QMS Team: MR and all HODs (Internal Auditors) MR March 10. Quality policy Define quality policy The Steering committee Objectives and targets

Transcription

1 QMS Roles, Responsibility and Authority Process Clause Activities Records Required Responsibility Authority Deadline Clause 4: Process Development 4.1 Develop processes and sequence, operation controls of processes, develop control of outsourced process, Set measurable targets for the processes and analyze processes. Quality policy Define quality policy The Steering committee Objectives and targets Establish the QMS objectives, target and programmes. Establish and implement documented procedure required by the standard and the organization Quality Manual Maintain quality manual Define Scope and justification of exclusions and activities in 4.1. Documented procedure or refer to them Description of interaction of processes Document and record control Control all document Establish and implement document control procedure to fulfill clauses 4.2.3a-g Control of record Control Ensure are legible, readily identifiable and retrievable Establish and implement documented procedure to define controls for identifying, storing, protecting, retrieving, retaining and disposing. Document control Records MR March 10 CEO MR MR March 20 IT, and all HODs IT April 24 IT, and all HODs IT April 24 Clause 5: Management responsibilities 5.1 Quality Policy, Objectives, conduct management review and provide resources for QMS The Steering committee CEO

2 Customer focus 5.2 Determine customer requirement and meet it. Activities in and Quality policy 5.3 Ensure quality policy include commitment to comply with QMS Develop procedure for setting and reviewing objectives. Communicate quality policy throughout the organization. Review quality policy to ensure continuing suitability. Quality objectives Set quality objectives and targets at all Roles responsibilities and authority levels and functions` Define roles responsibilities and authorities and communicate them within the organization Management Representative Appoint MR with addition job description as stated in the clause Internal communication Establish appropriate communication process and implement the processes Management Review Set management review (MR) time and interval, conduct Management Review at agreed interval in accordance with the review input and output in clauses and Management Review meeting minute The Steering committee The Steering committee CEO CEO MR March Done MR May 8 CEO June 10 Clause 6: Provision of resources 6.1 Provide resources to Implement and continuously improve QMS and satisfy customers Competency, training and awareness Conduct job analysis, Identify training needs, provide and develop trainings, evaluate training, Keep training record Records of education, skills, training and experience CEO/ Finance Dept On-going HR dept HRM March

3 Create awareness of the job relevance and importance to QMS Infrastructure 6.3 Provide and maintain building, workspace, utilities, process equipments (hardware of software) and other supporting services (transport, communication of information). Work environment 6.4 Manage and maintain the work environment such as physical, environmental and other factors like noise, temperature, lighting, humidity or weather Incident Record All HODs Admin, Finance, I.T and maintenance Departments HSE, Admin and Finance Maintenance April 10 HSE March Clause 7: Planning of service realization Determination of service requirement Review of service requirement Customer communication 7.1 Develop process and documents for service realization, Determine product requirement, Determine verification, validation, measurement and testing activities for service acceptance Determine customer requirement, Regulatory requirement and other requirements Review service requirement prior to commitment to render services, define service requirement, resolve changes/ changing service requirement Develop procedure for customer communication and communicate with respect to services information, customers feedback and complaints. Records demonstrating that the products (and realization processes) meet all customer and legal requirements. Records of the review of product requirements prior to realization Dept Dept Dept Dept 7.3 Design and Development This clause is excluded because the N/A

4 organization does not design or develop services. Purchasing Ensure service conform to requirements, Evaluate and select suppliers according to meet organizational requirement, Develop criteria/procedure for selection, evaluation and re-evaluation of suppliers Purchasing information Develop purchasing information to include: -Requirement for approval of products, procedures, processes and equipment -Requirement for qualification of personnel -Ensure adequate purchase requirement Verification of purchased products Control of service provision Validation of processes for service provision before communication with customers Develop procedure to Inspect, verify or ensure purchased product meet purchase requirement Control the planning and provisions of service: Provide information about your services Provide work instructions Use suitable equipment Provide and use monitoring and measuring equipment Monitor and measure service delivery Implement delivery and post delivery activities Where a process cannot be monitored, you : Validate the processes Defined criteria for process review and approval Approve equipment and qualification of Supplier evaluation and selection Record of verification or purchased product Validation of process for production and service provision Department Department Department Dept Dept

5 Identification and traceability personnel develop validation methods and procedures Develop suitable means or procedure to identify product throughout the service realization. Identify product status throughout service realization Control the unique identification of the product. Customer property Identify and protect customer property in your custody Report loss of customer property to the customer. Generate corrective action Keep record Preservation of product Preserve product during internal processing ( identifying, handling, packaging, storage and protection) and Control of monitoring and measuring equipment delivery 7.6 Determine the type of monitoring and measurement to be undertaken and equipment to be used. Develop monitoring and measure processes and procedures Calibrate/ verify or both measuring equipment at regular interval or prior to use. Keep record of basis of calibration Label measurement equipment to identify its calibration status. Protect measuring equipment from unnecessary adjustments, damages and deterioration during handling, maintenance and storage Product Identification and traceability Records of loss or damage to customer property Record of basis of calibration and verification Record of result of calibration Dept Security and operations Dept. Dept Maintenance Department Operation and PFSO Maintenance manager

6 Measurement analysis and Improvement Keep record of validation of previous measuring result after discovering inaccurate measurement result 8.1 Develop processes and procedures for monitoring, Measuring analysis and improving QNS Determine applicable methods- including statistical techniques- and extent of use Customer satisfaction Monitor regularly customer perception as to meeting customer requirements Determine the methods of obtaining and using information Dept. April 24 Internal audit Conduct internal audit at planned interval Determine audit criteria, scope, frequency and methods Develop procedure for defining responsibilities and requirement for planning auditing, establishing record and reporting results Keep record of audit and their result HOD of the audited department shall ensure the implementation of corrective actions without delays. Follow up on corrective action. Monitoring and measurement of processes Monitoring and measurement of services Develop procedure and techniques for monitoring and measuring QMS processes Implement corrective actions for process failures Monitor and measure services provision at appropriate stage in the service provision process to ensure customer requirements have been met Record shall indicate the person authorizing delivery to customer. Internal audit Records of product conformity to requirements and release to customer Lead auditor and All HODs(Internal department Dept. Lead Auditor April- 5 May manager April 10 April 10

7 Withhold service delivery until clause 7.1 is fulfilled. Control of nonconforming product 8.3 Identify and control no-conforming service Develop and implement procedure for defining controls and assigning responsibilities for dealing with nonconforming products Deal with non conforming product Re-verify corrected non-conformity to demonstrate conformance to customer requirement Keep record of non-conforming product and the corrective actions taken. Analysis of data 8.4 Determine, collect and analyses appropriate data to evaluate the effectiveness of the QMS and potential improvements. Information to be generated from analysis: Customer satisfaction Conformity to product requirement Characteristics and trends of processes and products and preventive actions Suppliers feedback Records of Nonconforming products department Dept. manager April 24 April 24 Continual improvement Continually improve the effectiveness of QMS through quality policy and objectives, audit results, analysis of data, corrective and preventive actions and management reviews Corrective action Take actions to eliminate cause of nonconformities Develop procedure to: review nonconformities (including customer complaints) Corrective action Lead auditor and All HODs(Internal Lead auditor and All HODs(Internal MR Lead Auditor May 6-June 6 May 6-June 6

8 Determine causes of and actions to eliminate causes of nonconformities Take corrective actions Keep record Review the effectiveness of corrective actions taken Preventive action Take actions to eliminate potential cause of nonconformities Develop procedure to: Determine potential nonconformities and their causes Evaluate the need for action to prevent nonconformities Determine and implement actions needed Keep of action taken Review the effectiveness of preventive actions taken Preventive action Lead Auditor and All HODs(Internal MR May 6-June 6