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What is Documentation?
Documentation includes both Documents and Records required for any organization. Documents are created by planning what needs to be done, and Records are created when something is done.
Normally, the Quality Management Documentation structure of any organization deals with 4 Levels of documentation.
Level 1 deals with:
- Quality Policy Manual which is Policy statements, methods of dissemination, and linkages to procedures work instructions and Records.
Level 2 deals with:
- Quality Procedures Manual, documented Procedures, linkages to Work Instructions, and Quality Records.
Level 3 deals with:
- Quality Work Instructions usually kept near the work area. Level 3 provides details on how Quality Records and Productions can be recorded and used.
Level 4 Deals with:
Quality Records, Data Sheets, C-Charts, Q-Charts, and other evidence on how Records are maintained. This is the area which has documents which may be required as evidence for implementing Quality Control measures and the documents required to provide Quality Assurance.
- Mandatory requirements from the standard: these are the documents necessary as stated in the standard. Mandatory documents are those documents which can be shown as evidence to auditors to confirm the implementation of the standard.
- Customer requirements: Documents may be required by customers to assure that Quality Procedures and Processes are followed for the organization to deliver a quality product or service.
- Any industry or statutory and regulatory requirements: Documents that are necessary to satisfy government and legal agencies regarding compliance to federal and state regulations are called the Statutory and Regulatory Documents.
- ISO 9001:2015 requires less mandatory documentation over ISO 9001:2008.
Normally, this constitutes the identification number, date of effective use, the name of the approving authority, revision status, and number of pages. The following is an example of the Document Control elements required on each document:
Document Number: Att4.4.41-01
Revision No.: 1
Effective Date: 03/12/2019
Approved By: Production Manager
Number of Pages: 1 of 3
Records are nothing but forms that are filled with data from both operations and non-operations (or manufacturing and nonmanufacturing) processes.
Control of Nonconforming (N/C) Product:
These documents are used to segregate, select, and accept/dispose nonconforming items are called the Documents to Control Nonconforming Products/Services.
Internal Audits are the first effort to view the extent of compliance with a given standard in any organization and to record the same in an unbiased, objective way to achieve improvement and total compliance.
These are actions taken by the organization to analyze all possible causes to any nonconformity and to arrive at a solution that can be implemented to avoid future such nonconformities. Typically, this would be a reactive step.
These are proactive actions taken by an organization to prevent nonconformities from occurring and to mitigate the risk of any nonconformity from occurring.
More Required for Some Sector-Specific Standards:
- This documentation by QSE is unique, comprehensive, one-level, simplified, and easy to implement.
- The Documentation developed by QSE is evidence-focused, data-driven, very adaptable, simple, and single-level.
- Simplified Documentation for any standard is possible because of the involvement of the trainer (QSE CEO and President Mr. Baskar Kotte) in writing the standards and through his understanding of the intent of the standards.
- QSE presents an in-depth explanation of Documentation structure.
- QSE details the differences in the 4 Levels of Documentation and the methods to condense it to a unique, single-level Documentation Structure. This system is not available elsewhere.
- QSE trains organizations to understand the differences between Documentation Structure, Documented Information, and Documented Procedures which are not taught in any other course.
- QSE explains the importance of having comprehensive, simplified, single-level Documentation.
- QSE has helped over 700 organizations to get their ISO or other certifications. Our Documentation System is appreciated by all certification bodies in terms of clarity, simplicity, and audit friendliness.
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Frequently Asked Questions
QSE has helped over 700 organizations earn their certifications. There has never been a problem. If there is any auditor who does not understand or accept the documentation, then QSE will take up the matter and clarify and get the problem resolved at the highest level if required.
QSE’s philosophy of documentation is to make it lean and easy to implement so it meets all requirements of the standard in a concise and comprehensive manner.
QSE has assisted over 700 facilities in USA with this documentation. QSE prepares the Documentation (and performs Consulting) on the customer’s site, not in their offices, and with the involvement of relevant personnel. To the extent of admissibility by the standard, QSE tries to adapt the existing Documentation of the organization to QSE Documentation to facilitate the retention of practices. QSE also trains the relevant personnel in the organization on the importance and methods of using the developed Documentation.