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Welcome to the Elsmar Cove!
ISO 9000 - QS-9000 Information Exchange
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This is circa 1996 - 97
My question - how would YOU answer the following questions about Your company? Note that I'm not saying these are the 'right' answers. As should be obvious, the questions are in BLACK and the 'answers' are in BLUE. The questions are from TUV's audit check list.
A note of caution: Numerous answers have a simple Yes for an answer. Yes as an answer assumes there is a derivative answer such as "It's defined in section 4.6.6 of our systems manual". Answering "YES" in and of itself is totally unacceptable. The idea here is to be able to cite what procedure or other document keys the answer to the question.
Question asked ---> Support Document cited ---> Explanation of system
You should also be quite aware that some questions may in no way apply to your business. This is a non-specific coverall check list. I've started it out. Can YOU finish it for YOUR company?
4.1 Management Responsibility
4.1.1 Quality policy
1. Does any signed fundamental declaration exist, clearly defining the company's quality policy?
The Quality Policy is stated in the company systems manual ('quality manual'). Its approval is by signature of approval of the systems manual.
2. Does the quality policy cover the
- Objectives
From the quality policy,
"... to provide our customers with products and services that meet or exceed their expectations and needs."
" To provide confidence to our customers and distributors that their quality requirements are understood, being fulfilled and maintained."
In addition there is a Quality Objectives statement following the Quality Policy statement in the systems manual.
- Commitments to quality by the upper management?
" This quality policy and quality objectives are supported and driven by management."
3. Is the quality policy relevant for the
- Expectations and
- Needs of the company's customers?
We believe it is relevant and adequate.
4. Is it ensured that information about the quality policy is being distributed within all levels in the company? For example, circulated notices/newsletters, posters, company meetings, training, quality circles, etc.
Company X Chemical is a small company. As such, the communication of the policy is personal. Several quality policy 'posters' are placed at strategic locations around the facility. In addition each employee has a wallet card with the quality policy on it.
5. Is an organizational chart of the company available? Possible ways of presenting the structure of the organization are: e.g. organizational chart, responsibility matrix.
Yes - The organization chart is in the Procedures Manual.
6. Does the organizational chart contain the organizational units responsible to ensure quality?
The organizational chart adequately represents divisions of responsibility. Responsibilities are also defined within company documentation including the systems manual, systems flow charts and other procedural documentation.
4.1.2 Organization
7. Are the holder's of positions in these organizational units identified?
8. Are the
- Responsibility
- Authority
- Organizational freedom
- Interfaces
of personnel who manage, perform and verify work affecting quality defined and documented?
We believe responsibilities are well defined through the organizational chart, the systems manual and other systems documentation.
Authority - Is defined within documentation where appropriate as distinguished from responsibility.
Organizational Freedom - Not particularly applicable to this size of a business.
Interfaces - The size of Company X Chemicals ensures that everyone on every level communicates (interfaces) as necessary without a defined system of interfaces.9. Has a management representative of the supplier's own management been appointed?
Yes. The Vice-President of Operations.
10. Is his responsibility and authority defined in order to ensure that
- The requirements of this standard are implemented,
- The company-specific quality system is maintained,
- The upper management is comprehensively informed about the performance of the quality system?
These are specifically cited and documented in the company systems manual.
4.1.3 Management review
11. How is procedure for the evaluation of the quality system defined, e.g. by
- Goals
"... Continuing suitability and effectiveness. ..."
- Approach
Routine meetings.
- Time intervals?
Yearly as a minimum.
12. Does the upper management review the suitability and effectiveness of the quality system at defined intervals? Based on results of internal quality audits and regarding the status of the achieved quality goals, for example, through customer survey, personnel surveys, quality circle activities as well as by quality reports, customer complaint reports, etc.
Yes. The 'line items' upon which the review is based are itemized on the Management Review form.
13. Does the upper management order necessary corrective and preventive actions and insure its implementation and effectiveness? For example, regarding the quality system, resources, personnel, etc.
Corrective Actions required are identified during management review as a response to systems failures.
14. Are results of management reviews documented and stored?
Yes.
4.2 Quality System
4.2.1 General
1. Does the company have a documented quality system?
Yes - This is defined in the company systems manual.
2. Is the quality system described comprehensively in the quality manual or in other documents?
Yes - In the company systems manual and in other systems documents.
3. Is the structure of the documentation outlined in the quality manual?
Most of the detail is in the system flow charts and related documentation.
4. Are all relevant quality system elements of this standard described?
They are defined as appropriate to Company X Chemicals.
5. Are all quality relevant system procedures included in the quality manual or does it reference the quality system procedures? Based on results of internal quality audits and regarding the status of the achieved quality goals, for example, through customer surveys, personnel surveys, quality circle activities as well as by quality reports, customer complaint reports, etc.
The systems manual contains mainly policy as is typical for 'quality systems' manuals. Within each company systems manual section related documentation is cited. Some detail exists (depending on section) as appropriate to this level of documentation.
6. Has the quality manual been enforced by the upper management?
Upper management monitors to ensure the company systems manual, as well as all other systems documentation, is followed.
4.2.2 Quality system procedures
7. Are the quality system procedures and the derived instructions binding and have they been enforced by the assigned organizational unit? For example, work instructions, inspection instructions.
All documentation within Company X Chemicals is followed and are binding from the date of origin (Company X Chemical's Effectivity Date) to when a procedural document is withdrawn from use in its entirety.
4.2.3 Quality planning
8. Does the company define how quality requirements for products will be met systematically (quality plans)?
A quality plan is, for example, work plan, inspection plan, development plan or upon customer request procedures regarding inspections (kind, scope).Yes. Company X Chemicals utilizes Contract Review and Design Control as the basis of Quality Planning. Most of the items cited in this questions' qualifier extension are in Design Control as Design Outputs which are based upon Design Inputs.
9. Is the scope of the quality system defined regarding
- Plants
There is only one location
- Products (Products can be: industrial product or process, service, hardware and software or a combination of both.
From the systems manual introduction, page 1 " Company X Chemicals, Incorporated is a small business supplying chemical products to automotive Tier 2 suppliers, to the industrial (metal cleaning and phosphating) sector, to institutional (USDA approvals and restaurant) businesses, and to the transportation (truck washing) industry."
- Organizational units?
Organizational 'units' are defined in the organizational chart.
4.3 Contract Review4.3.1 General
1. Does the quality manual contain regulations for the contract review?
Yes - Section 4.3 with additional detail in the Contract Review flow chart.
2. Is the coordination of the activities of involved organizational units defined?
Company X Chemicals is a small company and as such the Vice-President of Operations coordinates contract review including determining who must be involved as appropriate to the contract requirements. This includes whether or not specific meeting(s) are necessary other than general interaction on a day-by-day basis.
4.3.2 Review
3. Are the correct definition of requirements and capability to meet contractual requirements being reviewed before
- Submission of a tender
- Acceptance of a contract or order?
This applies to, for example, product requirements, equipment, fixtures, resources, skills, qualification of personnel, purchased products, quality inspections.Because of the nature of the business as well as the nature of the products (and their intended use), a contract review is not always documented. Contract Review is documented only when a 'non-standard' Request for Quote is received. [Non-standard - new in some way such as ingredients ratios.] If 5 companies are buying cleaner 101, for example, a full-blown contract review is not seen as necessary or of value.
Typically a Request for Quote is in the form of a FAX and may be a voice telephone call. The Vice-President of Operations reviews each contract prior to acceptance, however if the request is for a standard product the main basis for review is pricing. However, once a contract is approved by the VP of Op follow on orders from the same company for the same product are not reviewed again unless a change in product occurs.
4. Is there a differentiation between
- Standard products
Standard products are those for which there is an existing formula (design).
- Special products (if relevant)?
There are no 'special products' in our business. Not relevant.
5. Are quotations (tender) and contract or order compared before confirming the order?
The Vice-President of Operations compares quotations to orders when appropriate. For the most part orders are for product by product name/number without an extraneous requirements stated by any customer.
6. Are contract reviews including comments of involved organizational units documented?
Where contract reviews are determined to be required, they are documented on the Contract Review Form which is then appropriately filed. Meetings are generally individual interfaces as appropriate to this size of a company.
4.3.3 Amendment to a contract
7. Are procedures for amendments to the contract or the order documented?
Only contract amendments where a product change or other SIGNIFICANT change (such as a significant volume increase or decrease) are documented.
8. Are amendments to the contract discussed with the involved organizational units?
Every 'organizational unit' affected, as determined by the VP of Op, is involved in contract amendments in the same manner as for the original review.
4.3.4 Records
9. Are records of contract reviews being maintained? See Quality System Element 4.16 "Control of quality records".
Records are maintained as detailed in the systems manual and the Controlled Document Matrix.
4.4 Design Control (This Quality System Element is not part of ISO 9002)4.4.1 General
1. Does the quality manual contain regulations for the design control?
The company systems manual specifically details Company X Chemicals design control methodology.
2. Is there a list available specifying on-going design and development projects? (If necessary)
We do not maintain a list of active design projects as there are not enough (numerically) for a need for such a list.
3. Is the current design and development status evident?
Yes - By review of the records associated with the project, the status can be determined.
4.4.2 Design and development planning
4. Are there provisions for the planning of the design and development activity?
Yes - There is a design planning form and system defined which addresses required provisions.
5. Do these provisions contain:
- Responsibilities for each phase
Not for each phase. The VP of Production defines responsibilities, organizes and oversees the entire project.
- Product requirements
These are detailed on the design review form.
- Descriptions of activities
These are detailed on the design review form.
- Including design review/verification/validation
These are detailed on the design review form.
- Personnel requirements
These are detailed on the design review form.
- Resources requirements
These are detailed on the design review form.
- Responsible staff for the implementation?
Implementation is organized and overseen by the VP of Production.6. Is it assured that plans for the development activity are continuously updated as the design evolves?
The VP of Production ensures that design evolution is addressed as appropriate for each individual design project. Company X Chemicals does not have critical designs involving complex development activities.
7. Are qualified personnel assigned to these activities? For example, qualification profile, plan for training requirements, training records (certificates).
Yes - qualified personnel are identified and assigned by the VP of Production. There is no 'qualification profile' as one is not necessary. Training plan is limited to appropriate training for each job.
8. Are adequate resources available to carry out these activities? For example, information systems, software, experimental equipment, test equipment.
Adequate resources are available as determined by the VP of Operations and/or the VP of Production with consideration to the size and complexity of Company X Chemicals operations.
4.4.3 Organization and technical interfaces
9. Are the requirements for design/development activities that are carried out by external groups
- Defined by descriptions and
- Are the requirements reviewed?
External inputs and activities are limited to customer interfaces. These are determined specifically for each design effort. Company X Chemicals has not determined a need for a standard customer interface for every design effort.
10. Are the organizational and technical interfaces between different people which are involved in the design process defined?
Design is carried out principally by the VP of Production with the VP of Operations. There are no defined interfaces. Each area is addressed, including the appropriate people, with consideration to the design needs by the VP of Operations and/or the VP of Production.
11. Is the information documented, distributed to the involved people and regularly reviewed?
Company X Chemicals design system is not complex enough to require 'regular reviews' and such. Appropriate documentation is kept and appropriate people are updated as required by the specific design project. There are 3 points on the Design Process flow chart where reviews are made, however they are only documented to the extent deemed necessary by the VP of Production.
12. Do unambiguous input requirements exist for the development based on contract reviews or similar?
Yes - see the design review form.
13. Are individuals appointed who are responsible for the design input?
This is always the VP of Production.
14. Are the product requirements reviewed for completeness and clarity?
Yes - by the VP of Production.
15. Is it ensured that applicable standards are being complied with?
Yes - by the VP of Production.
16. Is it defined how problems due to ambiguous, conflicting, and incomplete requirements can be resolved?
This is the responsibility of the VP of Production as detailed in the systems manual.
4.4.5 Design output
17. Is it defined in which way design output is documented? For example, in drawings, calculations, specifications, safety analyses, etc.
Yes - as detailed in the systems manual.
18. Does acceptance criteria exist for the design output?
There are defined design outputs (see Design Process flow chart) one of which is Test Procedure which is the acceptance test (criteria determined earlier in design process).
19. Are those design characteristics that are crucial to the safe and proper functioning of the product identified? For example, operating/storage/maintenance/disposal requirements.
Yes - as appropriate. See the Design Review form - Employees Concerns, etc.
4.4.6 Design review
20. Is it defined how the design output shall be reviewed?
Design output is reviewed by the VP of Production as detailed in the systems manual.
21. Is the design output being reviewed and evaluated?
It is - By the VP of Production as appropriate to the design project.
22. Does the design output meet the input requirements?
They do. This is ensured by the VP of Production.
23. Does the review/verification of design output cover, for example:
- Checking clarity and completeness in regards to the requirements
- Undertaking quality inspections/tests
- Performing alternative calculations
- Comparing the new design with similar designs?
It does as appropriate to the design project as determined by the VP of Production.
24. Are verifications done by assigned personnel and are they traceable?
Verification is by the VP of Production. They are documented (and traceable) as appropriate to the design project.
25. Are the single review results being documented?
Design review is seen as a continuous process. The VP of Production is constantly aware of all elements of the design process. The design process is not a complex process with consideration to the product and customer requirements.
26. Are the documents stored in accordance with the requirements?
Yes. They are stored (filed) appropriately with retention defined on the Controlled Documents Matrix.
4.4.7 Design verification/design
27. Is it regulated that at appropriate design stages, design verifications are being performed?
This is satisfied by completion, in stages, of the Design Review form.
28. Are the design verification measures being recorded?
Yes - As part of the Design Review form.
4.4.8 Design verification/design
29. Is it defined under which conditions the design validation
- On the final product or
- Prior to product completion has to be performed?
Design validation criteria is based upon customer requirements and other issues such as similarities to existing products. For example, a slight shift in a raw material added as a per cent by weight, may not require a critical design evaluation. Customer requirements plays the largest part here. Each design effort is different. Timing, including at what stage of the process validation will take place, is project dependent.
30. Do unambiguous requirements exist for the performance of the design validation?
The VP of Production ensures requirements are as unambiguous as appropriate and possible for each design project with consideration of product use intent and customer requirements.
4.4.9 Validation/Design changes
31. Are the procedures and responsibilities for design changes defined?
Yes - They are limited to the Vice-President of Operations who coordinates with the Vice-President of Operations and other personnel as necessary.
32. Are design changes
- Reviewed
- Unambiguously characterized
- Reported to the involved organizational units
- Documented?
Yes - They are by the Vice-President of Operations who coordinates with the design change project.
33. Are design changes approved by authorized personnel before their implementation?
Yes - They are limited to the Vice-President of Operations.
4.5 Document and Data Control4.5.1 General
1. Does the quality manual contain regulations for the control of all documents and data?
The systems manual defines or points to appropriate systems for control of applicable documents and data.
2. Are documents/data of external origin controlled, such as
- Statutory and regulatory requirements
- Standards
- Technical rules
- Drawings/specifications of customers?
Yes - As detailed in the systems manual.
4.5.2 Document/data approval and issue
3. Are responsibilities assigned for the
- Establishment
- Review
- Release
- Identification
- Distribution of
a) System-related - for example, quality manual/quality procedures/work instructions / inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans.
c) Governing - for example, laws, regulation, standards.Yes - In accordance with the systems manual, document control system flow chart and the controlled document matrix.
4. Are lists/tables of valid quality documents/electronic data maintained?
Yes - See the controlled documentation matrix.
5. Are all documents clearly marked?
Documents are marked clearly as appropriate for the individual document.
6. Is it ensured that the current revision status of documents/files is identifiable?
It does for revision sensitive documents as appropriate to a company of this size.
7. Is it ensured that the current revision of
a) System-related - for example, quality manual/quality procedures/work instructions/ inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans
c) Governing - for example, laws, regulations, standards. documents/data are available at the relevant places?Yes. Each person who uses a controlled document is responsible for knowing and understanding how to verify they are using the appropriate version. Each person is also responsible for ensuring they are using the appropriate version.
8. Is a distribution index defined for
a) System-related - for example quality manual/quality procedures/ work instructions /inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans.
c) Governing - for example, laws, regulations, standards. documents/data?Distribution lists are not used. Each document has a point of presence denoted on the controlled document matrix as it's 'Location'. Each person who is responsible for a document (as defined on the controlled document matrix) is responsible for appropriate distribution of the document and notifying affected employees of revisions when they occur.
9. Are procedures established to ensure that obsolete
a) System-related - for example quality manual/quality procedures/ work instructions /inspection instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans.
c) Governing - for example, laws, regulations, standards.Documents/data are removed from all locations of use or are clearly marked as "invalid"?
Yes - the employee responsible for the document is responsible for ensuring the obsolete document is removed from its point of use as defined by the controlled document matrix.
4.5.3 Document and data changes
10. Are responsibilities defined for handling changes regarding
- Reviews
- Releases
- Identifications
- Distributions of
a) System-related - for example, quality manual/quality procedures/inspection instructions/detailed instructions.
b) Order-/product-related - for example, drawings/specifications/recipes/work plans
c) Governing - for example, laws, regulations, standards document/data?The responsibility for handling changes is that responsible employee listed in the controlled document matrix. Each of these elements is addressed.
11. Can changes of
- System-related (for example, quality manual/quality procedures/inspection instructions/detailed instructions).
- Order-/product-related - for example, drawings/specifications/recipes/work plans
- Governing (for example, laws, regulations, standards documents/data)
be reviewed/approved by organizational units different from those who performed the original review/approval?
This is not applicable to Company X Chemicals as everything is in one location and only 15 employees total are involved.
12. Are procedures, responsibilities and the time for storage of the quality documents defined?
The VP of Operations is responsible for storage of records for the period defined in the controlled documents matrix.
4.6 Purchasing4.6.1 General
1. Does the quality manual contain regulations for the product purchasing?
Yes.
2. Are purchasing processes defined regarding
- Evaluation of suppliers ( The supplier is meant to be the supplier, vendor or service provider.)
Evaluation of suppliers is minimal. The products being bought are commercial grade chemicals
- Requisition determination
???
- Ordering activities
Yes.
- Procedures for handling changes?
Yes.
4.6.2 Evaluation of suppliers
3. Are suppliers selected on the basis of defined criteria? For example, first samples, inspections of incoming product, quality audit reports, previous deliveries, certified quality system, recommendations. The selection has to depend on the product type.
Yes, however limited due to the nature of the raw materials used in the product.
4. Are procedures and responsibilities defined concerning the selection of suppliers for:
a) Products
Yes
b) Involved production facilities
NA
c) Services?
Yes5. Does a product/performance related list/data base of qualified suppliers exist?
A list exists and is maintained by the VP of Operations.
6. Are procedures and responsibilities established for:
- Accepting new suppliers on the list
- Establishing and maintaining quality records of acceptable suppliers
- Deleting suppliers from the list? (For example, based on the results of the ongoing supplier assessment)
4.6.3 Purchasing data
7. Are procedures and responsibilities established for
- The definition of requirements
- The review/release of purchasing documents for
a) Products to be purchased
b) Production facilities to be involved
c) Services to be provided?8. Do the purchasing documents contain clear descriptions of
- Products
- Involved production facilities
- Services?
For example, type class, grade, product requirements, quality characteristics, standards, quality evidence, identification/marking, packaging requirements, specifications, drawings process requirements, inspection instructions.9. Where appropriate, do the purchasing documents contain information about applicable standards?
4.6.4 Verification of purchased product
10. Are procedures and responsibilities defined for the supplier's verification of the purchased product at the supplier's premises?
11. Are there procedures for developing a contract in case the customer wants to verify the purchased product at the supplier's premises?
4.7 Control of Customer-Supplied Product1. Does the quality manual contain regulations for the responsibilities for
- Verification
- Storage
- Maintenance of customer-supplied product?
In regards to: product acceptance, receiving inspection, marking, handling, storage, servicing, maintenance.
2. Are procedures for control of
- Lost
- Damaged/unsuitable
- Defective products established?
3. Is it defined that any such product which is
- Lost
- Damaged
- Otherwise unsuitable for use is recorded and reported to the customer?
4.8 Product Identification and Traceability1. Does the quality manual contain regulations for the responsibilities of the identification/ traceability of the
- Planning
- Realization?
2. Are all phases of production taken into consideration
- At receipt
- During production
- During storage, packaging, transportation, and delivery?
3. Are the regulations for the identification maintained?
4. Is it ensured that mix-ups are precluded?
5. Is it ensured that the documented procedures for traceability are followed?
6. Is it ensured that the product marking/identification is recorded, to the extent that traceability is specified?
4.9 Process Control1. Does the quality manual contain regulations for the
- Production
- Installation
- Maintenance processes, which directly affect quality?
2. Do documented procedures exist defining the manner of
- Production
- Installation
- Maintenance, and are the procedures, if necessary, supplemented by work procedures?
3. Is the cooperation defined between the
- Production
- Installation
- Servicing planning and the inspection planning?
4. Is it ensured that the appropriate regulations and standards are taken into consideration while preparing manufacturing documents?
- The instructions include, for example, detailed descriptions of production and production equipment.
5. Are production documents available at the work place? Are they applied [used]?
6. Are the respective work/inspection instructions available at the work place?
7. Is it ensured that the performing of working and inspection steps is being documented?< P> 8. Is a suitable working environment ensured by the legislator/supplier according to the requirements of the process? - For example, cleanliness, lighting conditions, temperature, noise, work clothing, work safety.
9. Is quality control performed, based on suitable product and process parameters?
10. Is test and measuring equipment used for process monitoring and control controlled? - See Quality System Element 4.11 "Control on inspection, measuring and test equipment".
11. Are production facilities maintained in order to ensure the process safety and is this documented?
12. In case of special processes, do the following take place:
- Qualification/study review of the process
- Definition of process parameters
- Monitoring of compliance with these parameters
- Qualification of personnel? Is this documented? - See also Quality System Element 4.18 "Training".
4.10 Inspection and Testing4.10.1 General
1. Does the quality manual contain regulations for the
- Preparation - Review/release of plans/instructions for the
- In-process inspection
- Final inspection
- Inspection and test records?
2. Is it ensured that all necessary primary documents are being considered for the inspection planning? - This includes, among other things, statutory and regulatory requirements, technical regulations, standards, specifications.
4.10.2 Receiving inspection and testing
3. Do written instructions exist for performing the receiving inspections, and are the responsibilities defined? This is in regards to
- Incoming product notification
- Conformity of product with purchased quantity/quality
- Transportation damage
- Identification of test status
- Control of nonconforming products
4. Do the inspection documents contain the necessary requirements? - Such as quality characteristics, inspection criteria, inspection method, inspection procedures, inspection sequence, inspection location, inspection time/inspection equipment, acceptance/rejection criteria, inspection records.
5. Are results of previous inspections taken into consideration when planning the inspection scope?
6. Are inspection documents available at the work place?
7. Is it insured that inspections are conducted and documented according to the inspection requirements?
8. Is there evidence that the inspection results are being recorded and retained?
9. Can inspected products be distinguished from not yet inspected products? - See Quality System Element 4.12 "Inspection and test status".
10. Are nonconforming products treated specially? - See Quality Element 4.13 "Control of nonconforming product".
11. Do regulations exist dealing with pre-releasing incoming product for urgent production?
4.10.3 In-process inspection and testing
12. Are procedures and responsibilities defined for the performance of in process inspection?
13. Do the inspection documents contain the necessary requirements? - Such as characteristics, inspection criteria, inspection method, inspection procedures, inspection sequence, inspection location, inspection time/inspection equipment, acceptance/rejection criteria, inspection records.
14. Are inspection documents available at the work place?
15. Is it ensured that inspections are conducted and documented according to the inspection requirements?
16. Is there evidence that the inspection results are being recorded and retained?
17. Is it insured that inspected products can be distinguished form not yet inspected ones?
18. Are nonconforming products treated specially?
4.10.4 Final inspection and testing
19. Are documented procedures and responsibilities defined for the performance of final inspections?
20. Do the inspection documents contain the necessary requirements? - Such as characteristics, inspection criteria, inspection method, inspection procedures, inspection sequence, inspection location, inspection time/inspection equipment, acceptance/rejection criteria, inspection records.
21. Are inspection documents available at the work place?
22. Are instructions, as applicable, available for the handling of samples regarding
- Sample selection
- Identification
- Forwarding to the laboratory
- Registration?
23. Is it ensured that inspections are conducted according to the inspection requirements?
24. Are inspection personnel properly trained?
25. Is the final inspection, if necessary, carried out by independent personnel or does this personnel supervise or audit the self inspection?
26. Is there evidence that the inspection results are being recorded and retained?
27. Is it insured that inspected products can be distinguished from not yet inspected products? - See Quality System element 4.12 "Inspection and test status".
28. Are nonconforming products treated specially? - See Quality System element 4.13 "Control of nonconforming product".
29. Is it ensured that only those products are dispatched for which it could be proved that all specified requirements have been fulfilled according to the quality plan, and which have been released?
4.10.5 Inspection and test records
30. Do the inspection and test records show clearly whether the product has passed or failed the inspection according to the defined criteria?
31. Is the inspection authority responsible for the product release identified in the inspection records?
32. Is it defined, if agreed upon,
- Which inspection/test evidence is given to the customer, and
- Who is responsible for compiling these?
4.11 Control of Inspection, Measuring, and Test Equipment4.11.1 General
1. Does the quality manual contain regulations for the control of inspection, measuring, and test equipment? - Reference: ISO 10012 "Quality Assurance Requirements for Measuring Equipment".
2. Is the test software and test hardware, used for the quality inspection and testing, inspected and are release criteria defined?
3. Is it ensured that the technical data for the inspection, measuring and test equipment /inspection methods is made available to the customer, if agreed upon in the contract?
4. Are the procedures binding and are they being followed accordingly?
4.11.2 Control procedure
5. Do the inspection records contain specifications for
- Measurements to be conducted
- Required accuracy/measurement uncertainty
- Proved capability of the test equipment?
6. Is it ensured that all inspection equipment is registered, e.g. on index cards or in an inspection equipment database?
7. Do the instructions cover information regarding:
- Marking
- Identification number
- Measurement range/accuracy
- Verification interval
- Inspection criteria, reference to inspection/calibration instruction relatively
- Inspection result
- Date of control?
8. In the case of calibration, is the entire calibration process planned considering the following requirements? For example regarding
- Reference to national or international standards
- Appropriate environmental conditions
- Proof of calibrations status
- Appropriate calibration intervals
- Use of third parties, if applicable
- Documentation
- Marking with control date?
9. Is all inspection equipment affecting the product quality calibrated or adjusted regularly?
10. Are the control procedures defined for inspection equipment that does not have a relation to national standards? - For example, reproducibility and repeatability studies, comparison studies, etc.
11. Are regulations for the maintenance of calibration records defined?
12. Are procedures defined in case that quality inspections were conducted with inspection equipment that is found to be out of specification?
13. Is it ensured that inspection equipment provided by suppliers and third parties is being controlled?
14. Are written instructions for the control of inspection, measuring and test equipment available at the work place?
4.12 Inspection and Test Status1. Does the quality manual contain regulations for the identification of the inspection and test status of product?
2. Are procedures and responsibilities defined, among other things, for:
- Identification of inspection and test status throughout production, installation and servicing
- Product release
- Assignment of personnel and inspection identification
- Records
- Concession for products on hold?
3. Is there any evidence which authority is responsible for the release of product?
4. Is it ensured that only inspected and released products are being dispatched, used or installed?
5. Can the inspection status be identified in all phases:
- Receiving
- Incoming product storage
- During production
- Intermediate storage
- Final test/inspection
- Shipment/final storage
- Maintenance/servicing?
6. Are written instructions for the identification of the inspection and test status well known and established?
4.13 Control of Nonconforming Product4.13.1 General
1. Does the quality manual contain regulations for the control of nonconforming products?
4.13.2 Review and disposition of nonconforming product
2. Is it specified that nonconforming products/product units have to be identified by suitable methods (hold labels, etc)?
3. Is it specified how nonconforming products have to be recorded, stored, and reported?
4. Are responsibilities defined regarding review, decision, and documentation of:
- Rework
- Concession
- Coordination with customer
- Alternative applications
- Regrade
- Recall
- Scrapping?
5. Do procedures and responsibilities exist for reinspection and is the result being documented?
6. Do regulations exist concerning required approval by the customer for intended use or repair of nonconforming product and are they followed?
7. Are accepted-as-is products or repairs recorded in order to document the actual condition?
4.14 Corrective and Preventive Action4.14.1 General
1. Does the quality manual contain regulations for corrective and preventive action?
4.14.2 Corrective Action
2. Is it ensured that:
- Necessary corrective action to eliminate the causes of nonconformities is defined
- Corrective actions are implemented and controlled effectively?
4.14.3 Preventive Action
3. Is it ensured that
- Preventive actions are implemented and their effectiveness is controlled
- Information from preventive action is being used for the evaluation of the quality system?
- This includes information on work operations and processes, concessions, audits, service reports, customer complaints.
4. In reference to corrective action:
- Are customer complaints and reports of nonconforming products being analyzed?
5. Does corrective and preventive action also affect suppliers?
4.15 Handling, Storage, Packaging, Preservation and Delivery4.15.1 General
1. Does the quality manual contain regulations for handling, storage, packaging, preservation and delivery?
2. Do these regulations contain definitions for:
- Planning and control of purchased, in-process and finished products (storage instructions)
- Identification and use of appropriate palettes, containers, moving equipment and vehicles
- Means and methods of storage and transportation until setup and use
- Consideration of the customer's requirements
- Preservation?
4.15.2 Handling
3. Is it ensured that the supplier provides methods of handling product that prevent damage or deterioration?
4.15.3 Storage
4. Are appropriate storage areas or stock rooms designated to prevent product damage or deterioration during
- Receipt of product
- Incoming product storage
- Final storage?
5. Is it ensured that storage procedures define:
- Authorization for receipt to and dispatch from such areas
- Control of the product condition
- Monitoring of products with limited shelf-life
- Storage of rejected products
- Responsibilities to inform and report
- Designation of storage areas?
4.15.4 Packaging
6. Is it ensured that packing, packaging and marking processes are observed?
7. Are procedures and responsibilities defined for:
- Clear identification of packed product
- Transport instructions
- Warnings/delivery methods
- Operation manual
- Inspection of packaging material?
4.15.5 Preservation
8. Are appropriate methods for preservation and segregation of product applied?
4.15.6 Delivery
9. Is it ensured that the quality is maintained until delivery and, where contractually specified, final destination?
10. Is it ensured that only approved products are delivered?
4.16 Control of Quality Records1. Does the quality manual contain regulations on the control of quality records?
2. Are regulations defined for:
- Establishment
- Distribution
- Unambiguous identification
- Easy access
- Prevention of damage
- Prevention of loss
- Secure and clear filing
- Systematic indexing and reference to units and activities
- Archiving (duration and place)
- Guaranty of legibility
- Collection of the suppliers quality records?
3. Is it ensured that the product's conformity to specified requirements and the effective operation of the quality system can be demonstrated by the quality records?
Quality records are, for example: records of quality system evaluation and of development activities; development records; contract records; assessment of suppliers, inspection reports; inspection equipment records; statistics of nonconformities; records of corrective actions; audit records; statistical analyses; documents of customer complaint evaluations; proof of training.4. Are suitable procedures established and responsibilities assigned for quality records stored on electronic media? Are they effectively implemented?
5. If agreed upon in contract, are the quality records made available to the customer?
4.17 Internal Quality Audits1. Does the quality manual contain regulations for the planning and implementing of internal quality audits?
2. Are regulations included for:
- Planning of audits (audit plan)
- Review of all quality system elements at periodic intervals
- Advance notice to the areas to be audited
- Document action of the audit results
- Bringing audit results to the attention of the areas and the personnel
- Information of the management
- Implementation of corrective actions
- Selection and training of auditors
- Use of auditors who have no responsibility for the area being audited
- Verifying the effectiveness of the results by follow-up audits?
3. Do personnel responsible for the area take corrective action?
4. Are extraordinary audits carried out, if necessary?
4.18 Training1. Does the quality manual contain regulation for the identification of training needs for all personnel performing activities affecting quality?
2. Are regulations defined for personnel training:
- Education (organizational interrelations; job-related)
- Supplementary training (e.g. new working and test methods)
- Special qualifications/skills
- Quality system training?
3. Is the requirement profile defined for:
- Management
- Engineering personnel/administrative personnel? ( For example, in job descriptions).
4. Are training needs identified regularly?
5. Are work specific requirements considered during the planning of training needs, for example, for:
- Quality inspections
- New work methods
- New inspection equipment
- New work resources and procedures?
6. Are records and proofs of actual training and qualifications prepared and retained?
7. Is it ensured that qualifications necessary for the job are maintained by means of, for example:
- Repetitions
- Developments
- Reevaluations?
4.19 Servicing1. Does the quality manual contain regulations for servicing, if agreed upon in the contract?
2. Is it ensured that the customer is being informed by suitable documents, such as:
- Installation/assembly instructions
- Warnings
- Operation manuals
- Maintenance instructions
- Spare parts list?
3. Is it ensured that the maintenance personnel/servicing personnel is sufficiently equipped with resources, such as:
- Tools
- Test equipment
- Product information
- Service instructions?
4. Do spare parts lists exist, if necessary, and is there a controlled spare parts stock?
5. Are customer complaints evaluated and forwarded to responsible units for handling?
6. Is market feedback being evaluated and is this considered for the development/manufacturing of new products?
4.20 Statistical Techniques1. Does the quality manual contain regulations for the realization and control of the application of required statistical techniques?
- Design control: Risk analyses, FMEA, statistical tests and analyses, etc.
- Process control: X-R charts, capability studies, etc.
- Inspections: Plan for sampling, for example during receiving, in-process, and final inspection.
- Inspection equipment: Capability studies, etc.
2. Does the customer require the application of statistical techniques?
3. Is the need for the application of statistical techniques identified?
4. Are statistical techniques used for proof of capability and acceptance decisions regarding:
- Processes
- Measurement equipment
- Machinery?
5. Are statistically evaluated quality data/records being used for the identification/scheduling of corrective action?
This page last reviewed or edited: Wed, 2018-11-21 11:51 AM EST USA (Coordinated Universal Time [ZULU] -4 hours)