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1. Reasons for disqualification: 1. The technical personnel of the project team (technical department) are not careful when preparing the work instructions;2. The document reviewers did not carefully review and found that the special characteristics were not identified.
2. Rectification measures: 1. Change the work instructions of a product and identify the special characteristics on the document2. Check all relevant documents such as drawings, FMEA, control plans, work instructions and other documents to see whether the special characteristics are identified and whether the identification is consistent3. Modify the documents that do not identify the special characteristics as required. 4. Attach evidence of rectification.
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There are no spare parts requirements for this device itselfThere are still requirements, but no spare parts?
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Just rectify it according to the requirements!
The certification company still conducts its own internal audit!
Or the customer !!
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The "Catalogue of Qualified Merchants" is the information embodiment of all key components in the CCC report.
Manufacturer information, model number, etc. must be exactly the same.
You should also be looking for **. Just let them give them a template.
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First: What are the provisions of CNCA-07C-031:2007?
Is there a conflict with it?Correction is all about changing the file back;Corrective action is to prevent the recurrence of the non-conformity, such as checking for defects in other documents, and if so, to make changes.
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If the standard is incorrect, the corresponding program document should be modified, the implementation should be reissued, and the corresponding training should be conducted.
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1. Immediately complete the product quality files, including quality records, repair records, customer complaint content, on-site bad treatment records, etc.
2. Set up a document control office and set up a special person to be responsible for the collection and management of quality copywriting
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1. Establish and improve quality files, including all kinds of quality documents, quality records, etc.
2. Set up a special person to be responsible for the collection and management of quality files.
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aiandy2008 says it so well. Don't trust anyone who can handle a CQC factory auditor. And even if it's done all at once.
What about later?Do you have to get it done every time?And the problem of documentation.
I think it's all minor issues. It's better to change it. You don't have to write too complicated.
so that it will be difficult to implement it in the future.
The quality file mainly contains these large parts.
1. For the products produced by our company, the quality department should establish quality files and instruct a special person to be responsible for filing and keeping.
2. The content of the product quality file: product overview and characteristics (product name, specification, approval number and date, brief process flow, main technical characteristics, process prescription, etc.), 3. The scope of quality file filing and storage period.
4. Quality inspection, original records and reports are classified according to different dosage forms of raw materials, packaging materials and finished products. Bound into a book in batches in ** order every month, archived and kept, and kept for one year after the expiration date. The batch records of finished product production are sorted out in batches, archived and kept, and kept until one year after the expiration date.
5. Quality analysis data. The relevant content of the company's quality analysis (participants, quality analysis, solutions to existing problems and analysis of the results of the implementation of the previous meeting, etc.) should be printed into a document, sent to the relevant departments for implementation, and archived and kept for a period of three years.
6. The sample observation record should be provided by the sample observation room of the quality department. The annual summary should be printed into a document, archived for safekeeping, and the storage period is six years, and the original is put into the "product quality portfolio" of the product for permanent preservation.
7. National, provincial and municipal product quality spot check reports, the original of which is put into the "Product Quality Portfolio" for permanent preservation.
8. Quality accident investigation and handling report.
9. User visits, letters and quality complaint handling materials. The content should be registered by the quality department, bound into a book every year, and archived for 5 years. The original is placed in the "Product Quality Portfolio" for permanent preservation.
10. Product quality appraisal summary report information.
11. The product quality file is exclusively for the use of the quality department, and shall not be borrowed, copied or reprinted without the approval of the general manager.
12. The quality files that exceed the storage period shall be identified in detail by the relevant departments, and the personnel responsible for keeping the archives shall write a list of destruction reports, and after the approval of the chief engineer, the relevant personnel shall be assigned to supervise the destruction on site and make a record.
You can refer to the practices of others. Rectify according to the actual situation of your own enterprise.
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Improve the quality inspection of certified products, record standards, reports, documents, etc.
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The reason is that you write it yourself in combination with the actual situation, don't be too fake, and remember to continue to follow up on corrective measures.
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It must be written truthfully, these are the problems of your own factory, and others know so.
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Your situation is in violation of Article 8 of the Quality Assurance Capability Requirements, and internal quality audit complaints to factories, especially complaints that products do not meet standard requirements, should be kept records and should be used as information input for internal quality audits.
Fill in the correction brief below the "Factory Inspection Non-Conformance Report" Reason: Due to *** reasons (the reason should be written as reasonably as possible), the project was not returned to the "Woman's Street Project No. 1 transformer cable damage; Machine Tool Group Engineering Shilin Electrical Damage" and other information are included in the analysis of quality satisfaction.
2.Re-fill in the record and include the information in the analysis of quality satisfaction. Re-audit. And attach *** records (write the name of your record, look at it yourself and attach the relevant records to the auditor and mail).
Note: Make multiple copies of the blank "Factory Inspection Non-Conformance Report", and fill it in again if it is not suitable.
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Correction: Re-write a quality satisfaction analysis report, in addition to the customer's satisfaction, add (in the project return visit, "Damage to the No. 1 transformer cable of the Women's Street Project; Machine Tool Group Engineering Shilin Electrical Damage" and other information) these contents, and finally make a summary!
Cause analysis: due to the unfamiliarity of the project return visitors with the definition of project quality;
Attached information: quality satisfaction analysis report, training records!
I wonder if I understand it?
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What are the specific documents for rectification according to the rectification items proposed in the audit?
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