Activities Which Should Be Done By Companies (Contractor – Subcontractor) in Assessments
The systematic and objective examination and assessment on the basis of documents and statements of whether the activities o
Tarih: Issue 9 - January 2008
In assessments, evidences should be examined according to the provisions identified in order to provide objective evidences. These identified provisions are:
1. Contracts: This kind of requirements, which were notified to organization by the customer, has priority and these provisions can be considered during assessment.
2. Quality System Provisions: Since the provisions identified in these documents were the requirements identified by being predicated on the standards applied by the administration of the organization, they provide support for the examination.
3. Standards of Quality Management System: If an institution wants conformity to such a standard, the system of the institution should meet the requirements for this standard.
4. Legal Provisions: Since application of legal provisions is obligatory, they must be considered in the assessment.
5. Rules of Certifying Institution.
Assessment of Quality Management System is the whole of activities including
Conforming whether the institution is working according to documented procedures,
Determining documented procedures and efficiency of the activities done according to them,
Identifying week points, improprieties, and field open to rehabilitation in the quality management system,
Interior examination activities in order to provide contribution of personnel in rehabilitation activities,
Identification and reporting of existing conformable and improper situations by educated personnel’s examination of a part or a process of an institution with certain authorization and in the framework of a plan according to related procedures/directives.
The point to consider in the Assessment; It is impossible to examine all documents during the assessment. Because of this, only chosen subjects can be examined. Assessment officers must declare this sampling method before the assessment.
Minimum Activities required in Contractor – Subcontractor Assessments are listed below (but not limited to them):
Quality Management;
• organizational hierarchy should be provided in order to execute Company Quality Management System with policy, mission, vision and strategic planning in an organized structure,
• Yearly objectives should be determined, the realization status of objectives should be measured,
• Objectives about Quality Management should be created, realization status of them should be followed,
• The activities and functional responsibilities of Quality Management with Quality Assurance and Quality Control parts and with other parts should be defined,
• The activities and functional responsibilities of parts of Company should be defined in order to provide cooperation, coordination and information flow in the quality related studies and executions,
• Executions about the defined responsibilities should be monitored,
• Procurement Authority / User opinions/demands/complaints should be taken as feedback, assessed, measurement activities should be set off,
• A separate quality budget from the company budget should be formed for the quality organization yearly expenses,
• Quality costs should be monitored,
• Activities about coordination/cooperation should be done by providing continuous coordination with the customer,
• Quality Plan should be associated with process plan and other plans.
Planning:
• Project plan should be prepared,
• It should be explained how work planning, management and monitoring in the company In the project planning process,
• Risks should be considered in planning, risk decreasing activities should be determined and project risk plan should be formed,
• In planning, requirements should be considered and monitored, and project requirement plan should be formed,
Documentation
• It should be defined how control of all documentation and registrations about the contract requirements will be done,
• Documents should be checked for suitability and adequacy before published,
• Criteria, determined for document control and approval activity, should be defined and executed,
• Methods should be determined for providing approval in the situations require customer approval,
• Revision changes should be defined, executed and monitored,
• Appropriate methods should be formed in order to prevent usage of invalid documents,
• Methods should be formed in order to access all records and documents,
• Time for keeping records should be determined, methods for the procedure about expired documents should be defined,
Contract
• Activities carried out during the revision process of the contract should be defined, how coordination and cooperation among parts is provided should be explained,
• Contract method should be determined,
• It should be explained how relations with customer is provided in related processes and with what kind of a cooperation,
Purchasing
• A document, which defines Purchasing process about purchasing system, subsystem and all other materials to provide input in production, should be prepared,
• Activities about formation of sub contractor system, product quality in the scope of subcontractor control, revision of performance of subcontractor according to project plan and contract requirements, should be done,
• First Article Inspection (FAI) should be done before purchasing for a material which will be bought for the company and will be used for the first time,
Design - Development;
• Design documentation that shows the duties of related parts of the company about the design and activities to be executed in each phase, should be prepared,
• How design inputs provide product validities written in the contract should be explained,
• In the phases placed in the design plan, periodic revisions should be done, results should be issued, decisions should be formed about the project according to these results,
• How activities based on coordination and cooperation between Supplier – user and company are carried out and how occupied data are considered in design project should be explained,
• Demands about product should be defined,
• Design inputs and outputs should be compared,
• Activities about formation, execution and monitoring design changes should be defined and realized,
• Activities, carried out during design confirmation/approval process, should be defined,
• In related documents, activities on monitoring design changes, registering and controlling them, forming improver and preventing activities should be explained,
Production
• Duties and responsibilities of production unit should be defined,
• Required “Special Processes” should be determined and training requirements should be defined for the personnel, who will carry out them,
• “Critic”, “Replaceable/Interchangeable” equipment to be used in production should be determined and monitoring/controlling methods for them should be defined,
• Requirements of production documents should be defined,
• Production material with “shelf life” should be determined and monitoring/control methods should be defined for them,
• Production flow control management/methods should be defined,
• Measurement/test equipments to be used in production should be determined and calibration requirements about them should be defined,
• In order to prevent improprieties from the measurement and test devices in the production process, the execution of statistical techniques and calibration services should be provided,
• Criteria, which will be used in the determination of calibration intervals, should be determined, according to what principles the calibration is done should be defined,
• Accuracy limits of measurement devices, which will be used for tests, should be determined,
• The procedures, which will be used for the products checked with disqualified device, should be determined,
Test and Assessment
• The ability to be tested of all requirements in the project should be determined,
• Inspection, analyze, demonstrate or test should be explained for all requirements,
• Methods for solving improprieties should be defined in test planning,
• (method /procedure) refusal/acceptance criteria should be defined in test document,
• Methods and applications should be defined for removal of improprieties met during acceptance processes and they should be used,
• The keeping procedures for the records, which show the product checked in accordance with accepted criteria, should be defined and how sharing with the customer will be should be defined,
• How calibration activities are done should be defined,
Configuration Management
• Management system about determination, monitoring and execution of configuration activities should be formed,
• Configuration Supervision activities should be formed and carried out,
• Board of Configuration Control should be defined,
• It should be defined how the classification of configurational changes will be done,
• It should be defined how interface/communication with the customer will be provided in the approval process about configuration changes,
Production Definition and Ability to be Monitored
• It should be defined and carried out how ability to be monitored of each production phases is provided about production for the past and future,
• It should be defined how product is monitored throughout “Life Period”,
• A method should be defined about applying modifications, decided to be applied on the product as a result of R&D activities, on the products still being used if product design belongs to the company,
• It should be defined how user opinions/demands/complaints are evaluated,
• It should be defined whether user opinions/demands/complaints are used in R&D and design activities,
• Activities about forming or developing a repair/maintenance (Logistic) concept by considering configurational features of system, subsystem and parts of the product, should be defined,
Measuring and Analyze
• It should be defined which methods are used in following and measuring quality management system processes,
• The required information in order to assess and develop suitability and effectiveness of quality system should be defined,
• Analyses should be done with the data about customer satisfaction, suitability to customer requirements, characteristics of process and products,
• Required data about customer, supplier, product and process should be determined,
• Written documents, which will guide execution of statistical techniques, should be prepared,
• The personnel, who will use statistical techniques, should have perfection in these techniques,
• Required processes and tools for data obtaining and analyze should be defined,
• Revision activities and data confirmation control activities should be done,
• A gathering/obtaining method should be defined for each obtained metrics,
• Determination of errors, their analyze, determination of frequent error data should be done,
• A mechanism should be formed in order to determine how much time, money, resource and effort is spent in error determination, united revisions, tests and error prevention activities,
• Product should be measured whether it meet the requirements,
• Variability/variance values of process/product should be determined,
• Control process outputs and situation reports should include required activities, results of risk management, deviations in plans, improprieties, updates in plans, and if required updates in contracts,
• There should be documents in which results of measurement are evaluated periodically,
• Project data should be reviewed periodically,
Adjusting/Preventative Activities
• Activities about adjusting and Preventative activities should be defined, it should be explained how the executions will be done,
• It should be stated where data about Adjusting/Preventative activities are obtained,
Improprieties
• The preventing of mistakenly usage and shipping of the product that doesn’t meet requirements should be defined,
• Effective contact methods with customer should be provided about improper product,
• Activities should be defined and carried out in order to solve the impropriety problems and prevent their repetition,
• Improprieties should be reviewed,
• The causes of improprieties should be searched,
• Adjusting/Preventative activity should be started,
• The results of Adjusting/Preventative activity should be recorded and its effectiveness should be evaluated,
• If improper product is met after delivery or during the usage, appropriate activities should be carried out against existing/possible effects of impropriety,
• Some definitions should be defined about the possible improprieties occurred during storage, packing and shipping,
Rehabilitation
• Rehabilitation inputs/methods should be identified for process and product,
• It should be explained how rehabilitation activities are done, executions should be done.
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Result:
The benefits of assessment:
It helps management, It provides real data with objective assessment principle.
It helps development of quality system.
It is done in order to determine appropriate and effective elements of quality system.
It helps institution to reach its objectives.
It provides assurance about the suitable preparations to reach quality.
It provides assurance that products are appropriate for usage and are safe for user.
It provides assurance that laws and regulations are applied.
It helps determination of capabilities for improvement.
It corrects prejudiced opinions about status, procedures and training capabilities of management systems.
It provides assurance about the sufficiency and following of documents.
It improves communication and provides direct report for senior administration.
It provides confirmation of applicability of contract provisions.
It provides confirmation of effectiveness of quality management.
It becomes a useful training for the personnel.
It helps the improvement of personnel’s responsibilities about their activities.
Contractor – Subcontractor companies will provide customer satisfaction by performing customer contract provisions in addition to have an effective management system when they perform the provisions given above. While this is bringing new projects along with itself, it will provide being a world wide company and sustainability. I hope all defense industry companies will realize successful projects, which opens horizons, in 2008.