Purpose

• To summarize the standard practices to be used in Engineering Documentation Control (EDC) / Configuration Management (CM), for training company people and to give to auditors, agencies, customers and suppliers.
• These standard practices cover the four major CM processes: Document & Release, BOM, Request, and Change.

Applicability

• All product design documentation processed by or affecting this CM function.

Introduction

• This system can and should be edited to suit your company environment, organization and terminology.
• This system is totally integrated, comprehensive, separated into unique standards for each single subject and has many notes to encourage editing for your unique operations.
• These concepts have helped companies to drastically reduce their process time and errors. Three workdays to release and five to six workdays average to change (with the ability to hand-carry in one half day) through the Doc Control part of the process.
• One person is designated as the CM manager. That person would, among other duties, oversee the editing of the Standards Manual in order to assure best currently attainable processes.
• These standards should be compatible with any ERP, PDM, CAD, etc., system but care should be taken to edit to fit with those systems’ use and terminology.
• This summary document should be created after implementation of those standards which can be readily implemented with the current situation at your company. It should be updated after every continuous improvement project.
• Do not expect any of the standards to be “static” but rather a continuously changing set while your processes are continuously improved. Update this document accordingly.

Concepts

• Basic elements must be in place as building blocks for the release, BOM, Request and Change Control processes. Those standards are listed in the Contents pages.
• Use of cross-functional teams in all the EDC processes is encouraged in order to achieve “buy-in” from key functions and to achieve manufacturability, testability, etc. The standards for such team activity are:

  05	Teams for All CM Processes
  19	Team in Release
  22	Team in Request
  25	Team in Change

• Team meetings in the release process and especially early in the design phase are used to discuss problems, manufacturability suggestions and cost reductions just as soon as they are identified. The Technical signatures are obtained by the cognizant engineer at the team meetings on the documents themselves. The traditional “Change Control Board” has been eliminated in favor of a technical review meeting and a carefully specified change team and process.
• There is a careful separation of Technical Documents into categories: Product Design, Service Support, Manufacturing Process, Sales, Quality and EDC Process documentation. We do not “bundle” with the design documentation in the processes. This separation allows:
  • Release of manufacturable Design Documentation in lead time to build or buy and without holding them up for other documentation changes.
  • Design document changes are fully defined during the Change Design Phase and incorporated into the masters during the CM phase.
  • Service Support technical documentation is separately controlled by the Publications function, Manufacturing Process technical documentation by the ME or IE function, Sales technical documentation by the Sales Support function and Quality technical documentation by the QA Engineering function.
  • Support, Manufacturing Process, Sales or Quality document changes (if affected by a design document change) are planned during the Change Design Phase, started during the CM Phase, and completed during the Implementation Phase.
  • Support, Manufacturing Process, Sales or Quality document changes, no matter the source, are not done by the same process / form(s) as the design documentation. Other process(s) and form(s) have been designed for those document changes. Such standards are approved by the CM manager and placed in this manual.
  • CM/EDC process documentation (these standards) are maintained online in a secured manner by use of a separate process, without use of the Release or Change form or processes.
• We have online work flow and forms so the action documents (Release, Request and Change forms) are distributed online, not in hard copy — the first step toward “less paper.” The released or change documents themselves are also not distributed in hard copy. The people and functions that require copies of the released or changed documents will obtain those documents online (via CAD, PLM or ERP) or in hard copy when and as needed (“pull system” not a “push system”).
• This company has three major phases of new product development. They are called Design & Development, Pilot and Production. Design Engineering has more detailed phases for new product development, but from a company perspective these three phases (coded E,S,P) will be identified on the design documents (rev date, numeric and alpha) and in the ERP and PLM system. Thus, one can tell the phase that an item can properly be valid for by looking either at the document or the system.
• The same form is used to release new designs and to change existing designs. The form instructions address both. The standards that support the Release process:

  18	Release Policy
  19	Teams in Release
  20	Phase Release

• The Bill of Material process (not exactly a process) is addressed in conjunction with the ERP/PLM systems. Standards clarifying the Engineering-Manufacturing interface and the requirement to approach a single BOM structure are:

  08	Quantity and Unit of Measure
  09	Bills of Material
  10	Approved Manufacturers List

• Any employee can request a design change/improvement/cost reduction. Requests are not changes and will not necessarily become changes. The request form and work flow process are in the following standards:

  21	Change Request Policy
  22	Team in Request
  23	Request Form

• The cognizant engineer has change control authority during the Design & Development phase. That engineer is the only person that CM/EDC will give a request to or accept a change from. A list of cognizant engineers is maintained in CM.
• All changes to Pilot and Production released items are only done by the process described in the change standards. The standards that support the change process are:

  24	Change Control Policy
  25	Team in Change
  26	Change Form
  27	Interchangeability
  28	Part Number & Revision Level Changes
  29	Change Classification
  30	Mark Up of Design Documents
  31	Effectivity
  32	Effectivity Management
  33	Disposition of Old Design Parts
  34	Impacted/Affected by a Change
  36	Change Design Complete
  37	Actual TrackingEffectivity Tracking
  38	Line-Down Change
  40	Tracing Changes

• The change process and responsibilities are divided into three major phases. The CM manager has overall responsibility for the process design for all phases. The basic responsibility for the fast and accurate processing of the Release or Change is as follows:

  1	Change Design Phase = Engineering Responsibility
  2	Doc Control / CM Phase = CM Responsibility
  3	Implementation Phase = Manufacturing Responsibility

• During the pilot phase the normal signature requirements can be shortened to only the cognizant engineer and manufacturing engineer — all other signatures can be skipped, but are informed and have “exception ability.”
• Engineering Change Classification is uniquely defined on the change form.
• Carefully specified use of marked-up design documents in a change is encouraged in order to prevent transposition errors and wasted time.
• Certain functions can originate a change for the cognizant engineer, using the change form, if a solution to the problem is known and agreed upon. This avoids many change requests and shortens the total process time.
• Only the change form can be used to change a design and associated documents when a document is in pilot or production phases. Change Request, Deviations, and other forms or processes are not used to change a document, item or product.
• Effectivity of the change by product affected is planned, re-planned as needed and the actual effectivity captured. This planning is done by (date, order, serial number, etc.). A unique point in the production process (pipeline) may also be specified. Production Control manages the effectivity plan, re-plan and tracing to actual.
• There is a “point of no return” in the process called “Design Complete.” There is a checklist requirement at this point according to the Change Design Complete Standard. This prevents the engineer from prematurely entering changes into the CM process which have not been modeled, tested, technically reviewed, complete, etc. After this point the change will proceed as designed and will not be held up, technically revised, expanded or other changes “piggybacked” on it. If the change is not technically correct another change form will generally be required to correct the problem.
• Specific provisions are made for disposing of old design material affected by each change. This prevents the accumulation of such material in “bone piles” in manufacturing.
• Closing a change form is done only after specific actions have been completed. The standard that supports this concept is:

  39	Closing a Change

• Configuration status accounting / reporting is accomplished by:

  40	Tracing Changes

• Field Changes are limited and addressed as an integral part of the change process. The change form must determine whether or not the change will be retrofit and on what basis. Before the change is closed, the field change form must be released. Standards which support field retrofit are:

  41	Change of Field Units
  42	Field Change Policy
  43	Field Change Order Form

• Costing of certain changes (ABC – Activity Based Cost) is provided for. The standard that describes that activity is:

  44	Costing Design Changes

• In order to minimize thru-put time, the work flow diagrams have expected average time entered on the diagrams or in the standards.
• A Configuration Management Technician monitors the entire process and aids the engineers thru the design release / redesign processes.
• When customer or regulator notification or approval is required the process starts early and has provisions for proceeding with measured risk. Note: Not specified in the process, but done at many companies, is a contractual clause to limit the time allowed for customer approval on non-interchangeable changes. (If approval / disapproval is not received in ten workdays the change is approved by default.)
• Terms and acronyms are precisely defined in standard #48. These terms and their use in every standard have been carefully edited.
• The process flow time, volume and quality are measured and reported to management, involved parties and interested parties. CM distributes those reports on a monthly or weekly basis. Speed of the processes is critical to profitability.
• Some other standards are included to enhance the basics and system processes.

Procedure

• See the process flow diagrams and forms attached to or in the applicable standard.

Primary Responsibility

• The CM manager is responsible for keeping this standard up to date.

Authorization