Beruflich Dokumente
Kultur Dokumente
Re-evaluation
2. Supplier typology:
Typology
Direct to factory Through third party
Details
Name
Details
Quality System Purchasing Manufacturing Subcontracted Manufacturing Quality Management
Final Scoring
B B C N/AP C
Graphic Analysis
Conclusion:
Version: 001
Page 1 of 35
Checkpoint
Introduction
Does the Factory have a fully documented Quality System appropriate to its activities and to the nature of its products and backed by Senior Management? At the manufacturing level, does the system encompass the organizational structure, responsibilities, available resources, procedures and processes involved in Quality Management. Is the organizational structure clearly defined, in order to understand the organization and functioning of the Factory. Does the Factory analyze irregularities and take corrective action as well as ensuring continuous improvement and adequate monitoring.
Score
1.1.2
1.1.3
1.1.4
1.2 1.2.1
Staff
Do the personnel supervising or performing the manufacture or control of cosmetics have the education, training and/or experience to perform the assigned functions. Are the training needs of all personnel at all levels within the Factory identified and the corresponding training plan in place and operational. Is provision made for staff to cover absentees. Do employees receive education in cosmetics GMP Are there instructions for appropriate clothing for external workers (e.g. electricians) and visitors ? Do fixed, written instructions regulate the hygiene? (washing and disinfecting hands)
2009 Annual Training Records: Training records only have the training title, no included the content and personnel involved.
1.2.2
1.2.3 1.2.4
B B B
1.2.5
1.2.6
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Buildings
Are the buildings used in the manufacture or storage of cosmetics of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation and proper cleaning and maintenance.
The garbage was burning in the surrounding area of the building during audit. The waste treatment is not according to operating instructions required.
Buildings (Contd)
Are floors, walls and ceilings constructed of smooth, easily cleanable surfaces and kept clean and in good repair. Are fixtures, ducts and pipes installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment or finished products in bulk. Is the lighting and ventilation sufficient for the intended operation and comfort of personnel. Is the water supply, washing and toilet facilities, floor drainage and sewage system adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness. Are the different manufacturing and storage areas designed to avoid unnecessary movement and cross flows. Are there any hygiene zones and sluices ?
1.3.3
1.3.4
A C
1 Toilet sink was not equipped with Dryers and papers. 2) Toilet (male) opened windows and screens.
1.3.5
1.3.6
B B
Apparatus
Is equipment and utensils used in the processing, holding, transferring and filling of appropriate design, material and workmanship to prevent corrosion, buildup of material or adulteration with lubricants, dirt or sanitizing agents. Are utensils, transfer pipe and cosmetic contact surfaces of equipment well maintained and clean and sanitized at appropriate intervals. Are all measuring instruments used in manufacturing and inspection appropriate, accurate and reliable.
1.4.2
There is no clear requirement regarding how to handle such kind of unexpected broken with glass bottle
1.4.3
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Packaging Workshop and filling workshop: The daily cleaning & sterilization and maintenance record for machine and facility was not available from October to December .
1.4.5
Apparatus (Contd)
Are cleaned and sanitized portable equipment and utensils stored and located, and cosmetic contact surfaces of equipment covered, in a manner that protects them from splash, dust or other contamination.
B B B C
1 Emulsification reaction workshop : The emergency indicator made by glass was found broken . The broken was not cleared out of the production area.
1.5.2
1.5.3 1.5.4
1.5.4.1
B B
1.5.4.2
1.5.4.3
B B
1.5.4.4
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The activities to be conducted prior to beginning any manufacturing operation, for example: Line clearance. The product recall measures. The measures to be taken and procedures to be followed as regards the conformity of packaging materials, raw materials, bulk products and finished products. Do the Instructions for each product(s) describe in detail operations concerning the manufacturing process and packaging, the resources to be used and methods to be applied.
C A B
Emulsification reaction workshop : The previous production material was not cleared from the production area.
1.5.4.6 1.5.4.7
1.5.5
B B
1.5.7
1.5.8
1.5.8.1
Processes
Are processes used in manufacturing, packaging, storage (of raw materials, bulk products and finished products), the maintenance of apparatus, buildings etc. clearly described. Is provision made for the updating and control of all documents. Are procedures and instructions adequately filed.
1.5.8.2 1.5.8.3
B B
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2.0 Purchasing:
No
2.1
Checkpoint
Contract Requirements
Are procedures laid down stating the responsibilities for: The establishment of specifications concerning raw materials, packaging materials, manufacturing apparatus and subcontracting. The establishment of technical contract clauses (the type of inspection to be carried out, acceptance and rejection criteria, provisions in the event of non-conformity or modification). Approval of Suppliers or Subcontractors (Quality and Quality Assurance): Purchase orders may be placed only for specified supplies from suppliers previously approved, preferably by the Manufacturer. The establishment of the type of relations and exchanges between Customer / Supplier (assistance, audit), the prohibition of subcontracting without the Customers consent. The inspection and testing on the premises of the supplier or subcontractor, and the audit of their Quality System.
Score
2.1.1
B B
2.1.2
2.1.3
2.1.4
2.1.5
Purchase Documents
Do the purchase documents contain data clearly describing the product. Does the procedure clearly define the responsibilities as regards the formalization of the deed of purchase, the type of information necessary, requirements, quality references, the method of circulation and dissemination (internal or external) of orders placed.
B B
3.0 Manufacturing:
No
3.1
Checkpoint
Receipt of Incoming Goods
Doc No.: GMPC Version: 001
Score
Page 6 of 35
B B B
3.1.2 3.1.3
3.1.4
B B B B B B B C B
In coming Material Storage: Many barrels of raw materials did not cover the lid.
3.1.4.1 3.1.4.2
3.1.5
3.1.6
3.1.7
3.2 3.2.1
Water
Water production and supply systems should provide at all times water of a quality, which will guarantee the conformity of the manufactured products.
3.0 Manufacturing:(Contd)
3.2 3.2.2
Water (Contd)
Are the water supply systems able to be disinfected in accordance with established procedures. Are pipes designed to avoid stagnation and risks of contamination. Are the materials used selected to ensure that the quality of the water will not be affected. Are there suitable markings to identify the pipes carrying water for manufacturing purposes (hot, cold, demineralized), cleaning water, cooling
B B B B
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The third party test report for purified water was not available . The factory claimed that they would send purified water to the third party each month for test . The test report was not retained .
B C B B B B B B B
Incoming Material Warehouse: the area marked as broken glass processing area is indeed stored the other items.
3.3.7 3.3.8
3.3.9
3.3.10
In coming Material Storage: Many barrels of raw materials did not cover the lid.
3.3.11
3.3.12
1) Incoming Material Storage: one pallet of barrels without making any identification. 2) Product ID: All products or materials not specifically identified as acceptable goods or defective goods. 3) Incoming Material Warehouse: the area marked as broken glass processing area is indeed stored the other items. 4) Incoming Material Warehouse: the region identified as defective are actually racked the qualified product.
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3.0 Manufacturing:(Contd)
No
3.4 3.4.1
3.4.1.1
Checkpoint
Manufacturing Process Preparation
Are all raw materials used identified and quantified in accordance with the formula. Are the raw materials listed in the formula measured or weighed: Either in clean, suitable containers labeled with any necessary information, e.g. identification and safety requirements. Or directly in the apparatus used for the manufacturing process. Are raw materials handled so as to avoid contamination. If packaging has been opened, has it been properly closed and restored to stock in conditions avoiding any risk of impairment of its content and be re-entered into the stock management system
Score
B B B
3.4.1.2
3.4.1.2.1
3.4.1.2.2
B B B
3.4.2 3.4.3
3.5 3.5.1
3.5.1.1 3.5.1.2
B B B B C
1)Emulsification reaction workshop : The previous production material was not cleared from the production area.
3.5.2
B B B
3.5.2.1 3.5.2.2
3.0 Manufacturing:(Contd)
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3.5.2.4
3.5.3
3.6 3.6.1
3.6.1.1
B B B B B C
1) Packaging Workshop: a barrelhead was found at the underground of machine which full of dust. 2) Packaging Workshop: 2 barrels of the production samples were not removed without making any identifications
3.6.1.2 3.6.1.3
The storage conditions. The tests carried out in the event of prolonged storage.
Packaging
Before any packaging operation, is the apparatus inspected for conformity. Are all components required for packaging properly identified. Are the necessary precautions taken to ensure proper line clearance (packaging materials and bulk products).
3.7.4
Is the designation of a product to be packaged indicated on the line or at the point of packaging.
3.8 3.8.1
3.0 Manufacturing:(Contd)
3.8 3.8.2
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3.8.3
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Checkpoint
Are all subcontracted operations properly specified so as to conform to the product quality specification. Has the Contractor and Subcontractor drawn up a preliminary agreement and a specification book stating the conditions required for manufacturing of the product concerned, and outline their respective responsibilities. Are the responsibilities defined in the contract binding the two parties: Does the Contractor evaluate the Subcontractors ability to fulfill the contract and ascertain that the Subcontractor has the necessary buildings, apparatus, personnel etc. Does the Contractor provide the Subcontractor with all information required for manufacturing. Does the Subcontractor comply with the procedures set out in the specification book. Does the Subcontractor facilitate inspection and audit as requested by the Contractor or as agreed to in the specification book.
4.2
4.3 4.3.1
N/AP N/AP
N/A
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Page 12 of 35
Checkpoint
Introduction
Does the Quality Management cover all the functions of the company. Has the manufacturing department adopted and observe written procedures and instructions. Does the Manufacturing staff participate in the preparation and drafting of procedures and instructions.
Score
B B B
5.2 5.2.1
Quality Control
Are the results of inspections and the representative samples of batches of raw materials, packaging materials, bulk products and finished products which have been inspected, recorded and properly stored. Do Control Laboratories assist the manufacturing department through: Optimization of the manufacturing processes. Analysis of manufacturing problems. Participation of quality audits. Are all inspection conducted in accordance with written procedures.
B B B B B B B B B C B
Incoming Material Storage: one electronic balance missed the calibration identification .
5.3.3
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Page 13 of 35
Do Calibration procedures define: The name of the apparatus. Its reference number if necessary. The calibration instructions. The calibration frequency and tolerance range. The measures to be taken if the calibration tolerances are exceeded. Is each piece of apparatus to be calibrated carrying a label stating: The date of the last calibration. The initials of the person who conducted the calibration. The date of the next calibration. If any apparatus exceeds the tolerances, is it clearly identified as such. Is each modification made on the apparatus properly recorded. If necessary after modification, is the apparatus re-calibrated. Do Reagents and solutions carry a label stating The name of the product. Its strength or degree of concentration. Its expiration date. The initials of the person who prepared it. Are written instructions for inspection available in the Laboratory.
B B B B B B B B B B B B B B B B B B
5.3.6
5.3.6.1 5.3.6.2 5.3.6.3 5.3.6.4 5.3.6.5 5.3.6.6
5.3.7
5.3.7.1 5.3.7.2 5.3.7.3 5.3.7.4
5.3.8
Checkpoint
Control Activities
(Activities conducted by Control Laboratories and manufacturing Staff in order to supervise quality during manufacturing) Does the Laboratory and Manufacturing staff have the following information available: The specifications. Sampling Procedures. Inspection Methods. Established limit values. Instructions for the use of the Control Laboratories. Procedures for calibration and maintenance of the control instruments. Instructions for monitoring of the quality during manufacturing.
Score
5.4.1
5.4.1.1 5.4.1.2 5.4.1.3 5.4.1.4 5.4.1.5 5.4.1.6 5.4.1.7
B B B B B B B
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Do the specifications contain: The internal code number or designation adopted by the Factory. The qualitative and quantitative characteristics, with their established limit values. Frequency of re-inspection as appropriate. Reference(s) to the methods to be used for required determination. Special sampling instructions. How does the Factory determine the following: Conformity: Acceptance. Major Non-conformity: Rejection. Minor Non-conformity: In the case where nonconformity will not influence the quality of the finished product, the batch may be accepted on an exceptional basis. This should be noted in the documents relating to the batch. Acceptable criteria for noon-conformity which are acceptable should be agreed with the client beforehand ! Are the persons entitled to grant authorization for use identified.
B B B B B B B B B
5.4.3
5.4.3.1 5.4.3.2 5.4.3.3
5.4.4
5.4.6 5.4.7
B B
5.5 5.5.1
5.5.1.1 5.5.1.2 5.5.1.3 5.5.1.4
Control Records
Do the control records include at least the following information: Designation (internal code number, trade name etc.) The batch number and date. The references to the specifications and inspection methods. The results of all inspections, measurements or verifications performed, the initials, and the observations of the persons having carried them out. In the case of acceptance testing, the decision to accept or reject should be stated very clearly.
B B B B
5.5.1.5
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B B B B B B B B
5.6.1.5
5.6.2
5.6.2.1
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5.6.2.3 5.6.2.4
5.6.3
B B B
B B B B
5.6.7
5.7 5.7.1
5.7.1.1 5.7.1.2
B B B B
5.7.1.3
B B B
5.8.1.1.1
5.8.1.1.2
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5.8.1.2
5.8.2
5.8.2.1
Document Management
Are all documents regularly updated.
1)Document Management: All the manuals, and procedure files from the release date were not updated and revised. Management representative has resigned in July,2009.But the previous management representative still listed at the quality manual. Management representative is currently vacant. 2) The Quality manual only showed the quality objective of 2008. The 2009 quality objective was not available.
5.8.2.2
Are all out-of-date documents immediately withdrawn to avoid their use. Is the inventory of documents kept up-to-date. Is the Document Management based on a procedure defining in particular: The person(s) who draw up and endorse the documents before dissemination. The person(s) to whom the documents will be addressed. The location and method of filing. For all modifications, is the following information should be given: The nature of the changes. The person(s) responsible for the changes. The reason for the changes. The revision number and date of application.
B B B B B B B B B B B
5.8.2.2.1 5.8.2.2.2
5.8.2.2.3
5.8.2.2.4
5.8.2.2.5
5.8.2.2
5.8.2.2.1 5.8.2.2.2 5.8.2.2.3 5.8.2.2.4
5.9 5.9.1
5.9.2
B B
5.9.3
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5.10.1.2
Are these designed for easy cleaning and disinfection. Is Apparatus accessible for cleaning and disinfection.
C C
5.10.1.3
The facet installed in the hand washing basin for Emulsification reaction workshop was found the no water out. And no alcohol inside the alcoholic bottle. However, the work instructions require hand-washing and disinfection with 75% alcohol. The garbage was burning in the surrounding area of the building during audit. The waste treatment is not according to operating instructions required. 1(Filling Workshop C line: a large number glue of transparent plastic was stuck on the metal surface of the machine was not removed. 2) Packaging Workshop and filling workshop: The daily cleaning & sterilization and maintenance record for machine and facility was not available from October to December . 3) SOP of cleaning & sterilization provide limited details against different component including plastic and glass bottle. 1)Pest control records was ended in June. The records for afterwards month was not available. However, the work instruction required each month to conduct the contractual insecticidal activity. 2) Pest Control sub-contract expired in 2009-10-13. Factory did not renew the contract with the subcontractor. 1Aging room: a large number of fluid was leaked on the ground during audit. The detailed written procedure for cleaning & sterilization clothes and towels not available .But the daily cleaning & sterilization record was retained. 1) Packaging Workshop and filling workshop: The daily cleaning & sterilization record of clothes, towels, was not available from October to December.
5.10.1.4
Are provisions made to prevent infestation by parasites, insects, rodents, birds etc.
5.10.1.5
Are routine inspections carried out to detect their presence. Are written procedures describing cleaning and disinfection techniques followed in all stages of manufacturing.
C C
5.10.1.6
5.10.2
5.10.2.1
Hygiene of Personnel
Do person(s) coming into direct contact with cosmetic materials, finished products in bulk or cosmetic surfaces, to the extent necessary to prevent adulteration of cosmetic products observe the following:, , gloves, hair restraints etc., and maintain adequate personal cleanliness: Wear clean, suitable clothing. Wear gloves. Wear hair restraints / beard snoods. Jewelry should be removed, no rings, earrings, necklaces, bracelets & watches.
5.10.2.1.1
C B B C
1)Filling workshop: The clothes was hanging in the filling workshop during audit.
The factory claimed that the factory have conducted the foreign body contamination control such as
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5.10.3
5.10.4
Are all cases of illness or injury, which could influence production reported so that measures can be taken to ensure that product quality is not affected. Is eating, drinking and smoking permitted only in suitable designated areas separate from the manufacturing areas.
5.11 5.11.1
Audits
Are audits conducted independently and in depth, regularly or on requested, by competent person(s) appointed for the purpose.
The factory provided vendor evaluation records . But the finance staff involved the evaluation, which was incompatible with her duties.
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Audits (Contd)
Are audits conducted on the site of manufacturing or on the premises of the Subcontractor(s) and component Supplier(s). Do audits concentrate on the Quality System in general Are the audit results forwarded to the Senior Management and communicated to staff members concerned, so that improvements can be implemented. Is a check carried out to ensure that the improvements are in fact carried out.
5.11.3 5.11.4
B B
5.11.5
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Priority
Details
1. Required (3 months) / 2. Advised / 3. Suggested
1 1 1 1
6.2 6.3
6.4
6.5 6.6
1 1 1 1 1 1 1
Doc No.: GMPC
6.10
6.11
The garbage was burning in the surrounding area of the building during audit. The waste treatment is not according to operating instructions required. 2009 Annual Training Records: Training records only have the training title, no included the content and personnel involved Supplier Assessment: The factory provided vendor evaluation records . But the finance staff involved the evaluation, which was incompatible with her duties. Document Management: All the manuals, and procedure files from the release date were not updated and revised. Management representative has resigned in July,2009.But the previous management representative still listed at the quality manual. Management representative is currently vacant. The Quality manual only showed the quality objective of 2008. The 2009 quality objective was not available. Pest control records was ended in June. The records for afterwards month was not available. However, the work instruction required each month to conduct the contractual insecticidal activity. Pest Control sub-contract expired in 2009-10-13. Factory did not renew the contract with the sub-contractor. Emulsification reaction workshop : The previous production material was not cleared from the production area. Emulsification reaction workshop : The emergency indicator made by glass was found broken . The broken was not cleared out of the production area. The facet installed in the hand washing basin for Emulsification reaction workshop was found the no water out. And no alcohol inside the alcoholic bottle. However, the work Instructions require hand-washing and disinfection with 75% alcohol. Product ID: All products not specifically identified as acceptable goods or defective goods.
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1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Doc No.: GMPC
Incoming Material Warehouse: the region identified as defective are actually racked the qualified product. Incoming Material Warehouse: the area marked as broken glass processing area is indeed stored the other items. Incoming Material Storage: one pallet of barrels without making any identification. Incoming Material Storage: one electronic balance missed the calibration identification .. In coming Material Storage: Many barrels of raw materials did not cover the lid. Filling workshop: The clothes was hanging in the filling workshop during audit. Aging room: a large number of fluid was leaked on the ground during audit. Filling Workshop C line: a large number glue of transparent plastic was stuck on the metal surface of the machine was not removed. Packaging Workshop: a barrelhead was found at the underground of machine which full of dust. Packaging Workshop: 2 barrels of the production samples were not removed without making any identifications Packaging Workshop and filling workshop: The daily cleaning & sterilization and maintenance record for machine and facility was not available from October to December . Packaging Workshop and filling workshop: The daily cleaning & sterilization record of clothes, towels, was not available from October to December . Toilet sink was not equipped with Dryers and papers. Toilet (male) opened windows and screens. There is no clear requirement regarding how to handle such kind of unexpected broken with glass bottle The factory claimed that the factory have conducted the foreign body contamination control such as wearing control .But the written procedure was not available. SOP of cleaning & sterilization provide limited details against different component including plastic and glass bottle.
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6.23
6.29
1 1 1
6.31
6.32
The third party test report for purified water was not available . The factory claimed that they would send purified water to the third party each month for test . The test report was not retained . The detailed written procedure for cleaning & sterilization clothes and towels not available .But the daily cleaning & sterilization record was retained. One health certificate was expired .The issuing date was 2008-0414.The expired date was 2009-04-13.
Details
6.2 Enclosures:
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PHOTO ATTACHMENT
3 Health License
5 Organizational code
6 GMPC certificate
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10 garbage burning
11 factory office 1
12 factory office 2
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19 the dryer
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36 filling workshop 1
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37 filling workshop 2
38 hygrothermograph
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