口香糖公司质量管理系统要求31192.pdf

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1、 W Q M S 1 2 0 0 5/2 7/0 2 F a c t o r y D o c u m e n t C o n t r o l&R e v i s4.1 Controlled documents generated outside the Factory shall be controlled by the originating organizationR&D,CQA)to assure the most current approved documents are available to the Factory.Factory Manashall meet the docu

2、ment control requirements of the originating organization.The documents shmaintained as confidential,secured,and protected from damage.Examples of controlled documents follows:4.1.1 Formulas 4.1.2 Manufacturing Procedures 4.1.3 Analytical Test Methods 4.1.4 Ingredient&Finished Product Specifications

3、 4.2 Factory controlled documents shall meet the following requirements:4.2.1 Examples of Factory documents are as follows:4.2.2 Documents shall be authored by persons knowledgeable in the subject matter of the documen4.2.3 Documents shall include,but not be limited to:4.2.4 Documents shall be regul

4、ated to maintain security and confidentiality,and protected from damage.4.2.5 A change to Factory documents shall include:4.3 The Factory shall have documented procedures for:4.3.1 Identifying controlled documents 4.3.2 Scheduled review/revision of documents 4.3.3 Marking and control obsolete docume

5、nts 4.3.4 Assuring the most current issue is available at point of use 4.4 The Factory shall have a documented procedure for archiving documents which includes,but is not lto:Responsibilities Method Location 4.5 Archiving methods include maintaining:Hard copies Microfilm Electronic files 4.6 Factory

6、 records shall be maintained for current year plus 3 years or as required by local authorwhichever is greater.WQMS 130 01/05/01 Record Keeping 4.1 Records shall be:4.1.1 Legible 4.1.2 Written in permanent ink other than red,or electronic 4.1.3 Easily retrievable 4.1.4 Stored and protected against da

7、mage end theft WQMS 130 01/05/01 Record Keeping(Continued)4.1.5 Restricted in access 4.1.6 Signed by person(s)entering information 4.2 Information on records shall not be eradicated in any way.This includes,but is not limited to:4.2.1 Erasures 4.2.2 Correction fluid,correction tape,or equivalent 4.2

8、.3 Write-overs 4.3 Changes to records shall include one line through the item in error,the correct information written in close prand the initial/date of the person making the change.4.4 Records shall be maintained for current year plus 3 years,or as required by local authorities,whichever is greWQM

9、S 210 11/29/00 Stage System STAGES V,Vl,Vll 4.1 CQA and Factory Management shall meet the requirements of CQAP 210.04:Corporate Quality Assurance PScale-Up and Release Protocol for product launches as determined and agreed upon by CQA.4.2 Stage V-Extended Run 4.2.1 Each Factory shall have a procedur

10、e in place to monitor Stage V trials and provide samplinformation as defined by R&D.4.2.2 Each Factory shall report results of Stage V trials to Product Launch Committee.4.2.3 CQA and Factory Management shall review proposed R&D specifications and provide recommendatthe Product Launch Committee for

11、concurrence before proceeding to the next Stage.4.2.4 CQAP 210.01 Stage V to VI Procedure shall be followed 4.3 Full Production 4.3.1 Each Factory shall have a procedure in place to monitor Stage VI trials and provide samples4.3.2 CQA and Factory Management shall review:(CQAP:210.03:Retail Sample Co

12、llection and Shipment Procedure)4.3.3 CQA and Factory Management shall provide a recommendation to Product Launch Committeeproceeding to the next stage 4.3.4 CQAP 210.02:Stage VI to Stage VII Procedure shall be followed 4.4 Steady State 4.4.1 CQA and Factory management shall continue to monitor ongo

13、ing production CQAP 210.01 10/05/01 Stage V to VI Procedure 4.1 CQA shall confirm with Factory Management that a HACCP system is in place.4.2 CQA Sensory:4.2.1 CQA Sensory shall be trained by R&D on product sensory requirements.4.3 Finished Product Specification(as defined by wrapped gum):4.3.1 CQA

14、shall concur with R&D on the Finished Product Specification.4.4 Formula 4.4.1 CQA is responsible for issuing formulas to the Factory(See Section 4.9).4.5 Manufacturing Procedure:4.5.1 CQA shall concur with R&D on the Manufacturing Procedure 4.6 New Ingredient 4.6.1 New ingredients shall be evaluated

15、 and determined to be acceptable before proceeding to Stfollowing CQAP 610.14:Qualification Procedure:Ingredients 4.7 New Manufacturing Equipment 4.7.1 Factory Management shall verify that equipment is designed under GMP requirements,meetsintended use,and can produce a product within specification.4

16、.8 Packaging:See CQAP 610.15:Qualification Procedure For Packaging Materials.4.9 After the CQA responsibilities have been met,the Project Manager approves the Stage VI formula,indiCQA concurs with proceeding to Stage VI.CQAP 210.02 02/23/98 Stage VI to VII Procedure 4.1 Preliminary considerations 4.

17、1.1 CQA shall confirm with Factory Management that a HACCP system is in place 4.1.2 The product shall have an appropriate priority(A(highest),B,or C)as assigned by the New PrCommittee and communicated by Corporate Development in their Bi-Weekly Product Development TrReport,to proceed with the Stage

18、VI to VII evaluation.Based on this priority,the approSections 4.2 through 4.6 will be followed.4.2 Increased Sampling of Finished Product 4.2.1 Applies to A priority products only 4.2.2 The Factory submits two(2)samples from each of the first three(3)Stage VI runs to CQA for stesting and analytical

19、testing.4.2.3 Results are evaluated by CQA to determine if specifications are met 4.3 Retail gum pick-up 4.3.1 Applies to A&B priority products only 4.3.2 Product pick up is coordinated by CQA(See CQAP 210.03:Retail Sample Collection and ShProcedure)4.3.3 Samples are sent to and analyzed by CQA 4.3.

20、4 Results are evaluated by CQA to determine if specifications are met.4.4 Factory In process and Finished Product Capability Study 4.4.1 Applies to A,B,&C priority products if the study has not been previously done in Stage V fproduct type for that Factory 4.4.2 Factory collects process data and sam

21、ples from specified Stage VI production runs 4.4.3 Samples and data are analyzed by CQA 4.4.4 Results are evaluated by CQA to determine if specifications are met.4.5 Consumer Complaint Review 4.5.1 Applies to A,B&C priority products 4.5.2 Consumer complaints for the product under evaluation are anal

22、yzed and summarized by local QA Complaints are presented as a rate(complaints per million boxes),if available.Where appropaction plans are developed with the Product Launch Team.4.6 Monthly Gum Review 4.6.1 Applies to A,B&C priority products 4.6.2 Monthly gum results are reviewed by CQA 4.6.3 Result

23、s are evaluated by CQA to determine if specifications are met.4.7 Overall Review 4.7.1 CQA shall use an internal tracking report to monitor progress of Sections 4.2 through 4.64.7.2 Results from above are complied by CQA,with a recommendation to proceed to Stage VII or reStage VI for further review.

24、This is presented to the Product Launch Committee.4.7.3 Product Launch Committee decides if moving to Stage VII is appropriate.CQAP 210.03 08/14/02 Retail Sample Collection and Shipment Procedure 4.1 Sampling:4.1.1 One retail sample shall be picked up from a minimum of three separate points of purch

25、ase specified market area.4.1.2 Each retail sample shall be placed in a top-loading envelope,sealed labeled and individuallyinto a plastic bag.4.1.3 Samples shall not be subjected to adverse conditions(e.g.,sunlight,extreme heat,cold)folcollection from the point of purchase.4.1.4 A photo of the disp

26、lay area from which the samples are collected shall be provided if an icamera is available The photos shall be labeled and enclosed in a separate envelope and shippthe corresponding sample.CQAP 210.03 08/14/02 Retail Sample Collection and Shipment Procedure(Continued)4.2 Labeling:4.2.1 A label shall

27、 be completed and attached to each sample envelope.4.2.2“Other Comments”portion of the label shall include comments about the condition of the pdisplay,and any other sample information about the sample or its environment.4.3 Shipping:4.3.1 Retail sample collected from each market area shall be shipp

28、ed together to Factory QA.4.3.2 Samples shall be placed in heavy corrugated Wrigley gum cases or standard shipping cartons.use any case,crate,or carton that previously contained any non-food material.Do not use ancrate,or carton that has an off-odor.4.3.3 Standard packing materials shall be used to

29、protect samples during shipping if necessary Styrofoam,plastic packing bubbles).Do not use newspapers or other non-standard packing matwhich may impart off-odors onto the products.4.3.4 All samples collected shall be shipped directly to Factory QA immediately following collectbest means to ensure ar

30、rival within one week of collection.CQAP 210.04 11/29/00 CQA Scale Up And Release Protocol 4.1 Corporate QA shall follow this procedure for major product launches as determined and agreed upon by CorQA Management.4.2 Establishing a Corporate QA Project Team 4.2.1 Once the Corporate QA Project Manage

31、r obtains confirmation that the project has been approupper management,he/she shall assemble representatives from each CQA Group to establish Project Team.4.2.2 The CQA Project Team shall be as follows:Laboratory Packaging Projects Sensory 4.3 Requirements of the CQA Project Team 4.3.1 The CQA Proje

32、ct Team shall determine a Team name that differentiates itself from other projects4.3.2 The agenda for the first team meeting shall include:4.3.3 At each meeting,the CQA Project Team shall determine:4.3.4 The CQA Project Team shall determine when CQA accepts product scale-up and release responfrom R

33、&D.This decision shall be communicated to R&D by the CQA Project Manager.4.3.5 The CQA Project Team shall establish and document the Short Term and Long Term Protocproduct scale-up and release to:4.3.6 The CQA Project Manager shall obtain information concerning R&Ds scale-up release critinclude:CQAP

34、 210.04 11/29/00 CQA Scale Up And Release Protocol(Continued)Analytical Sensory WQMS 220 12/29/99 Inspections by Food Regulatory Agencies 4.1 The Factory shall have a documented procedure for conduct of inspections by food regulatory agenc4.2 Factories shall notify CQA of regulatory agency visits.4.

35、3 The procedure shall define responsibilities and requirements for the following phases:4.3.1 Pre-Inspection 4.3.2 Inspection 4.3.7 The CQA Project Team shall obtain information from R&D which includes:4.3.8 The CQA Project Team will review and monitor the reported results from the Short Term PrNext

36、 steps may include:4.4 The Product Scale-up and Release Protocol shall be divided into two sections:Short Term and Long Te4.4.1 The Short Term Release Protocol shall include and define the following:4.4.2 The Long Term Release Protocol shall be contingent upon results from Short Term Release PrThis

37、section shall include the following:4.5 The CQA Project Manager shall distribute the CQA Product Scale-up and Release Protocol(Short TeLong Term)to the Factory QA Manager(cc:CQA Project Team,Factory QA Staff).4.6 The CQA Project Manager shall require a written response from the Factory QA Manager in

38、dicating agreto comply with the CQA Product Scale-up and Release Protocol.4.7 Following Factory(s)concurrence with the Product Scale-up and Release Protocol,the CQA Project Mshall issue the final version of the protocol to the distribution copy list(cc:CQA Management,FManager,Factory QA,Regulatory A

39、ffairs Manager,R&D Process Research Manager,R&D Product DevelManager).4.8 Documents used to track results shall be issued by the CQA Project Manager along with instructions fo4.9 CQA and the Factory shall document results,and next steps of both the Short Term and Long Term Protobe communicated to th

40、e Factory by the CQA Project Manager.4.10 Any revisions to the protocol shall be documented and issued by the CQA Project Manager to distribution copSection 4.7.4.3.3 Post-Inspection 4.4 The detailed procedure that shall be followed is CQAP 220.01:Food Regulatory Inspection Procedu4.5 Any local regu

41、lations shall be incorporated into the Factory procedure for handling inspections by food regagencies.This Factory procedure must get Corporate approval prior to implementation.4.6 A summary of any food regulatory agency inspections shall be included in the Factory Monthly Report per 230:Factory Qua

42、lity Report.4.7 Nonconformances are subject to corrective action(see WQMS 560:Corrective Action).CQAP 220.01 10/05/01 Food Regulatory Inspection Procedure 4.1 The Factory shall have a documented procedure for conduct of inspections by food regulatory agenciesprocedure shall include,but is not limite

43、d to the following:4.1.1 Responsibilities for pre-inspection,inspection and post-inspection 4.1.2 Any additional local regulations with respect to inspections by food regulatory agencies 4.1.3 The requirement to notify CQA of differences in this procedure and local regulations 4.2 Pre-Inspection 4.2

44、.1 There shall be prompt notification of the appropriate management personnel when visited byregulatory agency.Any person who might initially meet an inspector shall be trained accord4.2.2 Factory Management shall designate a person who will have the primary responsibility for handlinRegulatory Agen

45、cy inspections.(In the remainder of this document,the individual to whom this respois delegated in a particular inspection situation shall be referred to as the“manager”).4.2.3 Factory Management shall assure that the manager or designee is accessible whenever an inspepresent.4.2.4 The manager shall

46、 understand internal and operating procedures of food regulatory agencie4.2.5 The inspector,before being given any information or admitted to the plant,must presentcredentials.The inspector may also present a written notification of inspection(e.g.,States FDA Form 482).4.2.6 The inspectors credentia

47、ls or authority may be confirmed by a telephone call to the apprregulatory agency.4.2.7 Inspectors shall not be kept waiting any longer than 15 minutes.4.3 Inspection:4.3.1 The manager shall inquire as to the purpose and scope of the inspection.4.3.2 The manager shall accompany the inspector through

48、out the inspection at all times.If there is more th(1)inspector,each must be accompanied.4.3.3 The inspector shall be shown only the requested areas of the plant,provided such items fall within theof inspectors legal authority.4.3.4 Certain documents are prohibited by Company policy from being viewe

49、d by inspectors.These includ 4.3.5 Company policy prohibits photography and use of audio recording devices during inspections.4.3.6 Requests for information listed under 4.3.4 or photography and audio recording shall be directed to C4.3.7 Upon request,the following information may be made available

50、to an inspector without restriction:CQAP 220.01 10/05/01 Food Regulatory Inspection Procedure(Continued)4.3.7.1 Company details such as:Corporate name of the company Place of incorporation Names of company officers Lines of authority within the company Types of products produced in the plant Name of