level A: Critical Quality Observation Quality Observation from Company Standards and /or current regulatory expectations that provide immediate and significant risk to product / service quality, safety or data integrity or a combination / repetition of major deficiencies that indicate a critical failure of systems. This shall be tracked as type A of observation and identified in the quality observation record as A. In addition to indicating in the quality observation record issuing an NCR against the violator is discretion of the Inspector / Observer. Level B: Serious Quality Observation Quality Observation are those would not cause any serious safety hazards or re-work or deviation from any standard of practices, but may effect a schedule impact or put on hold the next stage of activities etc. Level C: Standard Quality Observation Observations of a less serious or isolated nature that are not deemed Critical or Major, but require correction or suggestions given on how to improve systems or procedures that may be compliant but would benefit from improvement (e.g. in-appropriate data entry). If the corrective actions are not taken against type B and C observations within the stipulated time or the errors are repeated due to the lack of preventive actions or communication failure, QC department may issue an additional NCR against the responsible department. Type of Quality Observation Based on the nature of major quality issues on construction sites in the past, the type of Quality Observations are classified as 1. 2. 3. 4. Engineering failure Process failure Resource failure Improvement notes

Engineering Failure Misunderstanding the client's requirement to develop the design Using information which is incorrect or out of date Misunderstanding of the client's expectations of quality standards Lack of co-ordination of different discipline during engineering Vague or inappropriate specifications

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QUALITY OBSERVATION IDENTIFYING, RECORDING, REPORTING AND MANAGING Process failure during execution / construction due to Not followed drawings or specifications Poor supervision leading to bad workmanship Failure of complying Quality requirement during construction

Resources failure Product / material failure In-competent personnel, lack of training

Improvement Note Encourage adapting or implementing things which will contribute better output or appearance.

How to Manage Reported Quality Observation: For all scheduled inspections, if any Non conformities observed during inspection, Inspecting personnel should record the findings in the RFI (CH-F-QC-10 REQUEST FOR INSPECTION) raised by the performing department and send a copy to the site QAQC Engineer / QAQC department head for analyzing and further forwarding to the departmental corrective actions subsequently a copy to be issued to QC document controller for necessary tracking. For all surveillance inspections (unscheduled inspections), as soon as a Quality Observation is found, based on the nature of the non-conformities, if necessary issue stop work directive to the performer, write a short description of the fact and communicate to the responsible department officially subsequently notify the site QAQC Engineer / QAQC department head for analyzing and further forwarding to the departmental corrective actions. The correspondence shall be copied to QC document controller for necessary tracking. Site QAQC Engineer / QAQC department head shall evaluate the Quality Observation and assess the potential impact to the product quality, validation and regulatory requirement. All completed Quality Observation investigations are to be approved by QAQC Division Head or delegate. QAQC Division Head has to justify whether the Quality Observation is a Critical, Serious or Standard in nature. For a Quality Observation of either critical or serious nature QA delegate shall decide whether issuing an NCR against the non-conformity or not. If a critical or serious Quality Observation leads to an NCR, corrective and preventive actions should be determined and follow up tasks should be assigned to Discipline Engineers / Supervisors. Follow up tasks should be completed within stipulated time. If a Quality Observation with NCR cannot be completed given time, an interim report should be generated detailing the reason for the delay and the progress so far. For criticality Level B and C of Quality Observations Nonconformance reporting is not necessary. Immediate corrective actions have to be completed before the final Inspection / Testing / Commissioning / Hand-over. Final hand over is the responsibility of QAQC Department. After successful completion of the Follow up tasks, Quality Observation should be completed as closed and if necessary attach the related observation tracker with the corresponding Audit report / Work Inspection Reports / Safety investigation report as appropriate.

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QUALITY OBSERVATION IDENTIFYING, RECORDING, REPORTING AND MANAGING Note: - All quality observations shall be tracked in the log http://sp/Depts/QC/Lists/OBSERVATIONS Quality Observation Assessment:

QAQC delegate has to conduct a primary Investigation on the Quality Observation reported and evaluate the following information 1. Scope of the Quality Observation - work affected (both in-process and previously completed) 2. Trends relating to similar works, materials, equipment and testing processes, product complaints and /or client comments etc where appropriate. 3. A review of similar causes. 4. Potential quality impact. 5. Regulatory commitment impact. 6. Other works potentially affected. 7. Customer complaints. Identifying appropriate compliance measures Setting out the different means of corrective preventive measures listed in the table below. Proactively make contact with the violators to inform them of their obligations. Guidance material is to be made available for explain requirements. Departments to inform the violators (or all) about the regulation / contractual requirements to comply. And explain the negative impacts of non-compliance. Issue of Warning letters or show cause notices for not complying with requirements and issue penalty for it. The details of repeated offenders are to be publicized resulting in a loss of the violators dignity. Remove temporarily or permanently the offender from any further activity where a repeated violation has occurred. Refer to the top management for disciplinary action in the view of repeated intentional violations.

Advice Guidance material

Inductions

Warnings letters Publication of names of offenders Prohibition notices Legal actions

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QUALITY OBSERVATION IDENTIFYING, RECORDING, REPORTING AND MANAGING Management involvement After review of all major reported Quality Observations, QAQC divisional head shall communicate them to the performers divisional head, additionally; All NCRs and a monthly summary of Quality Observations shall be communicated to the Management at different levels for necessary measurement, analysis and improvement processes, to ensure that the processes and the actions are proposed being implemented and are effective.