1 Canadian Blood Services Societe canadienne du sang CBS Control #: CBS5590 HPFB Fi le #: C1? REF: H-1213-BRP 1800 Alta Vista Ottawa, ON K1 G 4J5 T F Mr. Richard Kirchner Supervisor, BTOX / GCP Un it Inspectorate Program, Ontario Region Health Canada 180 Queen Street W est, 10th Floo r Toronto, ON M5V 3L7 Dear Mr. Kirchn er: Re: Responses to Health Canada Inspection of Brampton Production and Distribution Centre to The following are th e acti ons undertaken by th e Ca nad ian Blood Services in response to the observations co nta ined in the Health Canada Exit Notice. Manufacturing control I Centrale de la fabrication - C Immediate actions were not carried out for a recall required under Non-Conformance Report (NCR) The date discovered for the issue was and the action noted under "Section 2: Immediate Actions" was "015 recall LB# ". However, the associated Component Retrieval Record (CRR) was not completed until This is contrary to step of SOP , Non-Conformance - Immediate Actions, Revision 2. Th e Product and Hospital Service staff member received refresher training to SOP , Non Conformance - Immediate Actions on Non-Conform ance was initiated on capturing th e details of this event. Manufacturing control I Centrale de la fabrication - C The following deficiencies were noted for documents re lated to NCR : a) The "Donated in Hema-Quebec" section was noted as "N/A" in the related Post Donation Deferral Form (PDDF). However, according to the related Record of Donation (Donation No. C ), the "Donor's Clinic of last attendance" was "HO" under the Registration Information Section.
2 Canadian Blood Services Non-Conformance was initiated on The importance of accurate documentation was reviewed with the involved staff member. In addition, refresher training to , Assessment of Hema-Quebec Donation History and SOP , Managing Recalls with PROGESA was completed on A corrected PDDF was attached to the original PDDF. The risk was assessed as minimal as the appropriate actions were carried out at the time. b) There was information missing on the corresponding PDDF form related to the donor's address, telephone#, and Clinic Attended. This is contrary to step 1.2 of the SOP , Information Received Post Donation, Revision 10. Non-Conformance was initiated on Feedback was provided to the involved staff member stressing the importance of Good Documentation Practices. In addition, refresher training to SOP , Information Received Post Donation, version 10, was completed on A corrected PDDF was attached to th e original PDDF. c) The "Reason for Recali/Withdrawal" in the related "Notification of Component RecalllWithdrawal" document was documented as "Other". However, it was confirmed that it should have been noted as "Incomplete Documentation on the Record of Donation." Non-Conformance was initiated on This documentation discrepancy was discussed with staff on Manufacturing control / Contrale de la fabrication - C The following deficiencies were noted for documents related to NCR : a) The Collection/Pooling Date for DNLlPNL No. C S under "Section 8: Product listing for Reportable Events" for this NCR was noted as However, the related "Notification of Component RecalllWithdrawal" record noted the Collection Date as " ". This is contrary to step of SOP , Managing Recalls with Progesa, Revision 8. Non-Conformance was initiated on Please note that the collection date of does not appear in our re cords. According to the Notification of Component Recall! Withdrawal record referred to in this observation, th e collection date of was documented on the Notification of Component RecalllWithdrawal record, rather th an the pooling date of , as required. The documentation discrepancy and the in structions in SOP , Managing Recalls with PROGESA, Step was reviewed with the employee involved on Furthermore, Medical Laboratory Technologists, Senior Technologists and Charge Technologists were asked to review with staff SOP 08772, Step , by to ensure that it is understood th at "collection date" for pooled platelets reflects th e pooling date when completing the Notification of Component RecalllWithdrawals form. b) There was information missing on the corresponding PDDF form related to the donor's address, telephone#, Clinic Attended, and Clinic Date. This is contrary to step 1.2 of the SOP , Information Received Post Donation, Revision 10.
3 Canadian Blood Services Non-Conformance was initiated on Feedback was provided to the involved staff member stressing the importance of Good Documentation Practices, In addition, refresher training to SOP , Information Received Post Donation, version 10 was completed on A corrected PDDF has been attached to original PDDF. Manufacturing control I Contro Ie de la fabrication - C Several NCRs were not completed in a consistent manner. For example: There were inconsistencies between the "Date discovered" and "Date occurred" categories under "Section 1: Non-Conformance Details" for NCR's , , and Canadian Blood Services agrees that there are some issues with the consistency in which non-conformance report forms are being completed. This issue with non-conformance records will be added to the items to be discussed in face-to-face meetings with Quality Assurance staff and members of management at all locations in Southern and Central Ontario by the Executive Director, Quality System Support as part of the implementation activities for the Standardized Deviation Management Process Ph ase 2 (SDMP-P2) initiative. These discussions will be completed prior to Brampton implementation of SDMP-P2, currently scheduled for In addition, a particular focus will be placed on assessing the quality of the non-conformance records as part of the SDMP-P2 post implementation monitoring and assessment work, currently scheduled to be completed by , in order to determine if additional actions are needed to improve on the quality of these records. Manufacturing control I Controle de la fabrication - C During Lot acceptance of RadSure labels received on November 29/2012, initials were not recorded on the corresponding Irradiation Indicator Shipment Acceptance form. This is contrary to step of SOP , Lot Acceptance of Irradiation Indicators, Revision 5. Our investigation confirmed that the Irradiation Indicator Shipment Acceptance form was implemented on The correct version ofthe Irradiator Indicator Shipment Acceptance form (IISA)was used at the time of receipt ofthe RadSure labels on and SOP , Lot Acceptance of Irradiation Indicators, version 4 was followed. The revised version ofthe lisa form was implemented with SOP , version 5, on Manufacturing control I Controle de la fabrication - C NCR was initiated for the receipt of Rad-Sure labels with Lot number U15. The non-conformance was reported as"... the Distribution department did not include a "Logistics Shipment Acceptance Stamp" on the packing slip... " However, it could not be determined whether this stamp was actually required. The work instructions in section 3 and 4 of SOP , Receiving Inventory-CBS Sites, Revision 4, were not clear in describing the steps required to receive labels, which are transferred to the user department, undergo lot acceptance, and are then approved for release by QA. Furthermore, Irradiation Indicator Labels were not included in Supplement v.01, approved on
4 Canadian Blood Services Our in vestigation confirmed that the current procedure (SOP , Receiving Inventory-CBS Sites, version 4, Step 1.6.2) was followed. RadSure labels are a non-inventory item and the use of the Shipment Assessment Stamp is not required until after the delivery is made to the department. There is currently a working group reviewing SOP This information will be provided for consideration as part of their review. Manufacturing control! Contr61e de la fabrication - C Step of SOP 12203, Receiving Inventory - CBS Sites, Revision 4, states "Obtain Proof of delivery, if applicable". During the inspection, it was confirmed that this step is not optional and that proof of delivery should be obtained for the delivery of all noninventory supplies. This was not done for the delivery of RadSure labels with lot number U15. The requirement was discussed with warehouse staff on to ensure that proof of delivery is obtained for the delivery of all non-inventory supplies including RadSure labels, in accordance with Step of SOP , Receiving Inventory - CBS Sites, version 4. Manufacturing control! Contr61e de la fabrication - C Despite retraining between and , procedures were not followed for SOPs associated with receiving supplies, including SOP Receiving Inventory - CBS Sites, Revision 4; SOP , Shipment Acceptance of Blood Packs, Revision 3.0, SOP , Acceptance of Critical Supplies, Revision 3.0. Examples of supplies not received as required by these SOPs include: Fenwal Optipure blood packs with lot no. 12G12L01; Vacutainer Tubes with lot no ; and Vacutainer Tubes with lot no A new Center Operating Procedure, COP v. 01 was developed and implemented on to facilitate which SOPs to follow pertaining to material received. The documentation that was reviewed preempted the implementation of this COP. We will verify documentation since implementation of COP v.01 to assess if refresher training is required. Manufacturing control! Contr61e de la fabrication - C In the response letter to Health Canada dated , CBS Control # CBS5502, the foliowing statement was made: "Assessment and improvements to SOP 12203, Receiving Inventory - CBS Sites (Observation 7 and 19). This will take six to nine months. In the interim, a Directive will be implemented by clarifying current practices." However, a Directive was not implemented.
5 Canadian Blood Services Following our initial response on , it was determined that the instructions in SOP Section 2 actually indicate clearly how to record the temperature monitoring device information upon receipt of Plasma Protein Products. It was decided that training could address the observations appropriately and that a Directive dealing with issues raised in Observation 7 and 19f was not necessary. The intent of Directive , Update Documentation Requirements for Receipt of Goods was written and implemented on in response to previous Health Canada audit observations (i. e. observation #3 from Ottawa - Concourse Gate, and observations 19b, 19d and 24 from Brampton. Manufacturing control I Contr61e de la fabrication - C There was no definition for "Date Discovered" in the Non-Conformance Report Job Aid, V Canadian Blood Services agrees that there is no formal definition for "Date Discovered" in the Non-Conformance Report Job Aid , nor is this term defined or specific guidance given in any other non-conformance process related documentation. While the absence of a definition for this term and the potential that this may contribute to variation amongst staff in the date they record on the non-conformance report form for 'Date Discovered' is recognized, variation in the date recorded does not have any impact on product quality or necessary actions taken at the time of the non-conformance. It is recognized, however, that variation in the 'Date Discovered' recorded on the non-conformance report form can cause confusion in the assessment of the history of actions taken in response to the identification of a nonconformance based on the non-conformance record. In particular, variation in the 'Date Discovered' can make it difficult to ascertain from the non-conformance record that all required actions, including quarantine/recall of suspect product and reporting to regulatory authorities where required, were completed in a timely manner upon discovery of the non-conformance. This deficiency in process documentation will be addressed only after the completion of the Standardized Deviation Management Process Phase 2 (SDMP-P2) initiative roll-out to all Canadian Blood Services locations currently in progress (Brampton implementation scheduled for ). This issue will be added to the SDMP-P2 post implementation monitoring and assessment work already underway, and will be prioritized for addressing with all other issues identified based on risk. Personnel I Personnel - C Several "Validation of Skills Records" (VSR) were not being completed as required by the "Training Practices Guide, Part 4 - Validation Skills", Some examples are as follows: a) The "Observer Signature", "Date", and "Manager Notified" sections were not completed for the following training records: CA and Phlebotomist, training completed on ; RN, training completed on ; RN, training completed on Non-Conformance was initiated on Our investigation revealed that some of the trainers did not have a clear understanding of instructions for completing Validation of Skills Record. Feedback was provided to staff involved and refresher training to the Training Practices Guide, Part 4, Validation Skills was completed by
6 Canadian Blood Services b) Although the VSR for an RN, training completed on , indicated an "Unsatisfactory" Assessment for SOP , Perform Health Interview, the "M anager Review - Action on Recommendations, "Manager Signature" and "Date" sections were not completed. Non-Conformance was initiated on During the validation of skills assessment held on , the trainer's assessment for SOP , Perform Health Interview determined the staff member's skill level to be satisfactory. However, the written test which was marked on indicated an unsatisfactory result. The trainer met with responsible staff on to review the Validation of Skills Record. At that time, the trainer noted acceptable demonstration of knowledge. The staff member was assessed as satisfactory. The Validation of Skills Record was then completed and signed off by the Manager. Refresher training to the Training Practices Guide, Part 4, Validation of Skills was completed by the Manager on Personnel I Personnel - C The "Regional Manager Field" and the "Manager Supply Services" were trained to SOP , Receiving Inventory - CBS Sites, Revision 4 on March 4, However, this revision of the SOP was not approved until April 11, This was determined to be a documentation discrepancy. Our investigation confirmed that the Regional Field Manager and the Manager of Supply Services were trained to SOP , version 4 on and not on as re corded. ( please refer to observation 2 1). Personnel I Personnel - C The Assistant Quality Assurance Manager position was not listed on the Quality Assurance Brampton Site Training Matrix. During the inspection, it was confirmed that this is a separate position that may have unique training requirements. The Assistant Manager, Quality Assurance position is considered a designate for the Quality Assurance Manager. Although this position title was not identified on the local Quality Assurance training matrix, the Assistant Manager was trained to all required procedures. A review of the Brampton Quality Assurance training matrix identified that the Assistant Manager, Document Control was also missing on the local matrix. Both Assistant Manager positions were added to the local matrix and the matrix was approved on In addition, the Head Office standardized Quality Assurance training matrix was revised on to include the training requirements for both the Assistant Manager, Quality Assurance and Assistant Manager, Document Control positions. Th e Brampton Quality Assurance training matrix now aligns with the Head Office standardized Quality Assurance training matrix. Personnel I Personnel - C SOP 12203, was identified as required training for Brampton Quality Assurance Staff. The Assistant Quality Manager had not yet completed training to this SOP.
7 Canadian Blood Services Non-conformance was initiated on Training ofthe Assistant Manager, Quality Assurance and the Quality Assurance Manager was completed on and respectively. As per Directive , version 2, a review ofthe required QA training and supporting documentation was completed by It was confirmed that all other staff who performed the release of critical supplies were trained to SOP Receiving Inventory, on No other gaps were identified. Personnel / Personnel - C SOP , Inspection/Preventive Maintenance of Sorvall Centrifuges was not listed on the Brampton Laboratory Training Matrix. However, it was confirmed that Laboratory personnel are responsible for performing Steps 1.5 and 1.6 of this SOP. Non-Conformance was initiated on Steps 1.5 and 1.6 were added to the Production Training Matrix on In addition, all Medical Laboratory Technologists, Senior Technologists and the Charge Technologist have completed th e review of SOP Steps 1.5 and 1.6. Personnel / Personnel - C For several observations noted during the inspection conducted between and , the corrective actions undertaken were listed as staff meetings, staff huddles, minutes sent to staff and s sent to staff. However, it could not be determined which staff attended the meetings or reviewed the notifications as attendance/staff review was not documented. For example: An informal staff meeting held to review SOP by Biomed in response to observations 12b and 14b; Production Huddle minutes for in response to observation 12; to Distribution Staff sent on in response to observation 40; and Production Huddle minutes for in response to observation 39. Starting , an attendance record will be used to capture staff attendance at meeting and huddles, and a subsequent "read and sign" will occur for those staff not in attendance. Equipment / Equipement - C The following deficiencies were noted on NDAS records: a) The NDAS Alarm History Review Log for November 2012 (Component Production) was not filled out according to SOP , NDAS Site Operation, Revision 5. Although, BRM 1076 went out of range on Nov 19, 2012, there was no alarm noted or SQuiPP assessment conducted for this excursion on the corresponding Alarm History Review Log. Despite re-training as part of the corrective actions to similar observations made during the May 2012 inspection, the related procedure was not followed.
8 Canadian Blood Services Non-Conformance was initiated on Assignment of NDAS Alarm History Log completion was added to the posted task list for Production in late October SOP requirements for the NDAS Alarm History Review was reinforced at the Medical Laboratory Technologist/Senior Medical Laboratory Technologist meeting on In addition, effective , a check box for completion of NDAS Alarm History Review Log will be placed on the daily Shift Update tool. Staff will document that the Alarm History Review Log was completed on their shift. b) BRM 1092 went out of range several times in November However, there were no notations on the corresponding trend log and SQuiPP assessments were not conducted for these excursions. This was contrary to SOP , NDAS Site Operation, Revision 5. The frequency with which the temperature will briefly go out of range is due to the opening of the freezer door during loading of conditioned ice packs. Ice packs are conditioned prior to loading them into BRM 1092 storage freezer. The freezer alarm is triggered due to the sensitivity and set points of the alarm. Feedback was provided to Distribution staff on to remind them of the required SQulPP assessment including notations associated with temperature excursions. Equipment I Equipement - C The November 2012 (Distribution) NDAS Alarm History Review Log were not available for review, contrary to SOP 13009, NDAS Site Operation, Revision 5. Despite retraining as part of the corrective actions to similar observations made during the May 2012 inspection, the related procedure was not followed. Non-Conformance was initiated on Daily reviews did not occur for the time period to , and the NDAS Alarm History Review Logs were not completed as per SOP for to When these omissions were noted on during supervisory review, a retroactive review was completed for the NDAS points. It was assessed th at the excursions had no impact on SQuIPP. Following our review of NDAS Site Operation with staff, to clarify responsibility of completing the daily NDAS Alarm History Review Log was assigned to the day shift. Equipment I Equipement - C The NDAS trend log reports were not consistently run in November 2012 for BRM 1066, 1065, and 1064, related to equipment shared between Component Production and Distribution. For example: The NDAS trend log for BRM 1066 was not completed between Nov 20-27,2012. Additionally, the NDAS Point-Production record for Nov 27, 2012 noted these three probes as "N/A". NDAS Site Change Request was submitted on to assign ownership of probes BRM 1064, BRM 1065 and BRM 1066 to Product Distribution staff to clarify the responsibility for running trend logs and to ensure that this activity is conducted consistently.
9 Canadian Blood Services Equipment I Equipement - C NDAS points BRM 1022 and 1031 were noted as being "out of service" on the NDAS Trend Logs run between Nov 10 and Nov 20,2012 for BRM 1021 and 1030, respectively. The same NDAS points were also noted as being "out of service" on the NDAS Points - Production record for Nov 27, However, it was confirmed that these probes were never implemented. The original specifications for th e number of NDA S points included points 1022 and as secondary points in two separate small areas. Prior to moving into the Brampton Site, th e User Department determined th at th ese secondary points were not required. Primary NDA S probes have been in use since the Brampton Site go-live. A NDA S Site Change Request was initiated to remove points 1022 and This is targeted for completion by Records I Dossiers - C The Supply Services Confirmation of Employee Training form for training on SOP , Receiving Inventory - CBS Sites, Revision 4, listed the document number as COP and the. version as 5. Our investigation confirmed that th e staff were trained to SOP , version 4, in May however the Confirmation of Employee Training (CET) record contained incorrect information. A corrected CET was initiated and all affected staff were retrained to SOP , version 4, in August If you require clarification or further information, please do not hesitate to contact the undersigned. Please refer to the above control number in all correspondence. Sincerely, (. C LLo ti..eu.-g etr~ f- Or. Christian Choquet Vice-President Quality & Regulatory Affairs Fax Number:
Canadian Blood Services Societe canadienne du sang 1800 Alta Vista Ottawa, ON K1 G 4J5 T 613.739.2300 F 613.731.1411 www.blood.ca www.sang.ca 2013-03-18 CBS Control #: CBS5613 HPFB File #: C1892-1 00390
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials
Far West Technology, Inc. ISO 9001 Quality Manual Document No.: QM Revision: 0 Issue Date: 27 August 1997 Approval Signatures President/CEO Executive Vice President Vice President/CFO Change Record Rev
Edwin Lindsay Principal Consultant, Tel: + 44 (0) 7917134922 E-Mail: email@example.com Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes
Site visit inspection report on compliance with HTA minimum standards London School of Hygiene & Tropical Medicine HTA licensing number 12066 Licensed under the Human Tissue Act 2004 for the storage of
Cellular Therapy Liaison Meeting 10 September 2009 BECS M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB Definition from October 2007 draft guidance BECS Validation In the User s Facility
Quality Management System Manual This manual has been reviewed and approved for use by: Jack Zazulak President, Aurora Machine Limited March 07, 2011 Date - Copyright Notice - This document is the exclusive
4.0 Receiving Process Delivery of requested products or services marks a transition in the Purchase-to-Pay process from a purchasing activity to a payables activity. All purchases must be received to release
QEP PROGRAM PARTICIPANT BRIEFING Document information and distribution Author: Rev. and appr. by: Chris Fore, Compliance Manager Bourji Mourad, Head of Global Partner Management & Compliance Date: July
NIST HANDBOOK 150-5 CHECKLIST CONSTRUCTION MATERIALS TESTING Instructions to the Assessor: This checklist addresses specific accreditation criteria prescribed in NIST Handbook 150-5, Construction Materials
Page 1 Company Name: Date of audit: Date of last audit performed: Name of person performing self-audit: Signature: Name of person responsible for quality system: Signature: Number of non-compliances: Page
A Guide to Pharmacy Documentation For Clinical Trials Roy Sinclair Clinical Trials Pharmacist St. George s Hospital (to Sep 2007) Lecturer Kingston University January 2008 A Guide to Pharmacy Documentation
Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person:
INTRODUCTION This document describes an inspection system broken down into four separate levels. When Inspection Level IV is invoked, this system meets the requirements of former MIL-I-45208A. The primary
Internal Audit Audit of the Inventory Control Framework June 2010 Table of Contents EXECUTIVE SUMMARY...4 1. INTRODUCTION...7 1.1 BACKGROUND...7 1.2 OBJECTIVES...7 1.3 SCOPE OF THE AUDIT...7 1.4 METHODOLOGY...8
ALABAMA RESEARCH & DEVELOPMENT This complies with the Requirements of ISO 9001:2008. Prepared By: Phyllis Olsen Release Date: 03/19/09 Quality Policy & Objectives s quality policy is to achieve sustained,
MAIL-IN / ONSITE This report is intended to furnish data relative to the Suppliers capability to control the quality of supplies and services furnished to Ontic UK. Please complete this Survey and return
5th Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration Summary of Changes This document summarizes the changes made to the 5th edition of the
This complies with the Requirements of ISO 9001:2008 and ISO/IEC 80079-34, Explosive Atmospheres - Edition 1.0 2011-04 Prepared By: Phyllis Olsen Release Date: 10/28/15 Certificate No: CERT-08776-2006-AQ-HOU-RvA
1 of 5 1. Scope 1.1. This work instruction provides specific direction for qualifying vendors as required in SOP-5, Purchasing Components. 2. Definitions and Acronyms 2.1. Definitions for terms used in
CLOVER MACHINE AND MFG. 800 MATHEW ST. #101 SANTA CLARA, CA 95050 727-3380 727-7015 fax REVISION: DATE: PAGE 1 OF 45 QUALITY POLICY MANUAL DISTRIBUTION LIST: President Purchasing Manager Vice President
Section 5 510(k) Summary (in accordance with 21 CFR 807.92) Date: December 19, 2013 Submitter: Haemonetics Corporation Software Solutions 4925 Robert J Mathews Pkwy., Suite 100 El Dorado Hills, CA 95762,
10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular
EMS Example Example EMS Audit Procedure EMS Audit Procedures must be developed and documented with goals which: Ensure that the procedures incorporated into the EMS are being followed; Determine if the
Bridge Inspection Handbook 5-1 CHAPTER 5 QUALITY CONTROL AND QUALITY ASSURANCE 5.1 QUALITY CONTROL and QUALITY ASSURANCE are integrated into all aspects of bridge inspection. They contain the essential
Page 1 of 7 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2014 Inspections, Compliance, Enforcement, and Criminal Investigations
Audit of IT Asset Management Report Recommended by the Departmental Audit Committee for approval by the President on Approved by the President on September 4, 2012 e-doc : 3854899 1 Table of Contents EXECUTIVE
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
ACCREDITATION OF OWNER/USER SELF-INSPECTION REPAIR PROGRAM TSSA GUIDE FOR REVIEW TEAMS The Technical Standards and Safety Authority Boilers and Pressure Vessels Safety Division 3300 Bloor Street West 14th
*Changes from the previous QASE noted by "yellow" highlight of block Evaluation Summary Company: Prepared By: Section Element Manual Audit OK Objective Evidence 2.1 Objective of Quality Assurance Program
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program Part 2 GCP Information Sessions November 2010 Inspection Program Main objectives
Quality Management Plan Procedure Check the Capital Project Delivery website to ensure this is the current version. Table of Contents Quality Management Plan Overview... 1 Introduction... 1 Objectives...
This Page 1 of 35 of the Quality Management System Manual If issued as a controlled copy, the serial number of this copy is Quality Management System Manual Certified to AS9100 Revision C Printed copies
Procedure for Conducting Audits and Management Reviews 1.0 Purpose This procedure establishes the method by which Quality System audits and management reviews are performed within the State Crime Laboratory
EFI ACCREDITATION PROGRA INSTRUCTIONS TO APPLICANT - PACKET A and C: APPLICATION FOR ACCREDITATION AND RENEWAL OF ACCREDITATION Please read all instructions carefully and review the enclosed EFI standards
3.1.2 3.1.1 Introduction OH&S Management Systems Audit Checklist (NAT, E3) This audit checklist is based on Element 3 (Implementation) of the National Self-Insurers OHS Audit Tool. For a full copy of the
Page 1 of 8 1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System 2. Application This Standard Operating Procedure applied to the entire Quality Management System as it relevant
ATTACHMENT COMPARISON OF APPENDIX B TO ISO 9001-2000 CRITERION I: ORGANIZATION 10 CFR 50 APPENDIX B ISO 9001-2000 REGULATORY IMPACT/COMPLIANCE I - Responsibility for establishing and executing of a quality
Clinical Site Monitoring Walt Jones RN, MPH Nurse Consultant Clinical Monitoring Coordinator OCRA, DMID, NIAID November 1, 2007 Clinical Monitoring Contractor Contracted to PPD from Wilmington, North Carolina
Procedure for Procurement and Receipt 1.0 Purpose - To ensure that all supplies, equipment and services purchased by the State Crime Laboratory (Laboratory) are properly procured and received. 2.0 Scope
June 8, 2011 NOTICE Our file number: 11-110913-528 Re: GD211: Guidance on the Content of Quality Management System audit reports Health Canada is pleased to announce the release of the guidance document
Version 6.0 FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing, Documenting, Implementing, Maintaining and Auditing the Program (Edition 6.0) PREFACE FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing,
Chapter 10 Receiving, Inspection, Acceptance Testing and Acceptance or Rejection Table of Contents Receiving, Inspection, Acceptance Testing and Acceptance or Rejection...1 Chapter 10...3 Receiving, Inspection,
FCIA Education Program Quality Module UL Qualified Contractor Firm Candidates Management System & Audit Preparation Education FCIA July 8, 2007; November 2007; March 2008 FCIA Management System Education
Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205 www.schweppesaustralia.com.au Quality Management Systems 1. Quality Management Systems develop, implement, verify
PAGE 1 OF 40 QUALITY Note: The revision level of this document and any referenced documents must be verified for latest issue before use QOP-00-02 TITLE QUALITY ASSURANCE SYSTEM MANUAL APPROVALS DATE REVISIONS
I. PURPOSE This manual is to assist our supply base in understanding our ongoing needs and requirements. A current revision is posted at http://www.nittousa.com/files/suppliers.aspx for review by our raw
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health
QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. Hattiesburg, MS Revision E 01/19/11 Revised to ISO 9001:2008 on July 9, 2009 JPM OF MISSISSIPPI, INC. MANAGEMENT QUALITY POLICY It is the goal of JPM of
Internal Audit Checklist 4.2 Policy Verify required elements Verify management commitment Verify available to the public Verify implementation by tracing links back to policy statement Check review/revisions
1. QUALITY MANAGEMENT SYSTEM QUALITY MANAGEMENT SYSTEM (QMS) ASSESSMENT CHECKLIST 1.1 Quality Management System General 1.1.1 Is objective evidence available to demonstrate that the MDSAP site has defined,
Guide to Quality System for General Sale Wholesale Distributors IA-G0038-2 1 NOVEMBER 2013 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.
Site visit inspection report on compliance with HTA minimum standards Belfast Cord Blood Bank HTA licensing number 11077 Licensed for the procurement, processing, testing, storage, distribution and import/export
Page 1 of 14 T38 PROGRAM FLOW DOWN REQUIREMENTS T38 Program - Flow down Requirements accompanied with IAI General Terms and Conditions clauses are the terms and condition applicable to this Program. Unless
GENERALLY ACCEPTED ACCOUNTING PRINCIPLES GRFS 2 - Payroll Preliminary standard dated 15 August 2006, prepared by the Norwegian Association of Authorized Accountants (NARF) and Økonomiforbundet (the Finance
CHAPTER 7 QUALITY ASSESSMENT Chapter 7 QUALITY ASSESSMENT 7.1 OVERVIEW OF CBB-SPECIFIC QUALITY ASSURANCE/QUALITY CONTROL PROGRAM An extensive, site-specific Quality Assurance/Quality Control (QA/QC) program
MODEL FINAL VERSION 1, MARCH 2003 ACKNOWLEDGMENTS This Manual is based on Environment Australia s Model EMS 1 and has been adapted for use by Victorian Government agencies by Richard Oliver International.
Aboriginal Affairs and Northern Development Canada Internal Audit Report Audit of Water and Wastewater Infrastructure Prepared by: Audit and Assurance Services Branch Project # 12-10 February 2013 TABLE
Dutch Accreditation Council (RvA) Policy rule Nonconformities and Corrective action Document code: RvA-BR004-UK Version 2, 23-1-2015 RvA policy guidelines describe the RvA rules and the policy on specific
FINAL REPORT FOR CITY OF STOCKTON INTERNAL AUDIT OF PAYROLL OPERATIONS April 4, 2014 Prepared by: Moss Adams LLP 3121 West March Lane Suite 100 Stockton, CA 95219 (209) 955 6100 TABLE OF CONTENTS I. EXECUTIVE
1.0 SCOPE CQR-1 CONTRACTOR QUALITY REQUIREMENTS for CONSTRUCTION SERVICES This document establishes the minimum quality program requirements for a contractor providing equipment, material, and construction
Canadian Grain Commission Certification of an Identity Preserved and/or HACCP-Based Food Safety Program (CIPRS, CIPRS+HACCP, CGC HACCP) CGC QSP 1.1.0 Uncontrolled Copy Canadian Grain Commission Process
SPECIAL INSPECTION & TESTING AGREEMENT CITY OF NOVI BUILDING DIVISION Michigan Building Code 2012 (MBC 2012) Project Name: Project Address: Building Permit No.: PRIOR TO THE ISSUANCE OF THE BUILDING PERMIT:
Hiring Process Guide Form names which are bolded can be found on the Liaison Resources page (http://www.tamhsc.edu/payroll-hr/liaisons.html). This document is provided to assist hiring managers through
Registrars Independent third parties who assess an organization s Quality Management System Not controlled by ISO US registrars have no government sanction Private companies performing their service for
ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:
Auditor General s Office Governance and Management of City Computer Software Needs Improvement Transmittal Report Audit Report Management s Response Jeffrey Griffiths, C.A., C.F.E Auditor General, City
Nurse-Managed Medication Inventory Information for Employers College of Registered Nurses of British Columbia 2855 Arbutus Street Vancouver, BC Canada V6J 3Y8 T: 604.736.7331 F: 604.738.2272 Toll-free:
Quality Control Procedures QCP 5.3 Page 1 of 5 1.0 PURPOSE RECEIVING INSPECTION PROCEDURE To establish a uniform method for the control and inspection of purchased items. 2.0 SCOPE This procedure applies
Audit Report AS/NZS ISO 9001:2008 RRW and Co Pty Ltd trading as National On Site Training AUDIT D E T A I L S Invoice Reference Number Certificate Number Review Date/s Review Time Hours S12627 158 10 th
GUIDELINE Professional Engineers Using Software-Based Engineering Tools CONTRIBUTORS Eric Brown, P. Eng. Colin Cantlie, P. Eng. Norm Fisher, P. Eng. Jeremy Jackson, P. Eng. Tibor Palinko, P. Eng. Daniel
Idaho Department of Correction Stard Operating Procedure Control Number: 1 of 16 Adopted: 5-20-2011 Reviewed: 6-8-2011 Next Review: 6-8-2013 Management Division General Administration Management: Healthcare
CONFORMED COPY Method Statement Revision History Revision Date Reviewer Status 23 March 2007 Project Co Final Version 1 Table of Contents 1 Objectives... 3 2 Management Supervision and Organisation Structure...
Health Information and Quality Authority Regulation Directorate Compliance Monitoring Inspection report Designated Centres under Health Act 2007, as amended Centre name: Centre ID: Cahermoyle House Nursing
Your consent to our cookies if you continue to use this website.