Explanation of terms:
"Procedures to contain nonconforming items" serve damage limitation.
They facilitate the traceability of products in a manufacturing operation back to the material and processes used.
Requirements/Explanation:
Emergency plans for product recalls must be defined commensurate with the product risks, which are derived from the safety relevance of a product and possible risks in the entire process chain.
Procedures to contain nonconforming products (see also Questions 11.7 and 13.6), for example, can be:
- Identification on the part/product - Lot/batch identification
- Product verification, documentation
- Product identification during transport and storage - Following the "first-in/first-out" principle
- Stating and observing use-by dates
Recognized nonconformities which are relevant to safety can thereby be limited (damage limitation) in the field (during use) and possibly remedied by improvement or recall actions.
Z1 Corporate Strategy
Improved and constant quality, delivery reliability in the agreed time frame and cost reductions on the one hand, plus more inten-sive confidence-building customer/supplier relationships on the other hand, in addition to stronger international business relation-ships, today force many companies to adapt their strategy to these requirements. Company management, including immediately sub-ordinate executive level, must therefore concern itself with the following subjects, e.g.:
- Business plan - Comparison of internal and - Business results external performance data - Customer satisfaction - Employee satisfaction
Note: Characteristic figures and trends, but not absolute values/amounts, must be proven to the external auditor.
Reference DIN EN ISO 9001 9004-1 Z1.1 Is there a strategic business plan in the
company which contains aspects relating to costs, sales, quality etc.?
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-Z1.2 Are there methods to measure business results and are they used regularly in order to introduce improvements?
-
-Z1.3 Is company-wide performance data compared with results from benchmarking or similar methods and are improvement measures derived from this, if necessary?
-
-Z1.4
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Is there a procedure which enables customer satisfaction to be measured and changes to be detected?
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-Z1.5 Is employee satisfaction in the company one of the principles of management and is it maintained on a continuous basis?
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-Z1.1 Is there a strategic business plan in the company which contains aspects relating to costs, sales, quality etc.?
Definition of terms:
A "business plan" is a document with company-specific strategic projects and targets which must be fulfilled or achieved in a defined period.
Requirements / explanation:
A business plan normally includes the following:
a) Cost aspects
- Finance and cost planning (investments, personnel and material costs)
- Cost targets
b) Salevda-0s and marketing aspects - Market data
- Turnover/sales targets
- Customer satisfaction criteria (see Question Z1.4) c) Overall corporate aspects
- Growth projects - Plant structure plans - Personnel planning
- Comparison with other companies (benchmarking) d) Development aspects
- Development and trial projects
- Product analyses of competition results e) Process and quality aspects
- Important characteristic data of process performances - Important quality related figures (see Question 01.2)
All aspects should:
- have time details
- be based on project-related knowledge
- take into account present and future customer expectations - be understandable and monitored, and adapted to any
changes
- serve the purpose of process and quality improvement
Business planning activities must be carried out on an interdisciplinary basis Note: External auditors are to be provided with evidence of : characteristic figures,
time frame, tendencies, trend analyses but not absolute values/amounts and also not for all aspects. Attention must be paid to company-specific matters.
Z1.2 Are there methods to measure business results and are they used regularly in order to introduce improvements?
Definition of terms:
The "business result" expresses what the company achieves with respect to it’s planned performance.
Requirements/Explanation:
Starting points for financial variables can be, for example:
- Profit − Capital
- Cash flow − Liquidity
- Turnover − Dividends
- Value added shareholders − Long-term value for (shareholder value)
In practice, these values are shown partly as absolute values and partly as ratios per capital unit or per employee.
Starting points for non-financial variables can be, for example:
- Market share − Variability of products - Rejects achieved − Customer service level
Cycle times such as:
- Innovation time
- Time until the profit threshold is reached - Stock turnover frequency
The measured variables are orientated towards the company strategy and to the corporate aims and plans. They contain measured variables which enable the internal economy and effectiveness to be recognized and which are decisive for continued corporate success.
Note: Only the existing system must be evaluated, not the absolute values / amounts themselves.
Z1.3 Is company-wide performance data compared with results from benchmarking or similar methods and are improvement measures derived from this, if necessary?
Requirements/Explanation:
The evaluation, analysis and use of company-wide performance data in comparison with the data of competitors or other companies through benchmarking must give information on, for example:
- Productivity - Economy - Quality situation - Efficiency
Trends in the data and information should be compared with the progress made towards the company's overall targets and converted into useable information for the purpose of:
- development of priorities for the rapid solving of customer-related problems
- determining the important customer-related trends and inter-relationships in order to make a review of the company's
Z1.4* Is there a procedure which enables customer satisfaction to be measured and changes to be detected?
Requirements/Explanation:
The procedure must consider the following criteria, e.g.:
- Method application - Recognition frequency
- Data evaluation and representation - Interpretation of trends
- Responsibility - Distribution list
Measurable variables can be, amongst others:
- Flexibility regarding inquiries to new/changed products/
processes
- Achievement of targets - Product quality at delivery
- Delivery reliability (see Question 19.6)
- Speed of reactions when quality problems occur
Comparisons with competitors and benchmarking methods are helpful. As far as possible, not only the direct customer but also the end consumer should be involved.
Measures which lead to greater customer satisfaction should be derived from the knowledge gained.
Note: Only the existing system must be evaluated, not the absolute values/ amounts themselves.
Z1.5 Is employee satisfaction in the company one of the principles of management and is it maintained on a continuous basis?
Definition of terms:
"Employee satisfaction" is measured by the way the employees perceive their company. The needs and expectations of employees must be satisfied by a comprehensive quality approach, in order to advance the employees readiness to work well.
Requirements/Explanation:
Points which effect employee satisfaction are, e.g.:
- Working conditions, work location, environment, equipment - Health and safety measures
- Communication on an individual and company-wide level - Employee performance evaluation, agreed goals, career
planning
- Knowledge of work requirements
- Knowledge of quality policy and corporate strategy - Involvement in quality matters
- System for recognizing and rewarding performance - Management style
- Job security
Further indicators for employee satisfaction can be, for example:
- Results of employee surveys (questionnaire) - Absenteeism and sickness quota
- Personnel turnover
- Ease in hiring recruits/trainees - Use of company facilities
Note: Only the existing system must be evaluated, not the absolute values/
Part P: Product and Process
07 Contract Review, Quality in Marketing DIN EN ISO 9001, Section 4.3 DIN EN ISO 9004-1, Section 7
This quality element deals with the contract review, a marketing duty.
Marketing includes market research, marketing and sales.
The marketing function should take priority when defining the qua-lity requirements of the product. They determine the requirements for a product, the market demand and the customer requirements.
Before a quotation is submitted or a contract or order is accepted, the requirements contained therein are to be checked for com-pleteness, feasibility, ability to fulfill etc. (Contract Review). This applies equally to contract changes.
The requirements of the customer should be documented in a performance specification and should be clearly communicated.
Reference DIN EN ISO 9001 9004-1 07.1 Has a function ‘marketing’ been incorporated
into the process organization?
- 7.1a-c
07.2
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Are inquiries, quotations, contracts/orders checked for completeness and feasibility and approved?
4.3.1 4.3.2
7.1a
07.3 Are technical and commercial costs ascertai-ned when preparing a quotation?
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-07.4 Are the customer's quality requirements on the product and the quality system available?
4.2.3 4.3.2a
7.1d
07.5 Is a procedure available that ensures the early and clear notification of all product specifica-tions to all areas involved?
4.3.2c 7.2
07.1 Has a function ‘marketing’ been incorporated into the