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QMS Documentation Click the mouse to advance slides and animations in this slide show…
QMS Manuals and Documentation • Your core QMS Documentation is intended to be stored, read, and edited on your computer because you may: • backup and protect your work/files on CD. • prevent unauthorized access or editing of documents through file security options (i.e., read only or password protected documents). • Ensure that the most current version of the documentation is available to your employees and customers, and that other obsolete documents are appropriately managed/controlled.
*Quality Manual *Procedures Manual QMS Manuals and Documentation The majority of your QMS documentation is retained in 2 manuals on your computer: You should have already downloaded these by following Exercise 0.1 in your Workbook.
*Quality Manual The Quality Manual Includes: • An introduction to your farm business, including the SCOPEof your QMS. • A description of yourfarm’s processes and their interactions(i.e., PROCESS FLOW DIAGRAM) • Your Farm’s commitment to quality management (i.e., QUALITY POLICY) • Allegiance to ISO 9001:2000 for your QMS. (i.e., SECTIONS 4-8 of the Quality Manual)
*Procedures Manual The Procedures Manual Includes: • The 6 PROCEDURES that are required by ISO 9001:2000 • 14-19 RECORDS that are required by ISO 9001:2000 • Additional documentation that is needed to ensure effective planning, operation, and control of farm processes.
*Procedures Manual 6 Required Procedures • Document Control • Record Control • Internal Audit • Control of Non-Conforming Product • Corrective Actions • Preventative Actions Some of these procedures have already been added to your Manual (e.g., #1,2). Example procedures are also provided in the Ag-ISO WebPages. You will learn more about each of these while you work through the exercises.
*Procedures Manual Required Records • Management review records • Records of personnel education, training, skills, and experience • Records demonstrating that the products (and realization processes) meet all customer and legal requirements. • Records of the review of product requirements — prior to realization • Supplier evaluation and selection records • Validation of process for production and service provision records • Product Identification and traceability records • Records of loss or damage to customer property • Calibration verification • Internal audit records • Records of product conformity to requirements and release to customer • Records of Nonconforming products • Corrective action records • Preventative action records
*Procedures Manual The Procedures Manual Includes: • The 6 proceduresand 14-19 records that are required according to ISO 9001:2000 • Additional documentation that is needed to ensure effective planning, operation, and control of farm processes
*Procedures Manual Additional Procedures and Records... “that are needed to ensure effective planning, operation, and control of farm processes”. • The addition of procedures and records beyond those that are required by ISO 9001:2000 is completely up to you. • You will start your QMS by meeting the minimum documentation requirements (shown on previous slide). • You will then decide how additional documentation may be used to improve your QMS on an “as needed” basis. • The Ag-ISO Workbook and WebPages will lead you through the development of your manuals. Keep in mind that you MUST put into practice what you document in your QMS. Your documentation should be useful, but don’t write yourself into a corner by being too detailed or specific.
QMS Document Organization You should have already downloaded the Quality and Procedures Manual templates following Exercise 0.1 of the Ag-ISO Workbook. The following slides illustrate one method of QMS document organization that may help you to effectively keep track of your files.
Local Disk C:\ QMS Documentation Manuals QMS Records (hard copies) *Quality Manual *Procedures Manual QMS Records (electronic) reference QMS Document Organization The core of your QMS Documentation is generated, stored, and/or referenced in two manuals on your computer’s hard drive. When you set up your QMS you may want to organize your documentation into a main folder. QMS documentation will be stored in either the Manuals, or in separate electronic files. These may be organized into 2 subfolders. When you download the Quality Manual and Procedures Manual templates from the Ag-ISO WebPages, save them with a name appropriate to your farm (e.g., XYZ Farms Quality Manual.doc) in the Manuals subfolder. In some cases, the data you collect as part of your QMS will be referenced in your manuals, but stored in separate electronic files (e.g., yield maps). Organize these in the QMS Records subfolder. Some of your records will be printed hard copies of forms or external records (e.g., checklists, receipts). They should also be referenced in the Procedures Manual and organized in a file cabinet that is in a safe location. One of the benefits of this method of organization is that you can back-up your QMS files in one step by copying the “QMS Documentation” folder to a disk or CD.