quality development audit - sabs quality development audit guide element/generic audit question...

Quality Development AuditGuide

SABS Quality Development Audit FA.indd 1 2012/02/05 10:44 PM

SABS QUALITY DEVELOPMENT AUDIT GUIDE

Element/Generic Audit Question Comments/requirements

1. Element: Product Design Planning

1.1 ARE THE CUSTOMER REQUIREMENTS AVAILABLE?

1.2 IS A PRODUCT DESIGN PLAN AVAILABLE AND ARE THE TARGETS MAINTAINED?

1.3 ARE THE RESOURCES FOR THE REALISATION OF THE PRODUCT DEVELOPMENT PLANNED?

All customer requirements for the product to be developed must be known and included in the development.

For example, the following points should be considered:

• Drawings, standards, specifications, performance specification

• Logistic concepts

• Technical specifications, test specifications

• Quality agreements, target agreements

• Important product/process characteristics

• Purchase order documents with parts lists and delivery dates

• Legislation/directives

• Waste management plans, environmental aspects

The product development plan is an integral part of the project plan and stands in correlation with the process development plan. All activities, including those for suppliers, are to be established until start of series. The targets must be derived from the requirements and maintained at the project establishment phases.

The following points should be considered:

• Customer requirements

• Costs

• Milestones: Planning/Purchasing release, modification stoppages

• Pilot production, start of mass production

• Resources allocation for manning

• Setting and monitoring the target

• Regular information to the company management

Are the required resources considered in the quotation phase? After the award of contract, the details must be stated precisely. When requirements are altered, an update of the resources study should be carried out, if necessary. The required means must be planned and made available.



• Qualified personnel

• Lost time through absenteeism or industrial actions

• Throughput/processing times

• Buildings, premises

• Tools/equipment

• Test/inspection/laboratory equipment

Are all requirements known and up to date? For example, Letter of Authority (LOA)

• Product specifications

• Significant characteristics

• Packaging/logistic requirements

• Project timing and milestones

Are legal/environmental requirements known and up to date?

Are the documents controlled, updated and distributed to the relevant functions in case of modifications?

Has a product development plan been compiled and is it linked to the overall project plan?

Does it include milestones, timing schedules and deliverables?

Is the progress tracked and reviewed?

Are design reviews planned and undertaken?

Are design verification test contents and timing planned?

Are the resources needed for product development identified and planned?

• Personnel

• Design facilities

• Prototype/manufacturing facilities

• Inspection and test facilities


Element/Generic Audit Question Comments requirements

1.4 HAVE THE PRODUCT REQUIREMENTS BEEN DETERMINED AND CONSIDERED?

1.5 HAS THE CONTRACT REVIEW BEEN DETERMINED BASED ON THE AVAILABLE REQUIREMENTS?

1.6 ARE THE NECESSARY PERSONNEL AND TECHNICAL CONDITIONS FOR THE PROJECT PROCESS PLANNED/AVAILABLE?

The requirements of the product are to be determined through multi-disciplinary co-operation/benchmarking. Previous experiences and future expectations must be included in the consideration. The product requirements must meet the market requirements and customer expectations, the product must be competitive.



• Company objectives

• Robust design/safe process

• Regular customer/supplier meetings

• Important characteristics, legislation requirements such as safety markings

• Functional measurements

• Fitting measurements

• Material

The known requirements must be checked for feasibility through multi-disciplinary co-operation. The customer requirements have special significance here.

Requirements for the following aspects should be considered:

• Design/engineering

• Quality - process equipment, resources

• Special characteristics such as safety markings

• Company objectives

• Directives, standards, legislation

• Environmental aspects

• Delivery dates/time frames

• Cost frame

The required personnel qualifications and means are to be determined prior to the start of the project and included in the project plan.


• Project management, project planning team/responsibilities


• Communication means (electronic data transfer)

• Information flow from and to the customer during planning (regular meetings, conferences)

• Tools/equipment including plant personnel protective equipment (PPE)


Are reliability targets defined? Aspects such as shelf life and durability would be reflected on the packaging.

Are historical problems/concerns and corrective actions taken into consideration?

Do the suppliers’ drawings/specifications match customer requirements?

Has a feasibility study been completed?

Is the feasibility committed to customer?

In case of product modifications, is the feasibility re-evaluated?

Has a cross-functional project team been appointed and are the members sufficiently qualified?

Have the contacts been communicated to the customer?

Is the progress (project tracking, project plan updates and related detail reports) regularly communicated to the customer?

QUALITY DEVELOPMENT AUDIT GUIDE


Comments/requirements

2. Element: Performing Product Design

2.1 HAVE THE DESIGN RISKS BEEN RAISED AND ARE IMPROVEMENT MEASURES ESTABLISHED?

2.2 IS THE DESIGN RISK TOOL UPDATED DURING THE PROJECT PROCESS AND ARE THE ESTABLISHED MEASURES REALISED?

2.3 IS A QUALITY PLAN PREPARED?

The product risks must be pointed out and continually reduced with appropriate measures, through multi-disciplinary co-operation including the customer and suppliers.


• Customer requirements/performance specifications

• Function, safety, reliability, maintainability, important characteristics


• Involvement of all affected areas

• Trial and test results

• Product-specific measures from the process risks

Amendments to the product and process must be evaluated by the project management. In agreement with the team, a new analysis (if necessary) is to be initiated. An update is also necessary after realisation of measures (Design Review).



• Important parameters/characteristics, legal requirements

• Function, fitting measurements

• Material


• Transport (internal/external)

The quality plan must contain components, subassemblies, assemblies, parts and materials, including the production process from pilot production phase, which belong to the product. The quality plan is a living document and must be raised/updated for new or amended products. A quality plan should generally be raised for the following phases:

Prototype phase (if required by the customer) or description of the dimensional, as well as material and functional inspections, which are to be carried out during the construction of the prototype. Interface to process development, description of the dimensional, as well as material and functional inspections, which are to be carried out after construction of the prototype and prior to serial production.

It must give details regarding, amongst other factors, the following:

• Establishing and marking of significant characteristics

• Raising of an inspection and test plan

• Provision of equipment and fittings - timely, planned provision of measuring equipment

• Inspections at appropriate points during the production

• Clarification of acceptance criteria

Is the risk document prepared in teamwork?

Have historical concern data been reviewed?

Have significant characteristics been identified?

Are the risks reviewed/updated in case of product modifications?

Are product validation concerns and results fed back into the risk tool?

Have corrective actions been completed and verified?

Is the quality plan maintained and up to date?

Does the quality plan itemise all tests and checks?

Are related working and inspection instructions clearly linked?

Are all process and control points accurately detailed?

Does the quality plan include supplied material and sub-contracted processes?

Does the quality plan list designated characteristics?


Element/Generic Audit Question



2.4 ARE THE REQUIRED RELEASES/DESIGN VERIFICATION RECORDS AVAILABLE AT THE RESPECTIVE TIMES?

2.5 ARE THE REQUIRED RESOURCES AVAILABLE?

The releases/design verification records of all individual parts, subassemblies and purchased parts are to be proven.


• Product trials (such as fitting inspections, functional tests, durability checks, environmental simulations)

• Status of the prototype parts

• Pilot series model

• Production/inspection, measuring and test equipment in experimental installation

The required resources are to be taken from the quotation calculation and the pre-planning. They must be available, or planned and provided at the respectively appointed time. The required means for this must be included in the project.




• Lost time through absenteeism

• Throughput/processing time


• Experimental installation

• Prototype construction

• Tools/equipment


Is the design sufficiently qualified! Are the results properly documented?

• Design verification-test results

• Manufacturing and assembly trials

• Qualification of sub-contracted components

• Inspection and test equipment

Are the results obtained from production intend/ representative parts?

Have non-conformities appropriate corrective actions in place?

Are non-conformities addressed by concern & corrective actions reports (8D-reports)?

Are the corrective actions verified effective?

Are the required resources established and available to provide sufficient support to the project?




3. Element: Process Development Planning

3.1 IS THE MANUFACTURING PROCESS DEVELOPMENT PLAN AVAILABLE?

3.2 HAVE THE PROCESS REQUIREMENTS BEEN DETERMINED AND CONSIDERED?

The manufacturing process development plan is an integral part of the project plan and stands in correlation with the product design plan or could be merged. All activities until start of series are to be determined. The targets must be derived from the requirements and maintained at the established project phases.



• Costs

• Milestones: planning/purchasing release, prototypes/pilot productions, start of serial production

• Resources studies

• Provision of production/testing equipment, software, packaging

• Safeguard concept for amendments (start-up problems etc.)

• Logistic/delivery concept

• Setting and monitoring the target

• Regular information to the company management

The process requirements are to be determined through multi-disciplinary co-operation. Previous experiences and future expectations must be included in the consideration.



• Manufacturing flow charts

• Capability records

• Suitability of plants, tools, inspection and test equipment including requirements relating to sanitisation

• Arrangement of work and inspection stations

• Handling, packaging, storage, marking

• Pest control measures required

Are all specifications available and up to date?

• Product specifications

• Significant characteristics

• Packaging/logistic requirements

• Project timing and milestones

Are the specifications to the latest revision level?

Are legal/environmental requirements known and up to date?

Are the documents controlled, updated and distributed to the relevant functions in case of modifications?

Are the requirements pertaining to the manufacturing process determined?

Has a process flow chart been prepared?

Are Production Data sheets and process validation plans in place to qualify production parts and processes?

• Production validation testing

• Capability studies

• Measurement system studies

• Packaging/transport approval

• Volumes/demands

Are historical problems/concerns and corrective actions taken into consideration?

Are PPM-targets defined?

Is the manufacturing and quality concept communicated and approved?

Has a feasibility study been completed?




3.3 ARE THE RESOURCES FOR THE REALISATION OF MASS PRODUCTION PLANNED?

The required resources should be determined and considered during the quotation phase. After award of contract, the details must be stated precisely. When requirements are altered, the resources study should be updated if necessary. The required means are to be planned and made available.



• Availability of input material


• Lost time through absenteeism/standstill times

• Throughput times/processing times/number of production pieces per plant/equipment


• Plants, tools, production/testing equipment, auxiliary tools, laboratory equipment

• Transport means, containers store

Have the resources needed for process development and mass production been identified and planned?

• Personnel

• Production facilities

• Transport/handling facilities




4. Element: Performing Process Development

4.1 IS A QUALITY PLAN & PROCESS FLOW CHART PREPARED?

4.2 ARE THE REQUIRED RELEASES/QUALIFICATION RECORDS AVAILABLE AT THE RESPECTIVE TIMES?

The quality plan must be in line with the relative process flow of manufacture from receiving of raw material through to despatch. Amendments to product and process must be evaluated by the manager. In agreement with the team a new analysis (if necessary) should be initiated. An update is also required after measures have been realised.



• All production activities, including those of suppliers when processes are subcontracted

• Important parameters/characteristics

• Legislative requirements

• Fitting measurements

• Material

• Traceability


• Transport (internal/external)

The releases/qualification records of all individual parts, subassemblies and purchased parts, production, inspection, measuring and test equipment, must be proven.


• Product trials (such as fitting inspection, functional test, durability check, environmental simulations)

• Pilot production parts

• First sample

• Capability records of important product/process characteristics

• Logistic concept (for example, checking suitability of packaging by a test dispatch)

• Tools, machines, equipment, inspection, measuring and test equipment

Are part & process validation concerns and results fed back into the team?

Have corrective actions been completed and verified?

Are designated characteristics considered sufficiently within the process study?

Are parts and processes sufficiently qualified?

• Production validation testing

• Dimensional results

• Material results

• Capability studies

• Measurement system studies

• Packaging/ transport approval

Is complete Part Approval submission to customer done and are records available?

Are the results obtained from representative Part approval production run?

Have the sub-contracted parts attained full Part approval?

Are non-conformities/deviations from specifications approved by customer prior to Part approval submission (Concession request)?

Are the results properly documented and retained according to required document control procedure?




4.3 ARE THE PRODUCTION AND INSPECTION DOCUMENTS AVAILABLE AND COMPLETE?

4.4 ARE THE REQUIRED RESOURCES AVAILABLE?

Process parameters/inspection characteristics must always be given with tolerances, and the production and inspection documents must be available at the work/inspection station. The implemented corrective actions for non-conformities must be documented.

Details include:

• Process parameters (such as pressures, temperatures, times, speeds)

• Machine/tool/auxiliary means data

• Inspection requirements (important characteristics, inspection, measuring and test equipment, methods, inspection frequencies)

• Intervention limits in process control charts

• Machine and process capability records

• Operating instructions

• Work instructions

• Inspection instructions

• Information on the current non-conformity

The resources required are to be taken from the quotation calculation and the current process development.



• Availability of input material


• Lost time through absenteeism/downtimes

• Throughput times/processing times/number of production pieces per plant/equipment


• Plants, tools, production/inspection equipment, auxiliary tools, laboratory equipment

• Transport means, containers, store

Are the process parameters defined with limits?

Are working and inspections instructions complete, maintained and up to date? Do they carry an issue level?

Are acceptance standards/visual aids complete?

Do all inspection instructions/charts have defined acceptance criteria or limits?

Are diagnosis/rework instructions complete? Are set instructions complete?

Are golden samples/test facilities prepared to verify correct function of poke yoke/testing devices prior to production start?

Are all organisational measures (including material, training, production area, and equipment) complete in order to ensure a fault free production start?

Has production readiness been assessed? (Launch Readiness Review/Run @ Rate)




5. Element: Suppliers/Input Material

5.1 ARE ONLY APPROVED QUALITY CAPABLE SUPPLIERS USED?

5.2 IS THE AGREED QUALITY OF THE PURCHASE PARTS GUARANTEED?

5.3 IS THE QUALITY PERFORMANCE EVALUATED AND ARE CORRECTIVE ACTIONS INTRODUCED WHEN THERE ARE DEVIATIONS FROM THE REQUIREMENTS?

5.4 ARE TARGET AGREEMENTS FOR CONTINUAL IMPROVEMENT OF PRODUCTS AND PROCESS MADE AND IMPLEMENTED WITH THE SUPPLIERS?

Prior to determining the suppliers, an evaluation of the quality system (certification/auditing) must be available. During mass application, it must be ensured that only suitable suppliers are used. Experiences from quality performance assessments must be considered.


• Supplier discussions/regular support

• Evaluation of the quality capability, for example supplier audit results/certificates

• Assessment of the quality performance (quality/costs/service)


• Sufficient inspection and test possibilities (laboratory and measuring equipment)

• Internal/external inspections and tests

• Supplied gauges/surveys

• Drawings/order details/specifications

• Quality assurance agreements

• Co-ordination of inspection and testing procedures, proceedings and frequencies

• Analysis of nonconformity focal points

• Capability evidence


• Workshops (inter-disciplinary working groups)

• Establishing measurable target parameters for quality, price, service

• Reducing the inspection and testing magnitude while increasing process safety

• Reducing rejections (internal/external)

• Reducing the stock in circulation

• Increasing customer satisfaction

The capabilities and performance of a supplier are to be checked at defined intervals and recorded. This data is used for the re-evaluation of suppliers. Corrective action programmes should be established when negative results are found. The implementation must be proven.


• Records about quality meetings

• Agreements about and monitoring of improvement programmes

• Inspection and measuring records of improved components

• Analysis of nonconformity focal points/problem suppliers

Are the suppliers certified to ISO 9001?

Are process audits carried out on the supply base?

In case of deficiencies, are corrective actions determined and followed up?

Are the quality requirements agreed with the supplier in a purchase order, including drawings, specifications, acceptance standards, significant characteristics, and testing methods?

Are the specifications to the latest revision level? Are adequate sampling plans in place?

Are results properly documented with sufficient detail and linked to material batches?

In case of non-conformities, are containment and corrective actions in place to provide 100% OK parts?

Is supplier performance measured against agreed targets?

Is the quality performance of suppliers monitored?

Are appropriate supplier development activities in place to improve quality performance?




5.5 ARE THE STOCK LEVELS OF INPUT MATERIAL MATCHED TO PRODUCTION NEEDS?

5.6 ARE INPUT MATERIALS DELIVERED AND STORED ACCORDING TO THEIR PURPOSE?

5.7 ARE PERSONNEL QUALIFIED FOR THE RESPECTIVE TASKS?

The required stock levels must already be considered and determined during process planning. When requirements change, the analysed stock levels should be updated if necessary.



• Just in time

• Storage costs

• Emergency strategy when input material bottlenecks occur

• FIFO (first in/first out), expiry date movement of stock

• Pest control measures and sanitization with respect to storage of material


• Packaging

• Storage administration system

• FIFO (first in/first out)

• Tidiness and cleanliness

• Climatic conditions

• Protection against damage/contamination

• Identification (traceability/inspection status/sequence of operations/application status)

• Safety against mix-ups

• Secure storage (fitted and used)

Personnel responsible for the following areas should be considered:

• Supplier selection, evaluation, qualification

• Product inspection, measuring and testing

• Storage/transport

• Logistics. For example, personnel must be knowledgeable about:

• Product/specifications/special customer requirements

• Standards/legislation

• Packaging

• Processing

• Evaluation methods (such as audits)

What are customer volume requirements?

Are backup plans in place in case of bottlenecks?

Are safety stocks in place in case of long or risky supply chain?

Are the packaging, handling and storage of input material appropriate to protect from damage?

Are climatic constraints and cleanliness requirements respected if applicable?

Does the stock management ensure FIFO, traceability information and prevention of parts being mixed up?

Are sufficient sanitisation and pest control measures in place?

Does the stock management ensure that nonconforming or obsolete material is not used? Is there a suitable quarantine area?

Is rejected material traced to reason for rejection, date and corrective actions?




6.1 Element: Personnel/Qualification

6.1.1 ARE THE EMPLOYEES GIVEN RESPONSIBILITY AND AUTHORITY FOR MONITORING THE PRODUCT/PROCESS QUALITY?

6.1.2 ARE THE EMPLOYEES GIVEN RESPONSIBILITY AND AUTHORITY FOR PRODUCTION EQUIPMENT AND ENVIRONMENT?

6.1.3 ARE THE EMPLOYEES SUITABLE TO PERFORM THE REQUIRED TASKS AND IS THEIR QUALIFICATION MAINTAINED?

6.1.4 IS THERE A PERSONNEL PLAN WITH A REPLACEMENT RULING?


• Co-operation on improvement programmes

• Worker self assessments

• Process approval/release

• Set up release (first/last production piece testing)

• Process control (interpretation of quality plans)

• Authority to stop production



• Carrying out or ordering repair and maintenance work

• Providing parts/storage

• Carrying out/ordering the installation and calibration of inspection, measuring and test equipment.


• Introduction/training/qualification records about the process

• Knowledge of the product and non-conformities which have occurred

• Instructions in health and safety at work, or environmental aspects

• Instructions on the handling of “components with special verification requirements”

• Qualification records such as certificates, sight tests, driving license for industrial trucks

When planning personnel, the absentee figures (illness/holidays/training courses) should be considered. The required qualifications of replacement personnel must be ensured.


• Shift plan (contract related)

• Qualification records (skills matrix)

• Work analyses/time and motion studies

Are manufacturing personnel qualified to monitor and judge product/process quality?

Are personnel prepared to take appropriate actions in case of problems or non-conformities?

Are production personnel qualified and tasked to take care of first level maintenance, cleanliness and tidiness at work places?

Do personnel have the necessary skills and authority, and do they practise it?

Are personnel trained to perform the required tasks?

Are there appropriate training plans against required qualifications in place?

Does personnel planning ensure that sufficiently trained personnel are available for each process step?

Is there a skill matrix demonstrating that all shifts are trained sufficiently?



6.2.3 ARE THE WORK AND INSPECTION STATIONS APPROPRIATE FOR THE NEEDS?

The environmental conditions (including repairs and rework) are to be tuned to the work contents and the products, to avoid contamination, damage and mix-up/misinterpretation.


• Ergonomics

• Lighting


• Environmental protection

• Surroundings/handling of the components

• Health and safety at work

• Sanitisation and pest control measures


6.2 Element: Production Material/Equipment

6.2.1 ARE THE PRODUCT-SPECIFIC QUALITY REQUIREMENTS FULFILLED WITH THE PRODUCTION EQUIPMENT/TOOLS?

6.2.2 CAN THE QUALITY REQUIREMENTS BE MONITORED EFFECTIVELY DURING MASS PRODUCTION WITH THE IMPLEMENTED INSPECTION, MEASURING AND TEST EQUIPMENT?


• Machine/process capability evidence of important characteristics/process parameters

• Compulsory control or regulation of important parameters

• Warnings such as lamps, sirens or shutdown when deviations from specified values occur

• Feed and delivery equipment

• Maintenance and repair status of tools/plants/machines (including scheduled maintenance)


• Reliability, function and corrosion resistance tests

• Measuring accuracy/inspection, measuring and test equipment capabilities

• Data acquisition and analysis

• Calibration records

Is the manufacturing equipment in a condition and maintained to provide stable quality?

Are maintenance instructions in place, are activities carried out to plan and documented?

Are process parameters defined and controlled to ensure stable production?

Does the process provide safe failure prevention/detection?

Does the process ensure that nok/suspect parts are not slipping through?

Are the required inspection & testing facilities in place?

Are they suitable to control the quality characteristics?

Are inspection & testing facilities calibrated and maintained?



6.2.5 ARE THE REQUIRED CORRECTIVE ACTIONS CARRIED OUT ON SCHEDULE AND CHECKED FOR EFFECTIVENESS?


6.2.4 ARE THE RELEVANT DETAILS IN THE PRODUCTION AND INSPECTION DOCUMENTS COMPLETE AND MAINTAINED?

Process parameters and inspection and testing characteristics must always be given with tolerances. Manufacturing and inspection documents must be available at the work/inspection stations. Non-conformities and implemented corrective actions must be documented.


• Process parameters such as pressures, temperatures, times, and speeds

• Machine/tool/auxiliary means data (tool and machine numbers)

• Inspection requirements (important characteristics, inspection, measuring and test equipment, methods, frequencies)

• Operating instructions

• Work instructions

• Inspection instructions

• Information on the current non-conformities

Corrective actions relate to the entire process chain, from input material through to use by the customer. The effectiveness of corrective actions carried out must be checked and proven.


• Improvement programmes from audits

• Information to the responsible party

• Interface discussions internal/external

• Internal complaints

• Customer complaints

• Customer surveys

Are clear, concise work & inspection instructions accessible at each work station?

Are the instructions maintained and to the latest revision level? Do they reflect concerns?

Are the instructions suitable and understandable?

Are they assisted by visual aids where appropriate?

Are acceptance standards/limits clearly defined?

Do non-conformities detected immediately lead to containment and corrective actions to prevent parts from being delivered?

Are suspect parts checked downstream?

Are risks and internal/external concerns recovered by appropriate corrective actions?



6.3.2 IS THE MATERIAL AND PARTS FLOW SECURED AGAINST MIX-UPS OR EXCHANGED BY MISTAKE, AND TRACEABILITY GUARANTEED?

Appropriate to the product risk, traceability must be guaranteed along the entire process chain from supplier to customer.


• Identification/marking of parts

• Identification/marking of the operational, inspection and test and application status

• Batch/heat numbering

• Expiry date

• Removal of invalid identification/marking

• Working documents with parts/production data

Does the management of internal handling and storage ensure that traceability is not lost?

Is the material correctly identified by p/n, rev. level, WIP status, production date, or batch number?

Does the internal material management ensure FIFO?


6.3 Element: Transport/Parts Handling/Storage/Packaging


6.3.1 ARE REJECTS, REWORK AND ADJUSTMENT PRODUCT STRICTLY SEPARATED AND IDENTIFIED?


• Holding store, holding areas

• Marked containers for rejects, rework parts and adjustment parts

• Non-conforming products and non-conformity characteristics

• Identification/marking

• Defined transfer/rework stations in the production department

Does the handling and processing of non-conforming parts ensure that they can’t slip through?

Are rejected parts properly identified and segregated? Are they traced for reject reason, date and corrective action?

Are appropriate reject bins placed at each work station?

Is there an appropriate quarantine area? Are reworked parts marked or identified?

Are reworked parts subject to re-inspection?



6.4 Element: Fault analysis/Correction/Continual Improvement


6.4.1 ARE QUALITY AND PROCESS DATA RECORDED COMPLETE AND READY TO BE EVALUATED?

6.4.2 ARE PROCESSES AND PRODUCTS REGULARLY AUDITED?

6.4.3 ARE PRODUCT AND PROCESS SUBJECT TO CONTINUAL IMPROVEMENT?

Quality and process data must be completely available to prove compliance with requirements. Data must be able to be evaluated. Special events are to be documented.


• General charts, Non-conformity lists and Control charts

• Data acquisition

• Records of process parameters (such as temperature, time, pressure)

• Plant downtime

• Parameter changes

• Power cuts

Audit plans for the product and its manufacturing process must be available. Audit reasons are, for example:

• New projects/processes/products

• Non-conformity with quality requirements (internal/external)

• Maintaining records of the compliance with quality requirements

• Identifying improvement potential

• Non-conformity reports (NCRs) are to be distributed to the responsible parties and the improvement measures must be monitored



• Important characteristics

• Function

• Process parameters/capabilities

• Marking/identification, packaging

• Established processes/procedures

The improvement potential must be determined from previous findings about quality, costs and service.


• Cost optimisation

• Reduction of waste (for example rejects and rework)

• Improvement of process safety (such as process analysis)

• Optimising set-up times, raising plant availability

• Reducing throughput/processing times

• Reducing stock levels

Is there an internal audit procedure that covers product audits and system audits?




6.4.4 IS THERE A DEFINED DOCUMENTED PROCESS TO HANDLE CUSTOMER COMPLAINTS AND WARRANTY CLAIMS?

6.4.5 ARE TARGET PARAMETERS AVAILABLE FOR PRODUCT AND PROCESS AND IS THEIR COMPLIANCE MONITORED?

The procedure to handle customer complaints must provide requirements for the following:

Process to document warranty and customer complaints - is there a registering system? Also time frame to respond to customer complaints and warranty claims.

Does the organisation determine the root cause of the problem? If so, describe the system used. Once corrective action is taken, is there a verification process to ensure effectiveness? Is there a recall process when investigation indicates a high probability of critical product failures in the field?

Target parameters must be agreed and feasible, the topicality is to be guaranteed. Special measures required must be established and implemented, if necessary.


• Presence and absence of personnel

• Number of production pieces produced

• Quality indices such as failure rates or audit results

• Throughput/processing times

• Non-conformity costs

• Process characteristic values (process capability for example)



7. Element: Quality Management System


7.1 ARE KEY PROCESSES FOR A QUALITY MANAGEMENT SYSTEM DOCUMENTED?

7.3 ARE RESPONSIBILITIES AND AUTHORITIES FOR THE QMS CLEARLY IDENTIFIED?

7.2 IS THERE A DOCUMENTED QUALITY MANUAL CONTAINING QUALITY POLICY AND REFERENCE TO THE REQUIRED PROCEDURES?

The organisation needs to identify and map key and supporting processes of its system.


• Sales Process

• Design Process

• Manufacturing Process

Responsible personnel for the following areas should be considered:

• Top management

• Management responsible for Quality Management System


• Quality Policy indicating the top management commitment to quality

• Reference to the procedures such as:

• Document control

• Control of Quality Records

• Internal Audits

• Corrective Action addressing customer complaints

• Preventive Action

Are all processes of the QMS identified and documented?

Document procedure must describe manner of control such as revision numbers, date of issue, and so on.

Records procedure must indicate storage time, method and disposition of records. Internal audit procedure must indicate how audits are planned and conducted.


quality development audit - sabs quality development audit guide element/generic audit question...

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