DOCUMENT REVISION HISTORY PAGE - dmetraindocuments.dmetrain.com/custom/1542/courses/Z90a... · DOCUMENT REVISION HISTORY PAGE Document Number: Rev: ... in sections 7.4, 7.6.1,

DOCUMENT REVISION HISTORY PAGE

Document Number: Rev: Page:

90A0001 AK 2 of 25 Title: Documentation Control

Revision History Of Document

Rev

CO

Number

Description of Change

Author

Effective Date

FI --- First Issue (on Y01-8001) N/A 7/11/89

A 5 Add Req. Doc. To Level 2; typos (on Y01-8001) NRO 8/16/89

B 43 Revision of document to reflect change in LIFECOR part GEM 12/31/91 number system. Previous document number was Y01-8001.

C 193 Changed document from WordPerfect to Word for Windows. NTO 12/2/94 Edited existing information to improve readability. Detailed the responsibilities of Documentation Control.

D 247 Document correction: the responsibility for assigning P/M NTO 8/10/95 numbers belongs to Component Engineering, not Doc. Control The responsibility for assigning software and software documentation numbers belongs to the Software group, not Doc. Control. Also clarified documentation database operation. Removed some sign-off names from front cover to reflect the current applicable signatures required.

E 627 Added option of submitting and storing files electronically. G.P. 2/18/98 Revised Approval Pages 90A0001-A01 and A02 to provide for electronic file information. Added new 90A0001-A03 Revision History Page. Added requirements for Documentation Database and maintenance of read-only directory for all employees. Established format for electronic files. Added provision for determining and indicating level of review and approval for documents. Added requirement for a distribution list for controlled documents. Deleted redundant definitions. Added section 5 “Creating a Controlled Document”. Deleted references to 90A0024 SOP for Releasing New Documentation.

F 648 Added examples of filenames for BOMs, drawings, and GP 3/27/98 production routings. Deleted “reports” from matrix in section 6.0 and replaced with “protocols”. Added “Eng” to “Test Plans, Procedures, and Protocols”.

G 704 Added Section 12 describing how external documents (IEC, GP 9/1/98 ISO standards, etc.) are handled. Revised Approval Pages to include a check box indicating if the document is part of a Technical File required by the Medical Device Directive. Added a new Approval Page 90A0001-A04 for (cont. on next page)

ZOLL Form Number: 90A0001-A03

Form REV Level: J





Rev

CO

Number


Author

Effective Date

G 704 documents requiring Executive Management approval. (cont.) (cont.) Revised Approval Signature blocks on 90A0001-A01 and

revised the review and approval matrix in Section 6. Revised section 8.2.1 to address the conversion of hardcopy documents to electronic format for Technical Files, etc.

H 738 See change Order. GEM 11/6/98

J 762 Revised section 9.2 to address electronic file name format GP 1/28/99 for Protel generated hierarchical files.

K 1080 Clarified Executive Management approval signatures in GP 9/29/00 approval matrix. Revised Executive Management Approval Page 90A0001-A04 accordingly. Clarified signature authority in section 7.

M 1119 Revised approval matrix in section 7 to specify the GP 12/15/00 managerial level of individuals authorized to approved documents. Updated forms A01 through A04 to Rev F to reduce confusion on proper form revisions. Made minor formatting corrections. Revised “Introduction” and added “Scope” to more closely reflect FDA & ISO definitions.

N 1258 Added section 11.4 “New Revision Distribution and Obsolete S.D.Q. 05-09-01 Document Recall” and 90A0001-A05 “Document Distribution Control Form”.

R 1550 Added Design & Development Plan to Approval Matrix. GP 12-18-02 Removed Table of Contents. Added Process Validation Plans, Procedures, Protocols to Approval Matrix. Revised forms 90A0001-A01 & 90A0001-A02 to add checkbox for Tech File CDROM. Changed “Clinical Research” to “Medical Affairs” in Approval Matrix and forms 90A0001-A01 & 90A0001-A04. Updated Rev Levels of 90A0001-A03 and 90A0001-A05 to match revised forms.

S 1720 Added Marketing to approval matrix and approval pages. GP 03-01-03 Added advertising and marketing literature to approval matrix. Clarified section 7.7 regarding QSR, Tech File, etc. Revised forms 90A0001-A01 through A05 to “H”. Revised section 5.4 to include off-site storage. Corrected Exec Mgmt position titles in approval matrix.


Form REV Level: J





Rev

CO

Number


Author

Effective Date

T 1877 Clarified section 9.2 on database capabilities. Corrected typos GP 07-25-03 in sections 7.4, 7.6.1, and 7.9. Revised section 8 approval for Marketing and Advertising Literature.

U 1935 Replaced references to ISO 9001 with ISO 13485. Updated GP 04-01-04 Table 2 to reflect current Executive Management structure. Revised Executive Management Approval Page 90A0001-A04 to reflect current Executive Management structure.

V 1981 Added retention period for superceded and obsolete documents. GP 01-26-05

W 2162 Change signature authority page to match current KS 05-06-08 organizational structure

X 2759 Added clarification for Marketing and Advertising in 6.2.1 BL 02-26-10

Y 2617 Removed the 11th bullet of section 9.2 that required the VG 07-16-10 Documentation Database to identify whether a document is is maintained as an electronic file or a hard copy.

Z 3085 Replaced “Lifecor” with “ZOLL” for branding purposes. Changed ISO 9001 to ISO 13485 in sections 1 & 2. Added Clinical Ops, Mfg/Service, and Billing/Reimbursement to Table 1 as approvers. Added Patient/Physician Communications, Billing / Reimbursement Policies & Procedures, and Technology Applications Policies & Procedures to Table 1. Added VP Reimbursement to Table 2 as approver. Changed “Manager of Quality Assurance” to “QA/RA” in Tables 1 & 2. Removed VP Medical Affairs from approver for SOPs. Added Technology Applications to Tables 1 & 2 as approver. Revised 90A0001-A01 to Rev K by adding Mfg/Service, Billing/Reimbursement, Clinical Ops, and Technology Applications, changed Manager of Quality Assurance” to “QA/RA” and “Operations” to Mfg Eng” and removed Tech File CDROM check boxes. Revised 90A0001-A02 to Rev J by removing Tech File CDROM check boxes. Revised 90A0001-A03 & -A05 to Rev J by updating ZOLL branding. Revised 90A0001-A04 to Rev L by adding VP Reimbursement & changed Manager of Quality Assurance” to “QA/RA”.

GP 06-04-12

ZOLL Form Number: 90A0001-A03 Form REV Level: J





Rev

CO

Number


Author

Effective Date

AA 3282 Added Support Services Policies and Procedures to approval GP 04-02-13

matrix. Added Reconditioning and Service policies and procedures to approval matrix.

AB 3608 Added Manufactured (In-House) Product Drawings, BOM’s, & Specs to approval matrix.

CJM 06-17-14

AC 3612 Updates to reflect current business model. Section 6.2.1, added Labeling. Section 8, added statement that external customers may be included in an informal review and approval of documents. Table 1, removed Patient/Physician Communications, Billing and Reimbursement Policies and Procedures, and removed statement that Medical Affairs signature is required when D&D plan includes clinical testing. Table 2, removed VP Sales, VP Marketing, VP Medical Affairs, VP Reimbursement, and Support Service. Section 11.4, replaced employee with “individual or locations (if any).” Updated required signatures on 90A0001-A01 and 90A0001-A04 to reflect current business model. Updated ISO 13485:2003 to ISO 13485:2012 throughout.

LF 06-23-14

AD 3824 Updated required signatures on 90A0001-A01 and 90A0001-A04 to reflect current business model (removed VP Finance/Admin, HR, IT as these shared services are provided by the holding company effective Jan 1, 2015). Updated Table 1 and 2 to remove Finance/Admin and Tech Apps.

GP 02-23-15

AE 3703 Updated 90A0001-A01 to Rev N and 90A0001-A02 to Rev K to JK 09-29-15 Include checkbox for ‘Does the Release Of / Change of this Document require DMR update?’ to ensure update to Individual DMR’s when required. Author of document change Responsible for verifying linkage to the DMR and including/ Removing when applicable section 7.7.2.


Form REV Level: J





Rev

CO

Number


Author

Effective Date

AF 4110 Updated section 5.4 to clarify that documents may be stored

onsite or offsite. Updated 7.7.3 to state that RA shall determine if the document must be included in the Tech File file-sharing utility. Updated 7.11 to include RA signature for archival documents. Updated Form 90A0001-A01 to include checkbox for Tech File file-sharing utility. Updated Form 90A0001-A02 to add an RA sign-off and a check box for the Tech File file-sharing utility. Revisions of 90A0001-A01 and 90A0001-A02 updated to R and L, respectively.

Z. Nelson 11-19-15

AG 4273 Update section 6.2.2 to refer to form 90A0001-A02 for the required approval signatures.

S. Gupta 03-18-16

AH 4193 Added new section 11.3 for the use of obsolete documents for servicing legacy products. Modified section 10.2 to permit upper or lower case letters in filenames.

G. Partin 04-08-16

AJ 4338 Added Section 4.4 to include new hardware document type 96.

Included release notes and reference documents in Section 6.2.1. Added Section 7.8.3.1 to discuss how description of changes to 10C, 10M, and 10A drawings will be detailed in the corresponding 96A release notes for that board assembly. Added a row for release notes and reference documentation in Table 1.

AS 04-26-16

AK 4425 Added Quality System Process Interaction Diagrams, Manufacturing Plans, and Supply Chain to Table 1. Added new section 7.7.4 to consider changes to approved process interaction diagrams when releasing a new or revised quality system record. Updated 90A0001-A01 to Rev S to include Supply Chain approval. Deleted the explanation in 7.3 of the “@” symbol used to indicate revision “FI” in the OHMWARE manufacturing system since OHMWARE has been replaced with EPICOR

G. Partin 2-10-17


ZOLL Document Number: 90A0001 Page 7 of 25 Documentation Control REV AK

___________________________________________________________________________________________ Proprietary ZOLL

1. INTRODUCTION

This document establishes the procedures and controls for the creation, review, approval, distribution, retrieval and archival of ZOLL Manufacturing Corporation (ZOLL) documents required by FDA’s Quality System Regulation and ISO 13485 Quality Systems. These controls ensure that documents are reviewed for adequacy and approved prior to issuance; are available at all location for which they are designated, used, or otherwise necessary; and all obsolete documents are promptly removed from all points of use or otherwise prevented from unintended use.

2. SCOPE

This procedure applies to documents required by 21 CFR Part 820.40 and ISO 13485:2012 clause 4.2. Quality records (records maintained to demonstrate the conformance to specified requirements and the effective operation of the quality system) are outside the scope of this procedure (see 90E0004 – Maintenance of Quality Records).

3. APPLICABLE DOCUMENTS

90A0004 Product Development

90A0007 Software Configuration Management Policy

90A0022 Prototype Documentation

90A0023 Change Requests and Change Orders

90A0026 ZOLL Numbering System

90A0027 Entering Parts/Materials (P/M) Numbers into the Manufacturing System Database

90A0100 Establishment and Maintenance of the Device Master Record

90A0110 Establishment and Maintenance of the Technical File

90E0004 Maintenance of Quality Records

90G0100 Design History File

21 CFR Part 820 Quality System Regulation

ISO 13485 Medical Devices - Quality Management Systems – Requirements for Regulatory Purposes

93/42/EEC Medical Devices Directive of 14 June 1993



4. CONTROL NUMBER RESPONSIBILITIES

4.1 Documentation Control assigns control numbers to all Type 20, 90 and 95 documents, labels, labeling, advertising, and promotions.

4.2 Design Engineering assigns control numbers to all documents and drawings for assemblies, fabrications, test fixtures and tools, purchased P/Ms, and pertinent documentation sheets (10-19, 21 & 80).

4.3 Software Engineering assigns control numbers for all device software, programmed components and software documentation (91, 92, 93, 94).

4.4 Hardware Engineering assigns control numbers for hardware documentation not including component specifications, drawings, requirements, and procedures. These include documents such as hardware release notes and reference documents (96).

4.5 Refer to the latest revision of ZOLL 90A0026 for a description of the ZOLL numbering system.

4.6 If a question arises as to what should be the Type, Class, Root Number, or Extension for a particular P/M, Quality Assurance will resolve the issue.

5. DOCUMENTATION CONTROL

Documentation Control is responsible for maintaining all controlled electronic files and documents. Its responsibilities include:

5.1 Creating tracking numbers for Change Requests and Change Orders. (Details in ZOLL 90A0023.)

5.2 Maintaining Change Request and Change Order logs.

5.3 Issuing approved, new, or revised documentation.

5.4 Maintaining file storage of the originals of approved documents/drawings in a secured area with limited access. This includes both on-site and off-site storage of documents.

5.5 Maintaining electronic files of documents, when available, on the ZOLL network. The documents on the network may be accessed by ZOLL employees on a read-only basis.

6. DOCUMENT TYPES

6.1 Prototype Documentation: is any document (specification, procedure, plan, protocol, report, etc.), drawing, or software that is still in the design phase. When a document is at the Prototype stage, it is not yet under Documentation Control. The process for tracking and releasing prototype documentation is explained in 90A0022.



6.2 Controlled Documentation: Any document (specification, procedure, plan protocol, report, etc.), drawing, or software that has entered the Documentation Control System. This includes any document that requires an approved Change Order to change (i.e., a procedure), and any document that remains unchanged (i.e., an archival document). All product-related and quality system-related documents, including graphics and software, will be controlled.

6.2.1 Approved Documentation: Documents requiring approval signatures and subsequent Change Order to change or obsolete. Original documents and drawings are stored in hard-copy form in locked, limited-access files and/or electronically in a read-only directory on the ZOLL network, controlled by Documentation Control. These documents and drawings use a hard copy approval sheet 90A0001-A01 or 90A0001-A04 and revision history page 90A0001-A03. Documentation requiring the approval process include:

Policies

Procedures

Instructions

Plans

Software

Drawings

Requirement Specifications

Reference Documents

Release Notes

Component/Material Specifications

Labeling

Marketing and Advertising*

*Exception: Marketing and Advertising changes that do not modify existing claims or add new claims do not require a change order to implement.

6.2.2 Archival documents require approval signatures as shown on Form 90A0001-A02. These types of documents do not undergo revision; therefore, the revision level is N/A for Not Applicable. All such documents use Form 90A0001-A02 as a front cover. These documents may also be filed electronically and/or as a hard copy. The following are examples of documents that do not undergo revision or become obsolete:

Clinical study results and analyses



Engineering Test Reports

Other archival documentation

6.2.2.1 Archival Documentation: Constitutes an historical record of product-related work (i.e., Lab Notebooks), and therefore is prohibited from revision. Accordingly, the revision will be designated “N/A”, signifying Not Applicable.

6.2.2.2 QA Documentation: Because of its unique auditing and reporting responsibilities, Quality Assurance may establish intradepartmental documentation control for specified kinds of records, such as in-house and vendor audit reports. The nature of such documentation, as well as where they are stored/controlled is specified in the Maintenance of Quality Records SOP (90E0004).

6.3 Uncontrolled Documentation: Any document that remains outside the Documentation Control System. Uncontrolled Documentation may include, for example, certain facility related drawings, blueprints, and other non-product related drawings.

7. CREATING A CONTROLLED DOCUMENT

When a new document is to be created as an approved controlled document, the author shall:

7.1 Obtain a number.

7.2 Supply the “Title”.

7.3 Enter the revision in the revision block on the approval page (90A0001-A01, -A02 or -A04). All new documentation begins with revision level “FI” (for First Issue), unless the new document is an addition to an already existing controlled document, such as a new version of a bill of materials, in which case the new document shall carry the same revision as the existing controlled document. (Example: the current bill of materials for a 10A0160-A01 Monitor Assembly is revision “B”. A new German version is created (10A0160-A01-GER). The new 10A0160-A01-GER bill of materials will be released at revision “B”.)

7.3.1 Sequential alphabetic characters indicate revision levels: the first revised version of an approved document bears the REV designator A; a second revision is indicated by REV B. A twenty-third revision is identified as REV AA. (The letters “I”, “O”, “P”, and “Q” are not to be used to indicate revision levels for released documentation.)



7.4 Indicate on the approval page the level of review required for the document (see Review and Approval matrix in Section 8).

7.5 Create the document in an electronic file format, preferably, not handwritten.

7.6 When creating a document in an electronic format:

7.6.1 The file name format shall be as specified in section 10.2.

7.6.2 All text files should be formatted in Microsoft Word® format.

7.6.3 If spreadsheets are linked to a document, they must be kept on file with that document.

7.6.4 Record the file name, size, time and date on the approval page. This information must correspond exactly to the electronic file information for the document to be accepted by Documentation Control. *Note: File size, time and date should be handwritten on the approval page after all work on the document has been completed and saved.

When multiple files are linked to one approval page (such as multiple pages of a drawing) each file name, size, and time and date shall be recorded on the approval page.

7.7 Indicate on the approval page if the document affects a Device Master Record (DMR), a Device History File (DHF), is a Quality System Record (QSR), or is part of a Technical File (Tech File) required by the Medical Device Directive, as applicable. *Note: form 90A0001-A04 only requires a QSR indication.

7.7.1 If the document affects a DMR, DHF, or Tech File, the author shall indicate the overall system level (e.g. WCD, WCD 2000) and the Finished Device Level (e.g. Monitor, PBS, PPC, Garment, Electrode Belt, etc.).

7.7.2 If the document affects the DMR, the author shall then indicate if the document will require a DMR update in accordance with the Establishment and Maintenance of the Device Master Record SOP 90A0100.

7.7.3 If the document affects the Tech File, Regulatory Affairs shall determine if the document needs to be included in the Technical File file-sharing utility. Documentation Control is responsible for ensuring that the appropriate documents are added to the Technical File file-sharing utility.

7.7.4 If the document is a Quality System Record review the existing quality system Process Interaction Diagrams (see 90E0021 section 3.2) for any required changes resulting from the new or revised quality system record. Changes to an approved process interaction diagram require a change request/change order – see 90A0023.

7.8 Enter the Revision History information on the Document Revision History Page (90A0001-A03). If the document is being revised, obtain the current electronic file from the Documentation Directory which will already have the previous revision



history saved.

7.8.1 Rev will normally be “FI” for the first issue of a document. If the document is being changed via a change order (CO) the rev will be the next sequential revision letter.

7.8.2 CO Number: If the document is being changed via a change order (CO) enter the CO number.

7.8.3 Description of Change: If the document is being changed via a change order enter be a brief description of the change. For “FI” documents enter “First Issue of Document”.

7.8.3.1 Since changes made to 10C, 10M, and 10A drawings can be rather extensive and technical, a new document type, 96A: Hardware Release Notes, has been created to document these changes as well as explain the reasoning behind them. Therefore, the Revision History section for these document types will provide a general description of the change and a link to the corresponding 96A document, which will describe the changes in much more detail.

7.8.4 Author will be the author’s initials.

7.8.5 Effective Date will be entered by Documentation Control once the document is fully approved.

7.9 Circulate the document for review and approval as defined in section 8.

7.10 Once a document has been approved by all of those designated to sign it, the author must submit the original approval page, revision history page and an electronic file and/or hard copy to Documentation Control.

7.11 An archival document must be signed by the department head of the originating department, QA, and RA upon completion. It must then be turned over to Documentation Control.

7.12 If the file is in an electronic format, Documentation Control will verify that the file name, size, time and date matches the approval page. Documentation Control will edit the electronic file of the revision history page by adding the “Effective Date”. This edited file will then be copied over to the ZOLL network. Documentation Control will record the new electronic file “transfer” information on the approval page (90A0001-A01, -A02, or -A04), then sign and date in the “Documentation Control” box.

7.13 All controlled documentation originals are maintained by Documentation Control in locked limited-access files or on the ZOLL network. All documents submitted in electronic format shall produce the correct document when viewed or printed. It is the responsibility of the document submitter to verify this prior to submitting the electronic file.



8. DOCUMENT APPROVAL PROCESS

When a document/drawing is to be approved for release, the author is responsible for making certain that it is distributed to the necessary reviewers for their evaluation. This may include an informal review and approval from external customers to ensure customer requirements are met. External customer review and approval will be overseen by QA/RA. The author shall indicate the required review and approval signatures by checking the appropriate boxes on the approval page of the document. Review and approval of documents in Table 1 shall be performed by the department manager (or designee) or higher level authority. Review and approval of documents in Table 2 shall be performed by the senior management (or designee) as specified. The following table defines the level of review and approval required for each type of document:


__________________________________________________________________________________________ Proprietary ZOLL

Table 1:

Documents requiring Departmental Review and Approval (form 90A0001-A01 & A02)

Type of Document QA RA Mfg Eng Mfg / Service Supply Chain Eng Dept Mgr

Archival Documents (form 90A0001-A02)

Design & Development Plans

System & Device Level Requirements Specs

Lower Level Requirements Specs

Manufactured (In-house) Product Drawings, BOM’s & Specs

All other Product Drawings, BOM’s, & Specs

Release Notes and Reference Documents

Eng Test Plans, Procedures & Protocols

Mfg Procedures & Instructions

Inspection Instructions

Clinical Protocols, Procedures, etc.

Internal Process Validation Plans, Procedures, Protocols

Supplier Process Validation Plans, Procedures, Protocols

Labeling, manuals, etc.

Service Procedures & Instructions

Marketing and Advertising Materials

Technology Applications Policies & Procedures

Reconditioning and Service Policies & Procedures

Quality System Process Interaction Diagrams

Manufacturing Plans


__________________________________________________________________________________________ Proprietary ZOLL

Table 2:

Documents requiring Executive Management Review and Approval (form 90A0001-A04)

Type of Document President VP Eng VP Operations Director QA/RA

Quality System Manual

Standard Operating Procedures supporting the QSM (see exception * below)

*Corporate Quality Council SOP

*Employee Training SOP

*Electronic Records Back-up and Archival Procedure



8.1 The dated “Approval” signatures of those individuals indicated on the approval page for the document, are required for the document/drawing to be considered Approved Documentation and filed in Documentation Control or copied into the Documentation Control Directory. (Note: A new approval page is required for each revision - see 90A0023 SOP for Change Requests and Change Orders).

8.2 “Approval” requires the concurrence of all reviewers.

8.3 If changes to a draft document/drawing are made before all approval signatures have been obtained, the author must make sure that any person who signed before the changes were made be given the opportunity to review and approve the new changes. Draft copies are not required to be maintained.

8.4 If a document/drawing is withdrawn during the approval process, the author is responsible for notifying Documentation Control, which in its records will indicate that the document/drawing has been withdrawn, and accordingly update the Documentation Database.

9. DOCUMENTATION DATABASE

9.1 Documentation Control maintains a documentation database. This database may be accessed by ZOLL employees on a read-only basis via a PC connected to the ZOLL network.

9.2 The database provides a means for employees to:

Search for controlled documents by title or document number.

View the latest revision.

Identify the size of the hardcopy document (A, B, C, D, etc.).

Identify the status of the document: active (ACT) or obsolete (OBS).

Identify if the document is part of a Device Master Record (DMR), and if so, which DMR.

Identify if the document is a Quality System Record (QSR).

Identify if the document is part of a Design History File (DHF).

Identify if the document is part of the Technical File required by the Medical Device Directive.

The approval date of each revision.

All revisions of the document, associated Change Order numbers and approval date.



9.3 Documentation Control will update the database when a new document or a new revision of an existing document is released.

10. DOCUMENTATION CONTROL FILE MAINTENANCE

10.1 Documentation Control maintains original copies of all controlled documentation. Documents may be kept in hard copy and/or electronic format. Documents maintained as electronic files must have a hard copy approval page in the hard copy files. All electronic files will be located in the Documentation Directory on the ZOLL network. The directory is partitioned into a “Released” folder and an “Archive” folder. The latest revision of each electronic file shall be in the Released folder. Previous revisions will be located in the Archive folder.

10.2 Electronic File Format

10.2.1 All electronic files shall be stored in the format of the software application in which they were generated (e.g., .doc for Microsoft Word files, .xls for Microsoft Excel files, .dwg for AutoCad

files, etc.). Files may also be converted to an alternate format such as Adobe Acrobat .pdf format for inclusion in a Technical File or Intranet application. When necessary, hard copy documents may be converted to electronic format for access through the Documentation Directory or inclusion in a Technical File or Intranet application.

For consistency, electronic files should follow this naming convention and may use upper or lower case letters:

Document number_extension_extension (if more than one) _rev (revision letter) _page#(if file pages are stored individually) .extension of software application

examples: CAD Drawing 10a0320_a01_ger_revb_2.dwg

Word Document 90e0311_reva.doc

Electronic filenames for approval pages which are not integral to the document itself, such as approval pages for Bills of Materials (BOMs), drawings, and production routings, may have a 2 character identifier added to the document number to distinguish the approval page from the document (“bm” for BOMs, “dg” for drawings, and “pr” for production routings).

examples:

BOM cover sheet 10a0126bm_a01_revm.doc

Drawing cover sheet 10a0320dg_a01_ger_revb_2.doc

Prod Routing cover sheet 10a0320pr_a01_revfi.doc



*Exceptions to the above file name format:

Certain software programs, such as Protel, auto-generate lower level hierarchical file names for multi-page documents. Modifying these filenames would disable the hierarchical linking. These electronic file names need not follow the naming convention specified above.

11. DISTRIBUTING APPROVED DOCUMENTS

11.1 Only Documentation Control is permitted to make official copies of Approved Documents/Drawings. These copies are indicated by a red “Documentation Control” stamp.

11.1.1 Should an individual print a hard-copy of a document from the read-only Documentation Directory, this hard-copy shall be considered “void” and may not be used in place of an officially stamped copy.

11.1.1.1 This uncontrolled copy shall be destroyed immediately after use.

11.1.1.2 In no case shall an unstamped copy be used for manufacturing, test or inspection purposes.

11.2 Hard-Copy Distribution List

11.2.1 Documentation Control shall maintain a Hard-Copy Distribution List. This list shall indicate the individuals or locations (if any) of controlled hard-copies of the approved document. This list may be an electronic database or a paper list. This list shall be the vehicle for ensuring that new revisions are distributed to the proper locations and the old hard-copy versions are removed from service.

11.2.2 Documentation Control has the authority to add or delete entries from the Hard-Copy Distribution List.

11.2.3 Should an individual request a hard-copy of an approved document they shall be given the opportunity to be added to the distribution list. If the individual elects to not be added to the list, the document shall be stamped with an “Uncontrolled Document” stamp. “Uncontrolled Documents” will not be updated when a revision occurs. “Uncontrolled Documents” may not be used for manufacturing, test or inspection purposes.

11.3 Use of obsolete documents for servicing legacy products

11.3.1 At times, it may be necessary for service personnel to reference older revision documents when servicing legacy products. In the event an obsolete document is requested from Documentation Control the document will be stamped with a “Not Current Revision – For Reference Only – Do Not Use For Production” stamp.

11.4 All documents that have been revised are identified as such in the Documentation Database. The latest revision of a document is always identified in the



Documentation Database as soon as it has completed the approval process.

11.5 New Revision Distribution and Obsolete Document Recall

11.5.1 When a new revision of a document becomes available, Documentation Control shall identify those individuals or locations (if any) on distribution for controlled hard-copies of the approved document via the Hard-Copy Distribution List. Documentation Control shall complete the Document Distribution Control Form (90A0001-A05) appropriately and forward a copy of the form along with an official copy of the revised document to each identified individual or locations (if any).

When a document becomes obsolete, Documentation Control shall identify those individuals or locations (if any) on distribution for controlled hard-copies of the approved document via the Hard-Copy Distribution List. Documentation Control shall complete the Document Distribution Control Form (90A0001-A05) appropriately and forward a copy of the form to each identified individuals or locations (if any).

11.5.2 Upon receipt of the Document Distribution Control Form, each employee identified shall return their old revision or obsolete document to Documentation Control in a timely manner (within 1-3 work days for manufacturing, test, or inspection personnel).

11.5.3 If an employee’s controlled hard-copy of a revised or obsolete document is misplaced, the employee must notify their supervisor or manager. If a thorough search still does not produce the document in question, the employee and their supervisor or manager must complete the “Old Revision is NOT Available” section of the Document Distribution Control Form. The completed Document Distribution Control Form must then be returned to Documentation Control.

12. HANDLING ARCHIVAL DOCUMENTATION

12.1 In the case of Archival Documentation, the author should obtain the dated “Approval” signatures of his/her department manager or designee and QA; these approval signatures are sufficient for Archival Documentation. When the necessary approval has been obtained, the documentation should be submitted to Documentation Control for archiving. At that time, Documentation Control will enter the “Date” the documentation is archived.

12.2 Archival Documentation constitutes a historical record of product-related work and therefore is prohibited from revision. Accordingly, the “REV” designator shall be N/A, signifying Not Applicable.

12.3 Archival Documentation, by definition, is not distributed, but held in a limited-access archive. Copies may be released, upon request, by Documentation Control.

13. RETENTION PERIOD FOR OBSOLETE / SUPERCEDED DOCUMENTS



13.1 Documents that have been superseded or obsoleted via a Change Order (see 90A0023), shall be retained for a period of 12 years from the date the document was superseded or obsoleted.

14. EXTERNAL DOCUMENTS

External documents (such as ISO standards, IEC standards, UL standards, Medical Device Directive (MDD), etc.) which are referenced as part of ZOLL’s quality system, or are an integral part of the design / testing of ZOLL ’s products, shall be maintained by the Quality Assurance Department. A list of the available external documents shall be posted at various locations throughout the company. Quality Assurance is responsible for reviewing the list periodically to ensure the external documents are current. The cover page of the list shall indicate the date and signature of the last QA review and the next scheduled review date.

DOCUMENT APPROVAL PAGE


Title: Author: Date:

Approvals ( “ ” indicates approval signature required)

Mfg Engineering: Date:

Supply Chain: Date:

Mfg/Service: Date:

QA: Date:

Engineering: Date: RA: Date:

Documentation Control: Date Archived:

Electronic File info: (if applicable) *If multiple files (such as multiple sheets of a drawing) list file info separately

File name: Size (in bytes) Time & Date (or Date & Time)

Transferred File info: (To be completed by Documentation Control) File name: Size (in bytes) Time & Date (or Date & Time)

Does the Release of / Change to this document affect DMR? Does the Release of / Change to the doc. require DMR update? Does the Release of / Change to this document affect DHF? Does the Release of / Change to this document affect QSR? Does the Release of / Change to this document affect Tech File?

If “Yes”, must document be included in Tech File file-share utility (completed by RA and transferred by Doc Control)?

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

Complete this section if change affects DMR, DHF, or Technical File

List System(s) List Device(s) (ex. WCD 3100, WCD 4000) (ex. Monitor, Charger)

ZOLL Form Number: 90A0001-A01 Form REV Level: S

ARCHIVAL DOCUMENT APPROVAL PAGE


N/A

Title:

Approvals Author:

Date: Dept Mgr: Date:

RA: Date: QA: Date:

Electronic File info: (if applicable) File name:

Size (in bytes) Time & Date (or Date & Time)

Transferred File info: (To be completed by Documentation Control) File name:

Size (in bytes) Time & Date (or Date & Time)

Does the Release of this document affect DMR? Does the Release of / Change to the doc. require DMR update? Does the Release of this document affect DHF? Does the Release of this document affect QSR? Does the Release of this document affect Tech File?

If “Yes”, must document be included in Tech File file-share utility (completed by RA and transferred by Doc Control)?

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

Complete this section if change affects DMR, DHF, or Technical File List System(s) List Device(s) (ex. WCD, WCD 2000) (ex. Monitor, PBS, PPC)

Archival Only, Not Subject to Revision

Doc. Control Date Archived

ZOLL Form Number: 90A0001-A02 Form REV Level: L



Title:


Rev

CO

Number


Author

Effective Date


EXECUTIVE MANAGEMENT APPROVAL PAGE


Title: Author: Date:

Approvals ( “ ” indicates approval signature required)

President: Date:

VP Eng: Date:

VP Operations: Date:

Director QA/RA: Date: Documentation Control: Date Archived:

Electronic File info: (if applicable) *If multiple files (such as multiple sheets of a drawing) list file info separately


Transferred File info: (To be completed by Documentation Control)


Does the Release of / Change to this document affect QSR? Yes No

ZOLL Form Number: 90A0001-A04 Form REV Level: N

DOCUMENT DISTRIBUTION CONTROL FORM

Document Number: Old Revision: New Revision: Date:

Distribution:

Action: ( “ ” indicates action required)

The document identified above has been revised and you are on distribution for a controlled copy. A new revision is attached. Please return your old revision only to Documentation Control with your name written on it and discard this form. However, if you are unable to produce your old revision, complete the “Old Revision is NOT Available” section below and return this form to Documentation Control.

The document identified above is now obsolete and you are on distribution for a controlled copy. Please return your old revision only to Documentation Control with your name written on it and discard this form. However, if you are unable to produce your old revision, complete the “Old Revision is NOT Available” section below and return this form to Documentation Control.

Old Revision is NOT Available:

Employee on Distribution

I cannot produce the old revision as requested. I have searched for the document and to the best of my knowledge certify that it has been removed from service.

Signature: Date:

Employee’s Supervisor or Manager

I agree that this employee has searched and found no other copies of this document.

Signature: Date:


Form REV Level: J