Understanding The ISO/TS 16949:2002 Standard 

4.2.3 Control of Documents  

l        Control all documents required by your QMS  

l        Have a documented procedure that defines controls needed to: 

a)    Approve the adequacy of documents prior to issue 

b)   Review, update as necessary, and re-approve documents 

c)    Identify changes to documents as well as identify their current revision status 

d)   Make relevant versions of applicable documents available at points of use 

e)    Maintain documents so that they are legible and readily identifiable  

f)     Identify documents of external origin and control their distribution 

g)   Prevent the unintended use of obsolete documents, and apply suitable identification to these documents if they are kept for any purpose.  

Records are a special type of document (controlled by requirements in clause 4.2.4 

4.2.3.1 Engineering Specifications 

v  Have a process to timely review, distribute and implement all customer engineering standards/specifications & changes based on customers schedule 

v  These reviews should be as soon as possible and shall not exceed two working weeks 

v  Keep a record of the date that each change is implemented in production. Implementation shall include updated documents 

Note – PPAP’s need to be updated for changes in specifications referenced on the design record or for changes to PPAP documents such as Control Plans, FMEA’s, etc. (see 7.1.4). 

Key Explanation Points and Tips: 

Þ      As mentioned in clause 4.2.1 notes, a document is information that is written or recorded on some medium such as paper or computer. A document may specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan); or show results or evidence of activities performed (e.g. records). 

Þ      Clause 4.2.1 tells you what documents you must include in your QMS. All documents that you determine under clause 4.2.1 to be needed for your QMS processes must be controlled. This clause 4.2.3 provides requirements on how these documents must be controlled. Documents outside the QMS need not be subject to these controls. 

Þ      This clause requires you to have a documented procedure. Your procedure must - define responsibility for and description of the controls required by 4.2.3 a – 4.2.3g; methods to measure document control process performance; and continual improvement of the document control process.  

Þ      Ensure that your procedure specifically addresses each of the control requirements, in terms of who, what when, where and how as applicable. Your procedure must address new and old as well as internal and external documents used by the QMS.  

Þ      You must review your QMS documentation and determine if any updating or revisions are needed, and if they are changed, they must be re-approved. The frequency of this review, responsibility and method must be defined in your procedure. This will be determined by events within your organization and how mature or recent your QMS is. Auditors will explore this if your documents have not changed in years, while the nature of your business has changed significantly. 

Þ      Identify changes made to documents so users know exactly what has changed. There are many ways of doing this on printed as well as computerized documents. Your procedure must cover how this done. 

Þ      Have a method for revision control such as a revision log and masterlist of documents which identifies the current revision status. Again, there are other ways of doing this as well. Your procedure must cover how this done. 

Þ      Not all documents need to be available everywhere within your organization. You must determine what document is applicable (i.e. needed to assure product or process quality) to a specific process or activity and make the relevant version of that document available to that activity, e.g. providing current packaging and shipping work instructions to the shipping department. Also see clause 7.5.1.2 on accessibility of work instructions at work stations). Your procedure must cover how this done. 

Þ      Once you determine that certain documents need to be made available at various locations, implement some form of distribution control. There are many ways to do this. One way would be to keep a distribution log. Your procedure must cover your form of distribution control.  

Þ      Documents can take a beating in very harsh environments (covered in oil, dust, acid eaten, weather-beaten, etc.) to the point of being illegible. You must regularly review the condition of frequently used hardcopy documents to determine whether they need to be replaced. Your procedure must cover how this done.  

Þ      Documents must also be readily identifiable as to its purpose and scope. A simple heading may suffice, (e.g. In-process Inspection Sheet). Computerized documents are sometimes given file names that don’t identify its contents and this might require numerous files to be opened before you find the right one.  Identification also implies effective filing for timely retreival, whether manual or computerized. A frequent nonconformity is not being able to retrieve a document or record because of poor filing procedures. 

Þ      External documents (such as customer drawings or supplier material/part specifications) must be identified. There are many ways to do this. One way would be to keep a manual or computer list of these documents. Determine who needs them and have some form of distribution control to users to ensure they have the current or relevant versions of external documents. Your procedure must cover how this done. Review specific requirements for documents at OEM customer or IATF websites. 

Þ      Don’t overlook supplier, regulatory or industry documents. Apply applicable controls to these as well (4.2.3f). 

Þ      Obsolete documents can cause many problems if not controlled. There are many ways to do this. One way would be to provide computerized documents in read-only mode and make only the current version accessible at workstation computer screens. Obsolete hardcopy documents can be removed through distribution control.  Your procedure must cover how this or other methods are used.  

Þ      Ensure your procedure also covers methods to disallow unauthorized and unapproved or incorrect documents from being created, used or distributed. 

Þ      If documents are to be archived make sure that all such documents are properly identified, indexed and filed, and preferably have controlled or restricted access to them. Again your procedure must cover how this is done. 

Þ      Clause 4.2.3.1 - Engineering Specifications – calls for a process. You must therefore use clause 4.1a-f as guidance for documenting this process and include all the controls required by this sub-clause. For all changes to these customer provided documents, cross reference to PPAP documents such as Control Plans and FMEA’s. These documents may need to be revised and may require PPAP re-approval. If in doubt, check your PPAP reference manual or check specific customer requirements. 

Þ      Your process for engineering change control must also address any impact on lower level documents such as production work instructions. Develop appropriate linkage controls or checklist to ensure that such documents are appropriately updated. Also refer to clause 7.1.4 Change control. We will cover this later when we get to that clause. 

Þ      Nonconformities against document control are one of the most frequent audit findings. Develop appropriate performance indicators to demonstrate effective implementation of your document control process. Examples include – number of obsolete or unauthorized documents found being used; number of unauthorized changes found; number of instances documents were not available at points of use; etc. Track trends in these indicators and use this information to tighten your controls and continually improve your document control process. 

Þ      As mentioned in clause 4.1, use the PDCA to plan, implement, measure and improve your document control process. Your procedure should describe this approach.