Common nonconformities in the audit of the hottest

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Common nonconformities in quality management system audit

(5) the quality manual cannot completely reflect the nature and characteristics of the organization

(6) the control and operation methods specified in the procedure documents are inconsistent with the current application

(7) the procedure documents are inconsistent with the quality manual

(8) the issuance, modification and management of the quality manual are relatively chaotic, and the latest effective version cannot be guaranteed to be used on site.

2. Document control (standard clause 4.2.3)

(1) the procedure does not involve the control of invalid documents

(2) external documents and outgoing documents are not listed in the scope of control

(3) electronic media and other forms of documents are not under control

(4) there is no approver for the issued document

(5) the revision status of the document cannot be recognized

(6) invalid documents not marked and saved

(7) the external documents have not gone through the identification procedures

(8) documents were not reviewed regularly

(9) the distribution of documents is not controlled, and they are copied casually

(10) poor custody, unable to produce documents quickly

(11) the document change record is not or inappropriate

(12) documents are copied or changed by unauthorized persons

(13) the document used on site is not a valid version, or the valid version coexists with the invalid version

3. Record control (standard clause 4.2.4)

(1) the supplier's quality records are not included in the control scope

(2) there is no quality record control method in the form of electronic media

(3) the storage environment of quality records does not meet the requirements

(4) the quality records do not specify the methods of identification, storage, protection, retention period and disposal

(5) the quality record is incomplete, and there is no signature of the recorder on the quality record

II. Management responsibilities (standard clause: 5)

1. Management commitment (standard Clause 5.1)

(1) top management does not know what evidence should be provided for management commitment

(2) the members of the organization have their own understanding of the quality policy and quality objectives

(3) insufficient resource allocation, poor quality of inspectors, and untrained internal auditors

2. Focus on customers (standard clause 5.2)

(1) unable to take out documents to confirm that customers' requirements have been determined

3. Quality policy (standard clause 5.3)

(1) the quality policy is empty, does not reflect the characteristics of the enterprise, and the relationship with quality objectives is not clear

(2) subordinate personnel do not know the quality policy

(3) there is no evidence of review of the quality policy

(4) some departments have also formulated quality policies

4. Quality objectives (standard clause 5.4.1)

(1) the content of quality objectives is incomplete and does not include the content required by product requirements

(2) the quality objectives are inconsistent with the framework given by the quality policy

(3) quality objectives are not measurable

(4) the achievement of quality objectives cannot provide evidence

5. Quality management system planning (standard clause 5.4.2)

(1) there is no detailed description of the tailoring allowed in the quality management system

(2) during the change, the integrity of the quality management system cannot be maintained

6. Responsibility and authority (standard clause 5.5.1)

(1) the interface relationship between personnel is not clear, and there is often wrangling when encountering specific problems

(2) it is not clear that the approval authority decides or deals with certain things (such as how to dispose of nonconforming products, etc.)

(3) the organization chart cannot clearly reflect the relationship between each other, rank relationship, etc

7. The management representative (standard clause 5.5.2)

(1) did not clarify the responsibilities of the management representative in the form of documents

(2) the responsibilities of the management representative are incomplete

8. Internal communication (standard clause 5.5.3)

(1) the purpose of communication is not clear

(2) the tool of communication is not clear

9. Management review (standard clause 5.6)

(1) management review records are not saved

(2) the content of management review does not meet the requirements

(3) the management review is not performed by the top management

III. resource management (standard clause 6)

1. Resource provision (standard clause 6.1)

(1) the way of resource provision is not clear

(2) insufficient resource allocation

2. Human resources (standard Clause 6.2)

(1) capacity needs are not determined

(2) records of education, training, skills and experience are not kept

(3) no assessment after training

(4) no training on quality awareness

(5) inspectors, internal auditors and metrological personnel in China's construction machinery enterprises have not obtained training qualifications in products, skills and innovative talents

(6) replace the work license with educational background

(7) training instead of job qualification recognition

3. Infrastructure (standard clause 6.3)

(1) inadequate facilities and equipment

(2) equipment maintenance records are not kept as required

4. Working environment (standard clause 6.4)

(1) the working environment does not meet the requirements

IV. product realization (standard clause: 7)

1. Planning of product realization (standard clause 7.1)

(1) no quality plan is prepared for specific new products, projects, processes and contracts

(2) when establishing and implementing the quality plan, the allocation of necessary personnel and resources was ignored

2. Customer related processes (standard clause 7.2)

(1) product requirements are unclear and not documented

(2) there are no product requirements, and there is a deviation in the understanding of the content of product requirements review for the production but for the laboratory machine industry

(3) the contract is not checked according to the tender

(4) the review results and follow-up measures are not recorded or the records are vague

(5) sporadic and oral customer requirements (in the form of oral orders and contracts) were not reviewed

(6) it is found that the organization has no ability to perform the contract at the time of delivery

(7) when the product requirements are changed, the relevant personnel are not notified in time

(8) insufficient communication with customers during the processing of contracts and orders

(9) there is no record of handling customer complaints

3. Design and development (standard clause 7.3)

(1) the interfaces of different groups involved in the design (between design departments, between design departments and other departments) are not specified

(2) the design input is not documented and not reviewed. Applicable decrees and laws are not included in the design input

In May, 2013, the author visited the Pittsburgh technology center of Alcoa with the Henan delegation to the United States.

(3) the design and development plan (the result of planning) was not prepared, and the plan was not timely modified with the progress of the design

(4) the responsibilities and stages of each design are not clear

(5) the design output data is incomplete, does not meet the requirements of the input, does not include or quote the product acceptance criteria in the output, and important product characteristics are not specified

(6) the design output document was not approved before distribution

(7) the design has not been reviewed/verified/confirmed, or it is still put into production if the review is unqualified

(8) the tracking measures after review, verification and confirmation were not recorded

(9) design changes were not identified and documented

(10) the change approver has no authorization basis

4. Procurement (standard clause 7.4)

(1) the evaluation results of suppliers, especially the tracking measures, are not recorded. The supplier on the purchase order is an unapproved supplier

(2) the purchase document and purchase order are not approved before being issued

(3) for suppliers designated by customers, the organization will not review or verify their products

(4) there is no criterion for selecting and evaluating suppliers. J

(5) the content of the procurement document does not clearly indicate the requirements of the ordered products (such as product quality requirements, acceptance requirements, etc.)

(6) for suppliers with poor quality, no corrective measures have been taken and tracked for verification

(7) the approved suppliers were not reviewed within the specified time

(8) there are no management regulations for the modification of the purchase order

(9) the verification method of purchased products is not clear, or although it is clear, it is not implemented

(10) when the organization or customer implemented the verification at the supplier's site, the verification arrangement and product release method were not specified in the procurement documents

(11) no review and other control activities were carried out on service suppliers (such as measuring instrument verification suppliers, entrusted inspection authorities, transportation companies, etc.)

5. Control of production and service provision (standard clause 7.5.1)

(1) incomplete information to control the production and service process, lack of operation instructions or operation instructions are not detailed and correct enough to affect product quality

(2) the operation of operators does not comply with the operation instructions

(3) the equipment is not under normal maintenance

(4) the working environment has not been effectively controlled

(5) there are no monitoring measures for special processes, key processes and quality control points

(6) the operator has not been trained or has no training record

(7) there is no planned control in the production process (such as daily control of input, in-process and output)

(8) invalid drawings and specifications are still in use

(9) the received raw materials have no specified identification or inspection status

(10) no conditions for product release are specified

(11) products with incorrect models were shipped

(12) truck transportation companies or ship transportation companies have not been reviewed

(13) no corrective measures were taken for the loss of goods during transportation

(14) the goods are not correctly marked and the accompanying documents are incomplete

(15) the management measures after delivery (after-sales service) are not specified, or they are specified but not implemented, or have no effect

(16) the after-sales service specified in the contract has not been implemented or has not been recorded after implementation

6. Confirmation of production and service provision process (standard clause 7.5.2)

(1) no confirmation of special process

(2) the confirmation process and method are not specified

(3) necessary reconfirmation will be carried out after the process change

7. Identification and traceability (standard clause 7.5.3)

(1) products in production do not have appropriate identification to prove their identity (process card, work order, route card, etc.). Similar objects are difficult to distinguish

(2) in the case of traceability, the product identification is not unique and cannot be traced

(3) traceability cannot be achieved due to fracture during traceability implementation

(4) the product identification system is too simple or too complex to identify products in a suitable way and is not operable

(5) the product logo disappears in use and is not added as required

(6) the marks are not transferred to each part as required during product segmentation and sub packaging

(7) when the product has an expiration date limit, the product is not marked with an expiration date. Type a fixture 1 is generally applicable to pipe diameter φ Plastic pipes below 630

(8) the package identification does not meet the requirements

(9) nonconforming products are not marked

(10) signs disappear and are altered from time to time

(11) the inspection state has changed, and its identification has not changed

(11) the parts, seals, signatures and records specified in the inspection status are incomplete

(12) the on-site products have no inspection status identification or the identification is wrong

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