Site Quality Self-Assessment
Site Quality Self-Assessmentbased onRx-360 Supplier Assessment QuestionnaireModule 2, Site Specific InformationRelevant for8511 West Riggin AveVisalia, CA 93291USAThe site self-assessment covers our quality managementsystem for the following applications:- distributionMerck KGaA, Darmstadt, Germany is anactive member of the Rx 360 Consortium.As a trusted partner of our customers, we deliver quality- always.Merck KGaA, Darmstadt, GermanyCorporation with General PartnersFrankfurter Str. 25064293 Darmstadt, GermanyPhone 49 6151 72-0Sigma-Aldrich CorporationA subsidiary of Merck KGaA, Darmstadt, Germany3050 Spruce StreetSt. Louis, MO 63103, USAPhone 1 (800) 521-8956 / 1 (314) 771-5765Site Self-Assessment Visalia version 1.0EMD Millipore CorporationA subsidiary of Merck KGaA, Darmstadt, Germany400 Summit Drive Burlington,MA 01803, USAPhone 1 (781) 533-6000
InformationThis document is based on the Rx-360 Consortium’sSupplier Assessment Questionnaire template, Module 2.The contents of this questionnaire are built on the Rx-360questionnaire version 2.0 intact with no question added ordeleted.Rx-360's CEO/COO gave permission to Life Science to usethe Rx-360 logo.Merck KGaA, Darmstadt, Germany is anactive member of the Rx 360 Consortium.Merck KGaA, Darmstadt, GermanyCorporation with General PartnersFrankfurter Str. 25064293 Darmstadt, GermanyPhone 49 6151 72-0Sigma-Aldrich CorporationA subsidiary of Merck KGaA, Darmstadt, Germany3050 Spruce StreetSt. Louis, MO 63103, USAPhone 1 (800) 521-8956 / 1 (314) 771-5765Site Self-Assessment Visalia version 1.0EMD Millipore CorporationA subsidiary of Merck KGaA, Darmstadt, Germany400 Summit Drive Burlington,MA 01803, USAPhone 1 (781) 533-6000
Rx-360 Supplier Assessment Questionnaire :Site-Specific InformationPlease check here if additional documents are attached.SECTION 1. General Site Information1.1Site or Facility-Specific Name:MilliporeSigma - Visalia Disribution Center1.2Address: 8511 West Riggin Ave Visalia, CA 93291GPS Coordinates:36.3559724677438, -119.385809943481.3Phone:Please refer to your local Sales Representative1.4Email:Please refer to your local Sales .comSECTION 2. General Site Operating Information2.1What year did the site start operating? December 20192.2What is the primary activity of the site? (e.g. manufacturing, distribution, etc.)Distribution2.3To which, if any, subdivision of the parent company does the site belong?MilliporeSigma, a subsidiary of Merck KGaA of Darmstadt, GermanyVisalia Site Self-Assessment version 1.03 of 12
SECTION 2. General Site Operating Information2.4Size of site (in sq. ft. or m.): 125,000 sq ft2.5Please list or attach the normal hours/schedule of the facilities, including shutdowndates (if applicable):Monday - Friday 8:00 AM to 5:00 PM2.6Total number of employees on site:252.7Total number of employees in Quality:12.8Total number of employees in Manufacturing:02.9What quality management system is utilized on site?ISO 9001ISO 1348521 CFR Part 210/21121 CFR Part 820European GMP, Eudralex Volume 4 Part IEuropean GMP, Eudralex Volume 4 Part IIICH Q7HACCPISO 22000OtherPlease describe:Which Regulatory Initiatives does the site follow/comply with?REACHRoHsCa Prop. 65WEEE2.10Does the company/sitehave an export license?Visalia Site Self-Assessment version 1.0YesNoN/A4 of 12
SECTION 2. General Site Operating Information2.11Is the site registered with any government regulatory agency (FDA registration,GMP certification, etc.)?YesNoN/AIf yes, please specify.Registered with FDA, California Department of Public Health , California AirResources Board, ATF and Department of Homeland Security.2.12By whom is the site inspected (regulatory or third party) and list inspections withinthe last three years:ISO 9001: October 2020FDA: Registered and yearly inspection expectedCDPH: Registered and yearly inspection expectedDHS: March 20212.13How often, as an annual average, is the site audited by customers or third parties?Expect 1-2 a year2.14Has an Rx-360 audit been performed at this site?Please also state the date of the audit if .152.162.172.18Are you willing to have Rx-360 conduct an audit on behalf of your customersaccording to the Rx-360 audit programs on your site?YesNoAre you willing to have your customers conduct audits on your site?YesNoPlease list regulatory sanctions impacting the site within the last five years (i.e.warning letters, CEP suspension, import alerts, etc.):NoneDoes the site outsource any quality-related activity?YesNoN/AIf answering yes, please specify the activities:Calibration of temperature probes and scales.Visalia Site Self-Assessment version 1.05 of 12
2.19SECTION 2. General Site Operating InformationPlease check the supplier controls in place for this facility:2.19a Quality Agreements withSuppliersYesNoN/A2.19bSubcontractor Qualification/AuditProgramYesNoN/A2.19cPeriodic Review of SupplierPerformanceYesNoN/A2.19dSupplier Feedback ProgramYesNoN/A2.19eApproved Material Supplier ListYesNoN/AYesNoN/A2.19f Approved Service Supplier ListAdditional comments:Approved Supplier Lists held in ERP (SAP)3.1SECTION 3. Objectionable Materials on SiteDoes the site or production plant produce,process or store any of the 1f3.1gBeta-Lactam AntibioticsSteroids and/or hormonesHigh potency compoundsMaterials of animal origin/BiologicsLive virus or micro-organismAllergens3.1hAgrochemicals (Pesticides, Herbicides,Fungicides, etc.)Other (Please specify):As one of the main distribution centers for MilliporeSigma, the Visalia sitedistributes a large selection of products from a catalog of over 250,000 products,primarily used for scientific research. It is expected as inventory expands that someof above product categories may be added.3.1iGenetically Modified Organisms (GMO)Visalia Site Self-Assessment version 1.06 of 12
SECTION 4. Cross Contamination ControlAre any of the following crossNotYesNocontamination controls in place?Applicable4.1aDedicated Facilities4.1bAccess Controls4.1cDedicated Personnel4.1dDedicated Gowning4.1eProcedural Controls4.1fOther (please specify): .Additional Comments: Materials received at the site are closed bottles/containers withtamper evident seals, and no operation involves opening product on-site.4.15.1SECTION 5. Site Operating PoliciesDoes the site utilize the following written policies, programs, or procedures?Site ntal, Health, and SafetyFacility Environmental Control PolicyGeneral Facility Cleaning ProceduresHygiene and Sterilization ProceduresValidated Equipment Cleaning ProceduresPreventative Maintenance Program/ProceduresPest Control ProgramMaster Production .1s5.1t5.1u5.1v5.1w5.1xQuality Control/Quality Management PolicyQuality ManualPeriodic Product Quality ReviewMaster Validation PlanRisk Assessment ProgramSupplier Approval ProcedureMonitoring and Review of Approved SuppliersMechanism to Reduce TestingReceiving Incoming InspectionChange Control ProceduresDocument Management PolicyDocument Retention PolicyChange Notification Procedures for ClientsControl of Nonconforming MaterialDeviation/Investigation ProcedureOut of Specification Policy and ProcedureQuality:Visalia Site Self-Assessment version 1.0YesNoNotApplicable7 of 12
5.1y5.1z5.1aa5.1bb5.1cc5.1dd5.1ee5.1ffSampling Procedure/Sampling PlanRaw Material Retention ProgramCAPA ProcedureLabel Control and AccountabilityProduct Release ProcedureEmployee Training ProgramStability, Expiration, and Shelf-Life ProgramProduct Retention Program5.1ggRecall Procedure5.1hhCustomer Complaint Handling5.1iiEquipment validation/qualification procedureSECTION 5. Site Operating PoliciesYes5.1jj5.1kk5.1llNotApplicableNoInternal audit/self-inspection programprocedureSite Security/Site Access Control PoliciesNew Hire Program/Induction ProgramBusiness Continuity/Contingency Plan:5.1mm5.1nn5.1oo5.1pp5.1qqDisaster Recovery PlanPandemic Preparedness PlanSupply Chain Emergency Preparedness PlanBusiness Continuity/Contingency PlanCan the company provide a plan upon request? OR provide a short descriptionbelow:Yes.SECTION 6. Quality Assurance and ProductionYes6.16.26.2a6.2b6.2c6.36.46.5Does the site have an independent and defined QualityAssurance/Quality Management Division?Does QA/QM have authority over the following:Policies and procedures?Review of documentation for release?Release or rejection of incoming materials?Does QA/QM investigate and resolve quality complaints?Does QA/QM investigate and resolve internal deviations?Does the QA/QM have the authority to assign a disposition tomaterials?Visalia Site Self-Assessment version 1.0NoNotApplicable8 of 12
SECTION 6. Quality Assurance and ProductionYes6.6Does the QA/QM review manufacturing and testing recordsprior to release?6.7Does the facility utilize computerized systems for managingGxP activities or data?6.8Are relevant computerized systems 21 CFR part 11 and EUGMP annex 11 compliant?6.9Does the site use statistical methods for consistency anduniformity?6.10Does the site use controlled documents for following andrecording manufacturing instructions?6.11Does the company qualify and/or validate manufacturingprocedures?6.12Is any environmental monitoring conducted inproduction/finishing areas?6.13 Does the site supply BSE/TSE declarations?6.14 Does the site supply a declaration of Elemental Impurities?6.15 Are ICH Q3C solvents used in the manufacturing process ofsupplied materials?6.15a If Yes, what class of solvent is used?6.16 Are stability studies carried out according to ICH guidance?6.17 Are solvents and mother liquor reused/recycled?6.18 Does the site have a process water treatment system?6.18a Please check all that apply to the system:City/potable waterDistilled waterDionized waterWater for injection (WFI)Reverse OsmosisClean steamUltra-filtrated water (purified water)Other:NoNotApplicable6.19 Does the plant have a batch/lot system?6.19a Is the system traceable?6.19b6.19c6.19d6.20Is it unique?Is batch/lot manufacturing continuous?Is manufacturing batch by batch?Does the site perform on-plant audits prior to approvingcritical GxP suppliers?Visalia Site Self-Assessment version 1.09 of 12
SECTION 6. Quality Assurance and .306.316.326.336.34Does the site audit critical GxP suppliers after initialapproval?Does the site inspect incoming materials?Does the site test incoming materials to definedspecifications?Does the site establish purchase specifications for rawmaterials?Is the equipment multi-use?Does the site qualify equipment installation?Does the site qualify equipment operation?Does the site qualify equipment performance?Are production critical use instruments calibrated regularly?Is rework allowed?Is reprocessing allowed?Are manufacturing and packaging activities traceable to theequipment, areas, and materials used?Are production materials handled and stored in a manner toprevent degradation, contamination and cross-contamination?If answering ‘not applicable’ for any of the above, please elaborate:NoNotApplicableAdditional Comments: Visalia is distribution site only - receiving and shipping finishedproduct.SECTION 7. Laboratory Procedures7.17.1a7.1b7.27.37.47.5Does the site have standard procedures for samplehandling/tracking?Does the site have standard procedures forretaining samples?Does the site have standard procedures for retesting samples?Does the site have written and approvedspecifications and test methods?Are laboratory instruments calibrated regularly?Is there a standard procedure in place foranalytical method development?Does the site qualify and/or validate analyticaltest procedures?Visalia Site Self-Assessment version 1.0YesN/A for this SiteNoNot Applicable10 of 12
SECTION 7. Laboratory Procedures7.6YesN/A for this SiteNo7.15Does the site perform stability testing onmaterials and/or products?Are retention samples of key raw materialsmaintained?Are standards traceable to their preparation andreagents used?Are retention samples of finished productmaintained?Are shelf life/retest/expiration dates available andstandardized?Does the company provide a certificate ofanalysis (CoA) and/or a Certificate ofConformation/Compliance (CoC) for each lot orbatch?Does the CoA/CoC contain the manufacturename and location?Does the CoA/CoC signed/e-signed by a Qualityrepresentative?If a repacker performs analyses, will the CoAreflect both the original manufacturing site dataas well as the repacking site data?If answering ‘not applicable’ for any of the above, please elaborate:7.16Additional Comments:7.77.87.97.107.117.127.137.14SECTION 8. Packaging, Storage, and Transport8.18.28.38.48.58.68.78.8Does the site have a validated or qualifiedlabeling system?Are batch production records retained andavailable?Are packaging and labeling areas separate fromproduction?Are barcode readers in use and challengedregularly?Are vision systems in use?Is product ever packaged without a label beinginitially applied (i.e. bright stocking)?Do labels include shelf life/expiration dates?Do labels include lot/batch number?Visalia Site Self-Assessment version 1.0YesNot ApplicableN/A for this SiteNoNot Applicable11 of 12
SECTION 8. Packaging, Storage, and Transport8.9Do labels include requirements for storageconditions?8.10Is tamper evident seal used for each container ofsupplied materials?8.11Does the company use a First-In-First-Out orFirst-Expiration-First-Out system?8.12Does the company maintain appropriate storageconditions?8.12aAre those storage conditions monitored anddocumented?8.13Does the site make available a description ofstorage and/or warehouse conditions?8.14Does the site distribute products via a third party?8.15Are good distribution policies implemented?8.16Are transport mechanisms dedicated?8.17Does the company validate shipping method?8.18Does the company validate packaging methods?Additional Comments:YesN/A for this SiteNoNot ApplicableI (Supplier) confirm that the information provided in this questionnaire is correct and can beverified.Date:22-FEB-2021Title:LS-QMD Visalia DistributionVisalia Site Self-Assessment version 1.012 of 12
active member of the Rx 360 Consortium. This document is based on the Rx-360 Consortium’s Supplier Assessment Questionnaire template, Module 2. The contents of this questionnaire are built on the Rx-360 questionnaire version 2.0 intact with no question added or deleted. Rx-360's CEO/COO gave permission to Life Science to use the Rx-360 logo.
self-respect, self-acceptance, self-control, self-doubt, self-deception, self-confidence, self-trust, bargaining with oneself, being one's own worst enemy, and self-denial, for example, are thought to be deeply human possibilities, yet there is no clear agreement about who or what forms the terms between which these relations hold.
2. Self-assessment 2 Metacognition and self-regulation 2 Self-assessment of competence 4 Self-assessment accuracy 4 Self-assessment of driver competence 5 3. Assessing perceived competence 8 Constructs of perceived competence 8 A construct for perceived driver competence 9 Instrument development 10 4. Validity theory 12
QAPI Self-Assessment Tool In order to establish a robust QAPI program in your organization it is important to conduct a self-assessment CMS QAPI At a Glance: Self-Assessment Tool found in Appendix A 3/16/2022 18 Discussion Q's Have you conducted a QAPI self assessment for your nursing home? What did you identify as an area to focus on?
3.6 Sexual Shame and Self-esteem; Self-esteem expert Rosenberg (1965) defined self-esteem as an attitude towards one's self, a self-worth with levels of positive and/or negative feelings about the self. Coopersmith (1967) described self-esteem as being an appreciation of oneself and showing self-respect,
associated with higher level osf self-handicapping i n young people. Moreover, certainty of self-esteem and the trait of self-handicapping wer noe t associated with self-handicapping. Stud 6 explorey d the relationship between self-esteem and self-handicapping using domain-specific measure of self-esteems an, d task specific self-efficacy.
Chapter 8 Site Survey and RF Design Validation Performing a Post Site Survey Assessment Performing a Post Site Survey Assessment The need for a wireless site survey is different in every situation. Performing a post assessment of the environment is very similar to a pre-site survey. There are particular guidelines and criteria that need to be met.
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Recommendation: Encourage continuous self-management program for children experiencing juvenile rheumatoid arthritis to improve quality of life, self-efficacy and thus reduce negative consequences of the disease. Key wards: Self-management program, self-efficacy, quality of life, juvenile rheumatoid arthritis and school age Children.
