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The company needs to renew its manufacturing license. Are there any colleagues who have recently gone through this process? Please share the problems you encountered so that we can learn from them. Or what needs to be noted when renewing the certificate, especially since many standards have changed. Thank you
First, go through the system documents; the technical documents are likely to require the most modifications. Establish records for issuance and retrieval
There are a few points to consider. In addition to what was mentioned by the colleague upstairs, it is first necessary to check whether the scope of the license includes any experience in container manufacturing at various levels, especially since products of levels A1, A2, and A3 do not cover each other; There are also outsourcing agreements and qualified supplier evaluations ; Are internal audits and management reviews conducted once every 12 months or annually as required? ; Record of Handling Non-conforming Items ; Procedures for the acceptance of materials upon arrival, the division of the storage area into three zones, labeling of materials and transfer of labels, acceptance of welding materials upon arrival, the division of the primary storage area into three zones, monitoring and recording of temperature and humidity, identification of any expired welding materials, as well as records related to the retrieval, drying, distribution, and recycling of welding materials ; Also, it is necessary to divide into four groups as suggested by the review team: Resources, Quality Assurance System Operation, Product Quality, and Logistics, and assign a leader for each group.
Thank you to the person above; it would be great to have actual examples available, so as to facilitate self-checking or to address the corrective actions suggested at the final meeting of the inspection team.
I need this material too to study it! ! ! ! !
I just participated in an assessment for the renewal of A1, A2, and A3 level licenses; it’s these issues that are particularly important, receive attention, and are recorded in the minutes. Of course, there is also the question of whether records are kept and filled out for the manufacturing process flow cards ; Non-destructive testing techniques and film evaluation will also receive attention. :lol
Are there any essential standards and regulations for the renewal process? Which regulations are essential?
Materials to be prepared by the entity applying for certificate renewal: 1. The materials to be provided to each reviewer are generally: a) Quality manual; b) Program files or management systems ; c) Work instruction manual ; d) Record table summary and sample table ; e) Prepare manufacturing inspection process documents. 2. The documents generally required to be provided to the resource conditions reviewers are: a) Business license (original), organization code certificate (original), various qualification certificates (originals), non-destructive testing personnel certificates (originals), welder qualification certificates (originals) ; b) List of employees of the unit, as well as graduation certificates, professional title certificates, employment contracts, and information regarding salaries and insurance for various technical personnel ; c) Floor plan of the production site, land use certificate (original), property ownership certificate (original), lease agreement (original), etc ; d) Equipment inventory and records, inspection instrument inventory, list of tooling and molds. 3. The documents to be provided to the quality system auditor generally include: a) a list of current regulations and standards along with records of their distribution; b) records of the distribution and retrieval of management system documents; c) records of internal audits and management reviews; d) records of corrective and preventive actions ; e) Quality improvement implementation records ; f) Contract review witness materials ; g) Evidence of qualified supplier evaluation ; h) Subcontractor qualification certificate and evaluation records ; i) Records of personnel training and assessment, etc ; j) Welder’s file ; k) Instrumentation and equipment, calibration plans, calibration records, etc ; l) General process documents, general process cards ; m) Welding procedure specifications and welding procedure qualification documents ; n) Material quality certificates, materials acceptance witness documents and re-inspection reports, material storage and distribution records. o) Product quality feedback records ; p) Inspection and monitoring liaison forms, inspection and monitoring opinions, and documentation of handling results. 4. The materials to be provided to the product reviewers generally include: a) product production records and product quality files; b) product drawings, as well as calculations regarding strength and safety valve capacity ; c) Procedures for design changes and joint approval records ; d) Special processes related to the products sampled for inspection ; e) Welding processes related to the products sampled ; f) Welding quality inspection record ; g) Weld repair records and approval documentation ; h) Welder qualification, witness records showing consistency with the project and products under inspection ; i) Non-destructive testing processes related to the products sampled ; j) Non-destructive testing authorization letter ; k) Non-destructive testing records ; l) Non-destructive testing report ; m) Radiographic inspection films related to the product under inspection n) Qualification certificates of the non-destructive testing personnel involved with the product under inspection o) Heat treatment processes related to the product under inspection p) Records of automatic control during heat treatment q) Heat treatment reports r) Welding test specimens and reports on their mechanical properties s) Records of quality inspections at various stages of production t) Documentation relating to the handling of defective items associated with the product under inspection ; u) Hydrostatic test record ; v) Airtightness test record (applicable only to vapor-phase organic heat carrier boilers) ; w) Quality certificate and compliance certificate for the products leaving the factory.