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Quality Assurance – Companywide, within Functional Areas
Table of Contents - Detailed Version
Objectives
Scope
Multilevel concept of quality assurance
Quality assurance instruments
Execution of quality assurance activities – companywide, within functional areas
Deliverables associated with quality assurance activities
Acting in a QC / QA advisory and training capacity
§ Objectives
× Securing protection against internal / external quality problems from objective evidence, with the information provided to serve following purposes:
› To assure the recipient that all is in compliance, that is, for example.
- The product / service provided is fit for its purpose and meets customer expectations; the process is behaving normally; the procedures are being followed.
› To provide the recipient with early warnings of trouble ahead and in doing so
- Place the recipient into a position to take preventive / corrective action to avert the troubles and / or derive improvement opportunities.
› To keep to the Leitmotif: “Fit-for-purpose” and, “Do it right the first time”.
§ Scope
× Companywide through quality audits, quality reviews / surveys / assessments and product audits.
× Within functional departments through additional forms of assurance.
› Covering all areas / activities including marketing, design, development, supplier relations, production, inspection and test, customer service / relations, documentation, professional performance.
§ Multilevel concept of quality assurance
× A formal quality assurance plan to be developed, which spells out, for all phases of product progression, from ‘cradle to grave’, how fitness-for-use can be achieved, provided quality controls are effective.
× A system of audits to verify, that the plans are actually being followed and quality controls being effective, to identify and correct non-conformances or to derive improvement opportunities.
× A system of reviews to verify the effectiveness of quality audits and audited plans, programs and concepts.
× A system to provide data on the quality achieved.
§ Quality assurance instruments
× Quality assurance manual.
› Covering the entire spectrum of activities through which management for quality can be achieved and commitment to customer satisfaction assured.
× Quality audits.
› Concerned almost exclusively with conformance of various sorts to discover discrepancies and alarm signals.
× Quality surveys / reviews / assessments.
› Requiring a broader view. Going further than structured audits, verifying the effectiveness of QA plans, QA programs, QA concepts, etc.
› Requiring the inclusion of matters not covered by agreed criteria.
› Discover in addition opportunities, and unexpected threats.
× Product audits
› Evaluation of outgoing product’s reliability to determine its fitness-for-use and conformance to specifications.
› For new products, to facilitate evaluation of the product development program, to detect what went wrong on new product launches.
› Purposes include:
- To provide a measurement against pre-established quality objectives.
- To record defect data used to define problems within the design or production process.
- To define areas of opportunity for corrective / improvement actions.
× Additional forms of assurance within functional areas.
› Involving the bulk of quality assurance activities and information, ranging from Marketing to Customer Service and including documentation, the qualification of professional staff and personnel development QA.
§ Execution of quality assurance activities – companywide / within functional areas
× Quality assurance manual.
› Description of the scope of the Quality Management System as an auditable entity.
› Development and writing as a standalone document, including all procedures etc.
› Specifying how the QMS is being observed, with emphasis on the business’ commitment to customer satisfaction through commitment to quality planning, monitoring, control and continuous improvement.
× Quality audits, including
› Audits of plans, systems, procedures, versus established reference standards for auditing against which to judge the adequacy of the plans.
- Directed at the entire family of elements of quality planning to judge their adequacy for meeting the quality mission of the company.
- Covering a wide range: All functions affecting quality. A single function (e.g. product development). A broad process (e.g. handing of complaints), or a single activity (e.g. calibration of equipment).
› Audits of execution versus plans, systems, procedures (quality system audits), to reveal activities, deficient in execution, such as:
- Use of obsolete specification documents during manufacturing.
- Use of process / test equipment with expired calibration dates.
- Inadequate feedback of inspection data to operating personnel.
- Chronic quality problems not identified and pursued.
- Inadequate quality requirements included in specifications to suppliers.
- Quality cost data not collected.
- Inadequate yield control program.
- Equipment downtimes due to inadequate maintainability, operating instructions and operator training.
× Quality surveys, reviews, assessments.
› Examples include:
- Gate Reviews: Compliance verification of the presence and agreed status of the required deliverables (work products) at gate and milestones, followed by milestone or gate review meetings.
- Examination of the product design specifications from the standpoint of product fitness-for-use, completeness and freedom from ambiguity.
- Examination of the manufacturing specifications and procedures for similar reasons.
- Review of manufacturing processes regarding problem detection and improvement of both, product quality / reliability and manufacturing productivity (yield, cycle times, equipment downtimes).
- Studies of inspection performance, inspector accuracy, test equipment accuracy, other aspects of inspection integrity.
- Reviews of customer quality complaints, and the actions taken in diagnosis and remedy.
- Third-party audit / survey. Evaluation of supplier quality, inspection of product or quality system.
- Comparative product portfolio assessment studies to support M&A decisions.
× Product auditing.
› Two forms of evaluations performed:
- Product reliability assurance tests. To detect significant problems.
- Periodic sample reliability tests, that is,
ê Quarterly reliability qualification tests to detect major changes in the manufacturing process as well as to assure that the design integrity is maintained throughout production.
ê Bi-monthly reliability sampling tests, similar to quarterly tests, but frequently used to make shipping decisions.
› Taking place at various stages after inspections have been completed on product samples ready to be shipped to customer, and through to performance in service.
› Correlation of outgoing quality / reliability is accomplished by comparing the product audit data to the field quality reporting system data and identifying the variances.
× Process quality assurance.
› Processes for project execution, e.g. project management, or
› Processes supportive for project execution e.g. configuration management or, supplier agreement management and reviewing.
× Quality assurance assignment.
› Upfront agreement between QA and all stakeholders for a certain project about QA activities being performed.
› Created in the specification and planning phase of a project.
› Documenting the extent of all QA activities and other services within a project scope.
› As stand-alone document or appendix to the Project Management Plan.
× Departmental assurance activities, examples include:
› Marketing, e.g. competitive evaluations, special surveys.
› Product development / NPI progression, e.g. design reviews, reliability analysis, reliability assurance, manufacturing, inspection and transportation analysis, pre-gate audits, project-process audits.
› Supplier relations, e.g. supplier surveys, materials evaluation / qualifications.
› Production, e.g. design review, process capability analysis, preproduction runs, FMEA for processes, review of manufacturing planning / process certification and control, configuration verification, audit of production quality including systems audit and product audit, statistical process controls.
› Inspection and test, e.g. inter-laboratory tests, measuring inspector accuracy.
› Metrology, e.g. measurement standards, gauge control, quality information equipment (QIE, incl. reliability, maintainability, accuracy and precision, procedures for formal evaluation of the QIE, operating instructions and training of personnel).
› Customer service, e.g. audit of packaging, transportation and storage.
› Professional staff /cross-functional teams, e.g. performance appraisals / coaching, mentoring, training.
§ Deliverables associated with quality assurance activities
× Typically in the form of documents, with configuration management to be applied to them, including:
› Audit reports,
- Concise, balanced in perspective, de-personalized, problem-oriented and constructive.
- Summary / verification of facts including supportive evidence and conclusions, with the impact of any deficiencies detected, analysed to become the basis of recommended corrective/ improvement actions.
› Review / survey reports.
- Summary of findings, detailed analysis of the severity / impact of the detected issues, key tasks requiring improvement / recommendations for issues resolution extended with process and / or organizational improvement / changes recommendations.
› QA assignment program.
- Describing specifically what will be audited, the level of auditing, how non-compliances are handled, the escalation criteria, whom audit reports are sent to, and an effort estimate.
- Addressing also additional QA activities, e.g., cooperation or interfacing with the QA department of a project’s customer or supplier.
› Executive summarized reports on quality - supplemented by independent audit reports as required -,
- Providing the bulk of quality assurance information derived from multiple sources of departmental / operational assurance activities, including.
- Executive reports about outgoing product quality and field performance (product reliability), based on product auditing results.
- Progress reports about results of quality improvement programs and / or verification of corrective / improvement actions.
§ Acting in a QC / QA advisory and training capacity. Matters include:
× Development of well-coordinated QC programs and concepts for all key functions involved in the entire cycle of New Product Progression, to prevent the occurrence of unsatisfactory quality, or to prevent problems from happening. Spanning all functions and QC aspects, ranging from:
› Design concept and feasibility (from design and development planning to verification and validation), reliability engineering, supplier / materials quality, manufacturing planning and production (design of the physical facilities and controls of process and product, including final product acceptance and process verification), through to shipment, maintenance and customer service.
× Development of appropriate, well coordinated QA plans for all the above phases along with a well coordinated system of appropriate audits:
› Extending over audit preparation, execution, evaluation, reporting up to follow-up and verification of CA.
› To provide assurance and alarms with respect to the continuing effectiveness of the Quality Controls, including
- Design assurance and reliability assurance programs.
- Inspection, measuring and test (quality information) equipment QA.
- QA of manufacturing programs (related to product performance, process variation, manufacturability assessment, process stability).
- QA of failure analysis system.
- Corrective and preventive action program.
- Quality cost programs.
- Quality information feedback system.
× Establishment of quality and reliability program requirements for suppliers, including supplier evaluation and qualification programs.
× Development of appropriate Systems of Reviews to review the effectiveness of QA activities and programs.
› Extending over review preparation, execution, evaluation, reporting through to follow-up, including
- Review of design for clarity of specs and producibility.
- Review of manufacturing planning.
- Review of in-process QA activities and final product acceptance.
- Review the effectiveness of corrective action programs.
- Review of customer service and of customer quality complaints.
- Review of the effectiveness of QS audit programs and quality information feedback.
× Establishment of a manufacturing data system adequate to report defects and yields.
› QA of the aforementioned data system.
× Development of a System of Data on the quality achieved, targeted at the establishment of a Quality Information System (QIS).
× Analyses of costs of poor quality (incl. chronic quality problems). Identification of major opportunities for improvement.
× Development, conduct, verification of training in QC and QA activities of individual employees and teams, including
› On-the-job training, spanning the entire product development cycle, including the training of production and inspection / test personnel.
› Training in defect prevention programs, statistical methodology, metrology, reliability analysis, analysis of causes of defects, establishment of cause-effect relationships, problem-solving methodology incl. 8D, new product reviews.
× Verification of required qualification / performance through performance appraisals on a regular basis.
› Management by objectives as preferred leadership style, to assure high motivation levels of team members along with mentoring and performance coaching to assure highest possible productivity and motivation levels.
× Involvement in creating change and hence in dealing with resistance to change through:
› Facilitating the dealing with cultural / social resistance to needed technical changes.
› Taking action to institute the changes.
› Instituting controls to assure the new level of performance.
× Preparation, writing, implementation of QC and QA manuals.
× Preparation, writing, implementation of manufacturing procedures and documents, of inspection procedures manual, and product and process, inspection / test manuals.
× Quality Assurance of the aforementioned manuals and documents.
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