Definition:
Quality system/(Quality management system) (according to DIN EN ISO 8402/3.6):
The organizational structure, responsibilities, procedures, processes and re-sources needed to implement quality management.
Requirements/Explanation:
The quality system extends to all phases of the life cycle of a product (DIN EN ISO 9004-1 Paragraph 5.1) and all value-adding processes invol-ved. It’s interacting functions are a precondition for the continuous com-pliance with the requirements of customers, legislators and society.
A universal understanding of quality and quality assurance should extend as a „leading theme“ throughout the entire company. The understanding of quality management as a task of all employees can be demonstrated by, for example:
- actions including various departments
- appropriate training, presentations, publications - department-related objectives for quality improvement - responsibilities matrices.
Job descriptions and organization charts serve, among other things, to endorse employees, clarify relationships at interfaces and provide evidence of relevant duties. They make the organization transparent, simplify person-nel qualification and assignment and promote motivation and enthusiasm for decision-making.
02.3* Are there documented procedures defining duties, responsi-bilities and authority levels for quality activities?
Explanation of terms:
„Activities affecting quality“ relate both preventatively and reactively to the entire life history of a product.
"Quality documented procedures" are special stipulations which are necessary for the fulfillment of the defined quality-related activity. They come into effect when signed.
Requirements/Explanation:
Duties, responsibilities and authorities are to be unambiguously and clearly defined for those departments and employees which influence product and process quality. Thereby, coordination and interfaces between various de-partments and activities must be observed.
These definitions are best made, for example, in:
- Quality documented procedures - Responsibility matrices
- Job descriptions,
which come into effect when signed. Hereby, it must be ensured that duties are clearly defined with the necessary independence to fulfill stipulated requirements. This requires a definition as to who, for example:
- can stop faulty products or processes
- is responsible for suggesting and monitoring problem solutions - monitors conformity with quality requirements, particularly after
changes
- is responsible for quality-relevant documentation.
02.4* Is there a cross-functional project management established which includes the quality planning process?
Explanation of terms:
„Project management“ is defined as the management of activities across several departments within a company, aimed at the realization of a particu-lar project (e.g. introduction of a new product [see Question 08.1], a new process, start of a series [see Element 14]). This task begins as early as possible and encompasses the concept/design phase, the manufacturing process, through to product utilization and disposal. It includes, among other things, quality planning (see Question 02.5) and the quality plan (see Question 02.6).
Requirements/Explanation:
Project flow charts with the main details, among other things for the mana-gement of a project, must be raised and developed at a very early stage.
Here, the joint activities include:
- raising the specification - concept / design, - development - production - utilization - disposal
which must be outlined and explained in the context of simultaneous engi-neering taking interface issues into account. Quality methods (such as QFD, DFMEA, PFMEA, DOE,...) must be applied on a project-specific basis.
Depending on the task, the project team should include staff from De-velopment, Production Planning, Quality and Production departments etc.
The Purchasing department and suppliers must be included when neces-sary.
The duties and responsibilities must, for example, be defined in project plans or respectively, in product and process development plans. The appointment of a project representative (project manager) is advantageous for all projects. In the case of new projects, it must be ensured that confidentiality, protection and security of data is guaranteed through appro-priate procedures for those involved in the project. Suppliers, if necessary, are also be included.
Note: The requirement for a "Configuration management" in the standard DIN EN -ISO 9004-1, Section 5.2.6 and 8.10, is interpreted as "Project management " in this questionnaire (also see DIN 69905[12.90] - Project implementation).
02.5* Is there a quality planning process for the necessary measu-res and procedumeasu-res for fulfilling quality requirements?
Definition:
Quality planning (acc. to DIN EN ISO 8402/3.3): activities that establish the objectives and quality requirements, as well as the requirements for the application of the elements of the quality system.
Note: Quality planning covers:
a) product planning: identifying, classifying and weighting the characteristics for quality, as well as establishing the objectives, quality requirements and straints;
b) planning managerial and operational activities: preparing the application of the quality system including operational and time schedules;
c) the preparation of quality plans and the making of provisions for quality improvement.
Requirements/Explanation:
Quality planning (also known as advanced quality planning) must be regarded as an interdisciplinary task which defines how the quality require-ments should be fulfilled. It must be compatible with the quality elerequire-ments of the company and match the size, structure and working methods used (e.g.
through reference to appropriate procedures/already existing planning sche-dules or descriptions).
Quality planning must take into account the tasks and deadlines stipulated by the customer and must contain specially defined methods.
Interdisciplinary teams must be used for the activities to be carried out (e.g.
Product Development, Process Planning, Quality, Marketing).
The quality planning phases for new products are:
• Planning and definition
- Determining the customer's requirements and expectations - All activities must be carried out from the view of the customer
(end user, consumer).
- Input data and results can vary
- The stated input data and results represent recommendations.
• Product design and product development, including verification - The quality planning team responsible for the product must
consider all development aspects in the planning process in order to ensure that the end product meets the customer's expectations.
- If the design responsibility lies with the customer, design aspects must also be considered.
• Process design and process development, including verification - Development of a process system with the quality plans to be
used
- The process system must ensure that the requirements, needs and expectations of the customer are met.
• Process and product validation
- The production process must be validated by evaluating a trial series.
- The quality planning team responsible for the product should verify that the quality plan and the process plan are fulfilled and that the products meet the customer's requirements.
• Feedback, evaluation and corrective measures
- The results of the trial series have to be evaluated to ensure that the products meet the customer's requirements.
- The effectiveness of the product quality planning process must be newly evaluated
Activities include, for example,:
- Definition and identification of significant characteristics (tailored to the customer's stipulations)
- Development and review of risk analyses (e.g. FMEAs) and the resulting measures.
- Development and review of quality plans (see Question 02.6) - Determining the required resources (e.g. personnel, production
equipment, measuring systems) - Clarification of acceptance criteria
- Examination of the realization of the process - Determining manufacturing feasibility/practicality
(see Question 07.2)
02.6* Are there quality plans resulting form the quality planning process?
Definition:
Quality plan (according to DIN EN ISO 8402/3.13):
A document in which the specific-related work instructions and aids, as well as the sequence of activities with regard to an individual product, an indivi-dual project or an indiviindivi-dual contract, are outlined.
Note 1: A quality plan normally refers to those parts of the quality manual which apply in a specific case.
Note 2: An alternative description, e.g. "quality assurance plan" can be used, depending on the area of application of the plan.
Depending on the customer’s requirements and company practice, a quality plan can be an independent document or the relevant stipulations are incor-porated into a different document, such as, for example, in a project plan.
Requirements/Explanation:
The quality plan must normally be drawn up for the following 3 phases:
• Prototype phase
A description of the dimensional, material and functional inspections and tests which must be carried out during prototype construction (when required by the customer).
• Pre-series phase
A description of the dimensional, material and functional inspections and tests which must be carried out after prototype construction and before series production.
• Series phase
Comprehensive documentation of the product and process characte-ristics, the process control measures, the inspections and tests and measuring systems which must be observed during series produc-tion.
When quality plans are drawn up, a distinction is made between various versions. These are related to tangible products in
a) plans for a part manufacturing process with, for example, the following content:
• Part name
• Process plan (manufacture / inspection / storage)
• Process stages (working steps)
• Work instructions
• Identification of the quality-relevant characteristics which have to be monitored during production.
• Process monitoring - Process description
- Monitoring methods (quality control charts, automatic recor-dings etc.)
- Responsibilities (operator inspection, quality inspection etc.) - Inspection instructions
• Inspection
- Parameters
- Geometric/material/functional characteristics
• Documentation,
b) plans for a finished product with, for example, the following content:
• Responsibilities (organizational units)
• Review of the customer requirements
• Contract review
• Design review
• Production
• Product inspection and testing including
• Associated management plan
• Design and development plan
• Product quality plan for purchased products
• Manufacturing plan (provision of machines, tools, equipment, testing and inspection equipment)
• Control plan (see Question 15.1)
• Service plan
If required, the quality plan must be agreed upon with the customer.
Quality plans are living documents and must be reviewed and updated if:
- the product has been modified - the processes have been changed
- the processes are no longer stable or capable
03 Internal Quality Audits
DIN EN ISO 9001, Section 4.17 DIN EN ISO 9004-1, Section 5
No organizational measure, or quality system procedure, works automatically when it is put into place. It requires constant devel-opment and monitoring.
Internal quality audits carried out by trained and qualified staff serve the purpose of systematic and continuous review as to whether the activities defined in the quality system and their re-sults:
- actually meet the requirements
- are suitable for achieving the objectives and - demonstrate improvement possibilities (CIP – continual improvement process)
All the elements, aspects and components of a quality system should be regularly subjected to internal reviews (internal quality audits). The audit results shall be presented to management for their review in documented form and, if necessary, should lead to corrective actions being implemented.
Audit reports are quality records.
An internal audit encompasses all quality elements and thereby provides the objective evidence about the necessity for the reduc-tion, elimination and, most importantly, the prevention of noncon-formities.
Note: VDA Volume 6.3 and 6.5 are also applicable for this element.
Reference DIN EN ISO 9001 9004-1 03.1
*
Are the personnel (auditors) who perform internal quality audits qualified and independent of the areas being audited?
4.17 5.5
03.2
*
Are all elements of the quality system regularly subjected to internal audits and evaluated according to an audit plan?
4.17 5.4
5.5
03.3
*
Do deviations lead to corrective actions and are these documented?
4.17 5.4.5
03.4
*
Are the demands placed on products and processes audited and evaluated internally on the basis of an audit
- 5.4.3
03.1 * Are the personnel (auditors) who perform internal quality audits qualified and independent of the areas being audited?
Definition:
Quality auditor (according to DIN EN ISO 8402/4.11):
Person qualified to perform quality audits.
Explanation of terms:
"Quality auditors" (see DIN ISO 10011, Part 2) must be impartial and free from any influences which might affect their objectivity.
Personnel tasked with carrying out audits must be independent of the areas on which they are reporting. They must not come from the organizational unit to be audited.
Requirements/Explanation:
Auditors must be qualified to manage and perform internal quality audits.
The required qualification profile must be defined. Depending on the type of audit and size of the company , the following aspects are particularly relevant:
• Qualification in accordance with DIN ISO 10011-2 and training in accordance with EOQ or equivalent guidelines. Evidence of training can also be supplied through internal training courses.
• Knowledge and understanding of the standards which might form the basis for audits of quality systems (DIN EN ISO 9000 - 9004, VDA Volume 6, Part 1)
• Evidence about the methods of grading through investigation, interview, evaluation and reporting (e.g. auditor training in accordance with VDA 6.1)
• Skills that are essential for the management of a quality audit, such as planning, organization, communication and leadership
• Experience in quality management and quality techniques
• Personal characteristics, such as, e.g. integrity, good judgement,
03.2* Are all elements of the quality system regularly subjected to internal audits and evaluated according to an audit plan?
Explanation of terms:
The different types of audits with scheduled dates and the areas to be audited have to be defined in an „audit plan“ (according to DIN ISO 10011-1). This auditing is the systematic review of all quality elements with regard to their effectiveness, compliance with the requirements and their topicality.
Requirements/Explanation:
System audits must be planned and carried out.
Audit plans tailored to the quality elements to be audited must be available in the organizational units.
An audit plan must contain the following information:
- Reference documents (standards, quality manual, procedures, etc.)
- Areas and quality elements to be audited - Audit sequence
- Questionnaire / checklist - Scheduled dates
- Auditors / audit team
After completion of an audit, an audit report with the nonconformances found and suggested corrective actions is to be raised. It is to be distributed to the organizational units involved in the audit and the company manage-ment. The effectiveness of the corrective actions is to be evaluated within an appropriate period of time (see also Question 01.6).
Individual quality elements or parts thereof can also be inspected and eva-luated at different times. All quality elements, in all areas, and at all com-pany sites must be audited within 3 years.
03.3* Do deviations lead to corrective actions and are these docu-mented?
Definition:
Corrective action (in accordance with DIN EN ISO 8402/ 4.14)
An activity carried out to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent it’s recurrence.
Requirements/Explanation
Detected deviations must lead to immediate corrective actions, i.e. remedy-ing the cause of one or more nonconformances.
A plan of action must be presented within an agreed time regarding the deviations and proposed corrective actions. The action plan contains, for example:
a) Deviations
- Non-compliance with a requirement of a standard - Instructions are not suitable to achieve the objective - Activity does not correspond to the instructions - Instructions not actually implemented
b) Evaluating / weighting deviations with respect to - Image
- Risk/product safety - Economy
c) Remedial measures d) Responsibilities/deadlines e) Effectiveness check
03.4* Are the demands placed on products and processes audited and evaluated internally on the basis of an audit plan?
Explanation of terms:
A "product audit" serves to assess the compliance of the workmanship with the defined quality requirements on the product after the final inspection.
A "process audit" serves to check whether the product complies with the quality requirements and that the process is mastered and capable.
Requirements/Explanation
Product and process audits must be planned and carried out
Audit plans must be defined for products and processes and must include the following information:
- Audit aim
- Reference documents
- Products/processes to be audited - Audit sequence
- Questionnaire/checklist - Deadlines
- Auditors
- Reporting with distribution list - Pursuit of corrective measures
After completion of an audit, an audit report with the nonconformances found and suggested corrective actions is to be raised and issued to the involved parties. The effectiveness of the corrective actions is to be evalu-ated within an appropriate period of time (see also Question 01.6).
The appropriateness of the working and ambient conditions should also be examined during these audits (see Question 14.6).
04 Training
DIN EN ISO 9001, Section 4.18 DIN EN ISO 9004-1, Section 18
The employees utilized in a company are an essential factor con-tributing to the quality capability of that company. In order to achieve this, measures to train, qualify and motivate employees should be planned and implemented for employees in all areas and at all levels of the company.
Reference DIN EN ISO 9001 9004-1 04.1 Are training requirements regularly determined
on an individual and function-related basis and is a differentiated training program for all levels of the company derived from this?
4.18 18.1.1
04.2 Does the training program also include actions for further training in quality techniques?
4.18 18.1.1
04.3 Are top management and other management staff included in the vocational training program?
Are there introduction and instruction pro-grams for new and transferred employees and for the introduction of new or modified pro-cesses, business procedures etc.?
4.18 18.1.3
04.5
*
Do employees possess the formal qualification for their activities?
4.18 18.2
04.6 Are there measures for the motivation and promotion of quality awareness?
18.3.1
04.7
*
Do clear and understandable representations of the achieved quality compared to the set objectives exist in the company?
18.3.4
04.1 Are training requirements regularly determined on an