Looking for:
Looking for:
Ipc/whma-a-620b download
This standard prescribes practices and requirements for the manufacture of Cable, Wire and Harness Assemblies. Such information should be developed with a statistical process control plan see Ipc/whma-a-620b download A brief ipc/whhma-a-620b follows each illustration.
The development committee recognizes that ipc/whma-a-620b download parts of the industry have different definitions for some terms used herein. For downlpad purposes of this document, downloaf terms cable and wire harness are used interchangeably.
Class 3 shall [N1N2D3] develop and ipc/whma-a-620b download a documented process control system. A documented process control system, if established, shall [N1D2D3] define process control and corrective action limits. This may or may not be a statistical process control system see 1. The use of statistical process control SPC is optional and should be based on factors such as design stability, lot size, production ipc/whma-a-620b download, and the needs ipc/whma-a-620b download the company.
Process control methodologies shall [N1D2D3] be used in the planning, implementation and evaluation of the manufacturing processes used to produce cables and wire harness assemblies.
The philosophy, implementation strategies, tools ipc/whma-a-620b download techniques may be applied in different sequences depending on the ipc/whma-a-620b download company, operation, or variable under consideration to relate process control and capability to downlaod product requirements.
Ipc/whma-a-620b download and tolerances use millimeters as the main form of dimensional expression; micrometers are used when the precision required makes millimeters too cumbersome Verification of Dimensions Actual measurement of specific part mounting and solder fillet dimensions and determination of percentages are not required except for referee purposes.
For the purposes of determining conformance to this specification, all specified limits in this standard are absolute ipc/whma-a-620b download as defined in ASTM E Where the word shall leads to a hardware defect for at least one class, the requirements for ipc/whma-a-620b download class are annotated in text boxes located adjacent to that occurrence in ip/whma-a-620b text. Where the word shall нажмите чтобы узнать больше to a hardware defect for at least one class, ioc/whma-a-620b requirements for each class are in brackets next to the shall requirement.
A defect for a Class 2 product means that the characteristic is also a defect for a Class 3 product, but may not be a defect ipc/whma-a-620b download a Class 1 product where less demanding criteria may apply.
When this standard doesn t provide acceptance criteria for ipc/whma-a-620b download specific class, the text box will note Not Est. However, the standard does provide criteria for commonly used technologies. Читать uncommon or specialized technologies по этой ссылке used, it may be necessary to develop unique acceptance criteria.
The development of unique criteria should ipc/whma-a-620b download user involvement or consent and ipc/whma-w-620b criteria developed should include an agreed upon definition for acceptance of each characteristic. The acceptance нажмите чтобы прочитать больше shall ipc/whma-a-620b download have user agreement. For the understanding of this document, selected definitions pertaining specifically to cable and wire harness manufacturing are listed below and in Appendix A.
Inspection An evaluation of quality characteristics relating to a standard, specification, or design drawing. Objective Evidence – Documentation in the form of hard copy, computer data, ipc/whma-a-620b download, or ipc/whma-a-620b download media. Process Control – A system or method to continually steer an operation in reducing variation in the processes or products to meet or exceed the goal in quality and performance.
Supplier – The individual, organization or company which provides to the manufacturer assembler components cables, wire harnesses, electronic, electromechanical, mechanical, printed boards, etc. Wire Downloqd D In this document, the outside diameter of the wire, including insulation if present Classes of Product Use of this standard requires agreement on the class to which the product belongs.
If the user ipc/whma-a-620b download manufacturer do not establish and document the acceptance ipc/whma-a-620b download, нажмите чтобы прочитать больше manufacturer may do so. Criteria defined in this standard reflect three Product Classes, which are as follows:. Class 2 Dedicated Service Electronic Products Includes products where continued performance and extended life is required, and for which uninterrupted service is desired but not critical.
Typically, the end-use environment would not cause failures. Class 3 Ipc/whma-a-620b download Performance Electronic Products Includes products where continued performance or performance-on-demand is critical, equipment downtime cannot be tolerated, end-use environment may be uncommonly harsh, ipc/whma-a-620b download the equipment must function when required, such as life support systems and other critical systems Order of Precedence Document Hierarchy In the event of conflict, the ddownload order of precedence applies: 1.
Procurement as agreed between user and manufacturer. Master drawing or master assembly drawing reflecting the user s detailed requirements.
Unless otherwise specified the requirements of this standard are not imposed on the procurement of commercial-off-the-shelf COTS or catalog assemblies or subassemblies. When a part is adequately defined ipc/whma-a-620b download a specification, then the requirements of this standard should be imposed on the manufacture of that part only when necessary to meet end-item requirements.
When doanload is unclear where flowdown should stop, it is the responsibility of ipc/whma-a-620b download manufacturer to establish that determination with the user. When an assembly is procured, that assembly ipc/whma-a-620b download meet the requirements of this standard. If the assembly is ipc/whma-a-620b download by the same manufacturer, the solder requirements are as stated in the contract for the entire assembly Personnel Proficiency All instructors, operators, and inspection personnel shall [N1D2D3] be proficient in the tasks to be ipc/whma-a-620b download.
Objective evidence rownload that proficiency shall ipc/whma-a-620b download be maintained and available for review. Supervised on-the-job training is acceptable until proficiency is demonstrated. For process control, more restrictive temperature and humidity limits may be required. Select tools to be used for ipc/whma-a-620b download, cabling, wiring, measuring, soldering, inspecting and in work preparation areas appropriate to the intended function.
Clean and properly maintain all tools and equipment. Examine all elements of tools for physical damage. Prohibit unauthorized, defective, or uncalibrated tools in the work area. Document detailed operating procedures and maintenance schedules for tools and ipc/whma-a-620b download requiring calibration or setups.
Maintain records of tool and equipment calibration and functional testing. Assure test fixtures, test adapters, and test equipment are maintained to assure the integrity of the test. Assure process tooling and process equipment are maintained to assure acceptability of the product. Crimping tools shall [N1D2D3] be calibrated or validated using a documented process. The minimum standard shall [D1D2D3] be assure: a.
Calibration of tools is performed in an environment compatible with the environmental requirements of the tools. Calibration intervals are based on the ipc/whma-a-620b download of tool and records of the tool’s calibration. Intervals may be lengthened or shortened on the basis of stability demonstrated over previous calibration periods. Procedures are ipc/whma-a-620b download and utilized for the calibration of all tooling stated herein.
Procedures include, as a minimum, standards to be used, parameters to be measured, accuracy, tolerances, environmental downlkad, and steps in the calibration process. The procedures ipc/whma-a-620b download be the supplier s specifications if judged adequate, and need not therefore be rewritten, but are documented.
Records ipc/whma-a-620b download maintained that document calibration. Tools are labeled to indicate, as a minimum: 1 Date of calibration. If not practical to place the label directly on ipc/whma-a-62b tool, then the label is affixed to the tool container or other location as documented in the procedures. When major elements of the proven processes are changed e.
Limited shelf life items shall [D1D2D3] be stored and controlled in accordance with material manufacturer s recommendations, or in accordance with the Supplier s documented procedures for controlling shelf life and shelf life The material specification ipc/whma-a-620b download other documented procedure shall opc/whma-a-620b be followed for mixing and curing.
Material shall [D1D2D3] be used within the pot life working time specified by the material supplier or used within the time period indicated by a documented system. When curing conditions http://replace.me/3127.txt, time, infrared IR intensity, etc. Equipment used for ipc/whma–a620b viscosity, mixing, applying and curing silicone material shall not [D1D2D3] be used for processing other material Figures ipc/whma-a-620b download Illustrations Many of the examples figures shown are grossly exaggerated to clearly depict the condition being described.
In the case of a discrepancy, the written description or written criteria always takes precedence over the illustrations Defects and Process Indicators Characteristics or conditions that do not conform to the requirements of this standard that are detectable by inspection or analysis are classified as either defects or process indicators.
Not all process indicators are specified by this standard. Process indicators should ipc/whma-a-620b download monitored but the hardware needs not be dispositioned, see It is the responsibility of the user to define unique defect categories applicable to the product.
It is the responsibility of the manufacturer to identify defects and process indicators that are unique to the assembly process Inspection Conditions For each section of this document, target, acceptable and defect conditions are listed for each product class.
Where applicable, по этому сообщению indicator conditions are also listed. The inspector ipc/whma-a-620b download not [D1D2D3] select the product class for the assembly under inspection.
Documentation that specifies the applicable class for the assembly under inspection shall [D1D2D3] be provided to the inspector. The descriptions of these conditions follow Target A condition that is close to perfect in the past has sometimes been labeled as “preferred.
It is a ipc/whma-a-620b download condition, not always achievable, and may not be читать далее to ensure reliability of ipc/whma-a-620b download assembly in its service environment Acceptable This characteristic indicates a condition that, while not necessarily perfect, will maintain the integrity and reliability of the assembly in its service environment Process Indicator A process indicator is a condition not a defect that identifies a characteristic that does not affect the form, fit, function or reliability of a product.
Process indicators should be monitored as part of the process control system. If the number of process indicators indicates an abnormal variation in the process, ipc/whma-a-620b download an undesirable trend, or displays other conditions that indicate the process is or is ipc/whma-a-620b download out of control, the process shall [N1N2D3] be ipc/dhma-a-620b. This may result in action to reduce the variation and improve yields. Disposition of individual process ipc/whma-a-620b download is not required ipc/whma-a-602b affected product should be used as is.
It is the responsibility of ipc/hwma-a-620b manufacturer to identify process indicators that are unique to the assembly process Defect A defect is a condition that ipc/whma-a-620b download to meet the acceptance criteria of this document and negatively affects the form, fit or function, of the assembly ipc/whma-a-620b download its end use environment. The manufacturer ipcwhma-a-620b [DN1D2D3] document and disposition each defect. It is the responsibility of the user to define unique defect categories applicable to the product Disposition Disposition is the determination of how defects should be treated.
Dispositions include, but are not limited to, rework, use as is, scrap or repair. A defect ipc/whma-a-620b download a Class 2 product means that the characteristic is also a defect for a Class 3 product, but may not be a defect for a Class 1 product where less demanding criteria may apply Conditions Not Ipc/whma-a-620b download Conditions that are not specified as defective or as a process indicator http://replace.me/20735.txt considered acceptable unless it can be established that the condition affects end user defined form, fit, function or reliability Electrical Clearance Electrical clearance spacing between conductors should be maximized whenever possible.
The minimum spacing between conductors and ipc/whma-a-620b download conductive materials ipc/whma-a-620b download as conductive markings or mounting hardware and conductors should be ipc/whma-a-620b download on the applicable drawings or documentation. When mixed voltages ipc/whma-a-620b download on the same assembly, the specific areas and appropriate clearances should be identified http://replace.me/6597.txt the drawings. Violation of minimum electrical clearance isshall [D1D2D3] be a defect.
The minimum electrical clearance distance depends on the circuit voltage rating and the normal volt-ampere rating. In cases where no minimum electrical clearance value is otherwise defined, the criteria in Table may be used as a guideline. Ipd/whma-a-620b lighting may be necessary to assist in visual inspection. Light sources should be selected ipc/whma-a-620b download prevent shadows ipc/whma-a-620b download the item being inspected except those caused by the item being inspected.
Light ranges from K enable dodnload to ipc/whma-a-620b download various metal and plating features and contaminants with increased clarity Magnification Aids and Lighting When required, magnification power for assembly inspection shall [A1P2D3] be at least the minimum inspection power specified in Table Other magnification powers within the inspection range may be used.
The magnification power requirement is based on the gauge of the wire being inspected. For assemblies with mixed wire sizes, the greater magnification may be used for the entire assembly. If the presence of a defect cannot be determined at the inspection power, the item is acceptable.
The referee magnification power is intended for use only after a defect ipc/whma-a-620b download been determined but is not completely identifiable at the inspection power. Supplemental lighting may be necessary to assist in visual assessment.
IPC WHMA A c Pdf Free Download – INFOLEARNERS.Previews IPC WHMA A B Pre | PDF | Coaxial Cable | Electrical Connector
Purpose This document defines requirements for suppliers providing aerospace and defense materials, products and services to Electromech Technologies. Soldering This worksheet and all related files are licensed under the Creative Commons Attribution License, version 1.
IPC/WHMA-AB Redline Document – PDF Drive
The magnification power requirement is based on the gauge of the wire being inspected. For assemblies with mixed wire sizes, the greater magnification may be used for the entire assembly. If the presence of a defect cannot be determined at the inspection power, the item is acceptable. The referee magnification power is intended for use only after a defect has been determined but is not completely identifiable at the inspection power. Supplemental lighting may be necessary to assist in visual assessment.
See 4. Handling of cleaned assemblies shall [N1N2D3] preclude recontamination. Rework shall [D1D2D3] meet all applicable requirements of this standard. Rework does not include a second application of a soldering iron during a hand soldering operation on a single connection Repair Repairs shall [N1D2D3] be conducted in accordance with a documented procedure.
The repair method shall [N1N2D3] be determined by agreement between the manufacturer and the user. Training is provided to personnel with assigned responsibilities in the development, implementation, and utilization of process control and statistical methods that are commensurate with their responsibilities.
Quantitative methodologies and evidence is maintained to demonstrate that the process is capable and in control. Improvement strategies define initial process control limits and methodologies leading to a reduction in the occurrence of process indicators in order to achieve continuous process improvement.
Criteria for switching to sample based inspection is defined. Chemical insulation stripping agents shall [D1D2D3]: Be used only for solid wires. Be neutralized or removed prior to tinning or soldering. The number of damaged scraped, nicked or severed strands in a single wire shall not [D1D2D3] exceed the limits of Table As an exception to Table Partial or incomplete cuts of strand groups shall not [A1A2D3] be in the crimp contact area.
Partial cuts of a strand group shall not [A1A2D3] be in a solder connection area or prevent contact of the strand group for the full length of the required wrap. Note: See Tools utilized to accomplish wire cuts shall [N1D2D3] be selected and used to provide repetitive and consistent wire cut terminations that meet the following criteria.
The process of wire cutting shall [N1D2D3] be performed such that the cut ends are uniform and all strands are the same length.
Figure A Fig Target Class 1, 2, 3 Wire conductor ends are cut perpendicular to the wire longitudinal axis. All of the strands of the strand group are the same length. Wires are not scraped, nicked, cut, flattened, scored, or otherwise damaged. All of the strands of the strand group are approximately the same length.
There are attached burrs that will not be dislodged during process or operation. Acceptable – Class 1 Process Indicator – Class 2,3 Strands cut, broken, scraped or severed if the number of damaged or broken strands in a single wire does not exceed the limits in Table Figure A Fig Defect – Class 1, 2, 3 Variation in strand length within a strand group that prevents installation to the full depth of the crimp contact area.
Damaged strands exceed the limits specified in Table As an exception to Table , partial cuts of a strand group that are in a solder connection area or could prevent contact of the strand group for the full length of the required wrap.
Note 2: For plated wires, a visual anomaly that does not expose basis metal is not considered to be strand damage. Figure A Fig Target Class 1, 2, 3 Strands are not flattened, untwisted, buckled, kinked or otherwise deformed. Original lay of strands is not disturbed. Figure A Fig Acceptable Class 1, 2, 3 Wire strands have separation birdcaging, shown by arrow and do not extend beyond wire insulation outside diameter.
Wire strands have separation birdcaging, shown by arrow but: do not exceed one strand diameter. Where strands were straightened during the wire insulation removal, they have been restored to approximate the original spiral lay of the wire.
Wire strands are not kinked. Figure A Fig Acceptable Class 1 Process Indicator Class 2 Defect Class 3 Wire strands have separation exceeding 1 strand diameter but do not extend beyond wire insulation outside diameter.
Acceptable Class 1 Defect Class 2,3 The general spiral lay of the strands has not been maintained. Acceptable Class 1 Defect Class 2,3 Wire strands extend beyond wire insulation outside diameter. Defect Class 1,2,3 Wire strands are kinked. The length of lay or “twist” as measured from the midpoint of wire’s crossover through a complete spiral to the next crossover midpoint of the same wire shall [D1D2D3] be 8 to 16 times the outer diameter of the bundle Figure Figure A Fig Acceptable Class 1,2,3 The length of lay for each twist is 8 to 16 times the outer diameter of the bundle.
Figure A Fig Defect Class 1,2,3 The length of lay for each twist is less than 8 or more than 16 times the outer diameter of the bundle. These criteria are also applicable to post-assembly acceptance.
Additional criteria for insulation damage as a result of soldering operations are provided in Figure A Fig Target – Class 1,2,3 Insulation has been trimmed neatly with no signs of pinching, pulling, fraying, discoloration, charring or burning.
Figure A Fig Acceptable – Class 1,2,3 A slight, uniform impression in the insulation from the gripping of mechanical strippers. Chemical solutions, paste, and creams used to strip solid wires do not cause degradation to the wire. Slight discoloration of insulation resulting from thermal processing is permissible, provided it is not charred, cracked or split. Insulation is charred Figure Criteria for forming soldered splices are provided in Section 8.
Criteria for heat shrinkable solder sleeves are provided in Sections 8 Splices and 15 Shield Terminations. When major elements of the proven processes are changed, e. Flux that is part of flux-cored solder wire [D1D2D3] meet the requirements of Flux percentage is optional. Solder alloys less than 0. When other activity levels or flux materials are used, data demonstrating compatibility shall [N1N2D3] be available for review.
Note: Flux or soldering process combinations previously tested or qualified in accordance with other specifications do not require additional testing. When an external flux is used in conjunction with flux cored solders, the fluxes shall [D1D2D3] be compatible Material, Components and Equipment – Materials – Adhesives Electrically nonconductive adhesive materials used for attachment of components should conform to an acceptable document or standard, e.
The adhesives selected shall not [D1D2D3] be detrimental to the component or assembly they are used on. The material shall [D1D2D3] be cured. When a solderability inspection operation or pretinning and inspection operation is performed as part of the documented assembly process, that operation may be used in lieu of solderability testing.
The manufacturer should establish procedures to minimize part solderability degradation. A wire or terminal not conforming to the solderability requirements may be reworked e.
Soldering irons, equipment, and systems shall [D1D2D3] provide appropriate temperature control and isolation from electrical overstress or ESD. These requirements may be eliminated if there is documented objective evidence available for review that there are no gold related solder embrittlement problems associated with the soldering process being used.
Flux residue can degrade product performance over time based upon environmental conditions. Methods and materials that are used to clean soldered assemblies shall [D1D2D3] be compatible with the product and assembly materials so that the cleaning process does not adversely affect performance characteristics. Solder connections produced using no-clean processes need only be cleaned when required.
Defect – Class 1,2,3 Dirt and particulate matter on assembly, e. Defect Class 1,2,3 Visible flux residue Cleanliness – Postsoldering – Flux Residue No-Clean Process Flux residue may be present if it is flux residue that is not intended to be cleaned. No illustrations. Flux residue does not inhibit access to test points of the assembly. No-clean flux residue on any electrical mating surface. There are specialized soldering finishes, e. The criteria should be based on design, process capability and performance requirements.
The acceptable solder connection must indicate evidence of wetting and adherence where the solder blends to the soldered surface. This standard provides visual criteria for inspection of both tinlead and lead-free connections.
Figures specific to lead-free connections will be identified with the symbol: Acceptable lead-free and tin-lead connections may exhibit similar appearances but lead free alloys are more likely to have: Surface roughness grainy or dull.
Greater wetting contact angles. All other solder fillet criteria are the same. Typical tin-lead connections have from a shiny to a satin luster, generally smooth appearance and exhibit wetting as exemplified by a concave meniscus between the objects being soldered. High temperature solders may have a dull appearance. Touch-up rework of soldered connections is performed with discretion to avoid causing additional problems, and to produce results that exhibit the acceptability criteria of the applicable class.
Undesirable wetting conditions are typically nonwetting and dewetting. Nonwetting is characterized as partial adherence of solder to a surface that it has contacted and basis metal remains exposed. Dewetting is a condition where molten solder coats a surface and then recedes to leave irregularly shaped mounds of solder on the surface that are separated by areas covered with a thin film of solder and without leaving basis metal exposed.
Some solders may have a dull appearance e. These should not be considered defective based upon their surface appearance. Rework touch-up of soldered connection defects should only be performed if required by disposition see Solder Connection – General Requirements The following general requirements are applicable to all terminals unless there is a specific requirement for a given terminal. Fillet is concave in shape.
No blowholes, pinholes or voids. Solder wicking allows the wire to remain flexible in required areas. Defect – Class 1,2,3 Solder has not wetted to the termination where solder is required nonwetting, dewetting. Disturbed solder. Cold solder. Overheated solder Fractured. Inclusions foreign material. Solder that violates minimum electrical clearance e. Lead or wire extensions that violate minimum electrical clearance. Contaminated solder connections e.
Solder wicking inhibits required flexibility where required. Solder wicking inhibits flexibility where required. The design does not restrict solder flow to any connection element. The visible portion, if any, of the connection is acceptable.
Process controls are maintained in a manner assuring repeatability of assembly techniques. Tinning of stranded wire has the added benefit of bonding the individual wire strands together, thereby allowing the wire to be formed to terminals or attachment points without separation of the individual strands. Limited solder wicking during tinning or soldering of wire is permissible as long as the solder does not extend to a portion of the wire that is required to remain flexible.
Wires will be formed into splices other than mesh and optional when heat shrinkable solder devices are used. Stranded wires shall not [D1D2D3] be tinned when: Wires will be used in crimp terminations.
Wires will be used in threaded fasteners. The following criteria are applicable if tinning is required: Untinned length of strands from end of wire insulation is not greater than 1 wire diameter D. Acceptable Class 1,2,3 The solder wets the tinned portion of the wire and penetrates to the inner strands of stranded wire.
Solder wicks up wire provided the solder does not extend to a portion of the wire that is required to remain flexible. The tinning leaves a smooth coating of solder and the outline of the strands are discernible.
Process Indicator Class 2,3 Strands are not discernible but excess solder does not affect form, fit or function. Solder does not penetrate to the inner strands of the wire. Length of untinned strands from end of wire insulation is greater than 1 wire diameter D.
Process Indicator Class 2,3 Strands are not discernible. Stranded wire is not tinned prior to attachment to terminals or forming splices other than mesh. Figure A Fig Defect Class 1,2,3 Solder build-up or icicles within the usable wire area that affect subsequent assembly steps.
Any method that produces an assembly conforming to the acceptability requirements described in this standard may be used. The User has the ultimate responsibility for identifying the Class to which the assembly is evaluated.
If the User does not establish and document the acceptance Class, the Manufacturer may do so. It is an important piece to the process, materials, and inspections standard for the cable and wire harness industry.
Recommended Standards and Publications are adopted by IPC without regard to whether their adop- tion may involve patents on articles, materials, or processes. By such action, IPC does not assume any liability to any patent owner, nor do they assume any obligation whatever to parties adopting the Recommended Standard or Publication.
Users are also wholly responsible for protecting them- selves against all claims of liabilities for patent infringement. Specification When an IPC publication is updated and a new revision is published, it is the opinion of the TAEC Revision Change that the use of the new revision as part of an existing relationship is not automatic unless required by the contract. The TAEC recommends the use of the latest revision. Adopted October 6, Why is there Your purchase of this document contributes to the ongoing development of new and updated indus- a charge for try standards and publications.
Standards allow manufacturers, customers, and suppliers to under- this document? Standards allow manufacturers greater efficiencies when they can set up their processes to meet industry standards, allowing them to offer their customers lower costs. There are many rounds of drafts sent out for review and the committees spend hundreds of hours in review and development.
Therefore, the standards and publications revenue is necessary to complement dues revenue. If your company buys IPC standards and publications, why not take advantage of this and the many other benefits of IPC membership as well? For more information on membership in IPC, please visit www.
All rights reserved under both international and Pan-American copyright conventions. Any copying, scanning or other reproduction of these materials without the prior written consent of the copyright holder is strictly prohibited and constitutes infringement under the Copyright Law of the United States.
Requirements and Acceptance for Cable If a conflict occurs between the English and and Wire Harness translated versions of this document, the English Assemblies version will take precedence. Any document involving a complex technology draws materials from a vast number of sources. Rhonda Troutman, Actronix Inc.
Julie Barker, Cristek Interconnects Inc. Vu Nguyen, Amphenol Canada Corp. Dale Lee, Plexus Corp. Sharon Ventress, U. Ken A. Moore, Omni Training Corp. Table Electrical Clearance The following topics are addressed in this section: 1.
If a conflict occurs between the English and translated Dimensions and tolerances use millimeters as the main form versions of this document, the English version will take of dimensional expression; micrometers are used when the precedence.
Any method that produces an assembly conforming to the 1. No limit is placed next to the shall requirement. The development committee recognizes that differ- Defect — Classes 2 and 3 ent parts of the industry have different definitions for some [A1A2D3] : Acceptable — Classes 1 and 2 terms used herein.
For the purposes of this document, the Defect — Class 3 terms cable and wire harness are used interchangeably. A documented process con- reflect general industry practices and procedures for guidance trol system, if established, shall [N1D2D3] define process only. The use of 1.