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We now enter into the realm in which our models and design theories come together to form documentation that relate in some incomplete way to reality. We must deal with an entity—the enterprise—that performs daily based on the interweaving of both effective and affective employee behavior in juxtaposition with an external environment that is essentially unpredictable—the marketplace. Effective behavior results from employee agreement with policy, process, procedure, and formats; affective behavior results from the psychological orientation of the employee due to both enterprise and general life stresses. The degree to which the employee accepts the effective portion of this duality is greatly impacted by the employee's affective orientation.
Unlike an electronic circuit board, we cannot hook up probes on our employees and measure currents and voltages that indicate our success or failure to meet specification. Our problem is that we are not only limited in our ability to fully project the dynamic behavior of our employees as they use the documents, but we cannot even predict the impact of our written words on our customers. The manual is a prime example of this weakness. However, as we analyze the problem, we can offer some effective solutions.
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Part 4.2.4.1: Technical File Compilation and Records
Procedure: Excellent's procedure to create a technical file for each product that requires medical device documentation is described in document MEDDEV-2-04-001, entitled "Medical Device Reporting Procedures."
The technical file is presented in the form of a table that indicates the specific requirement, the name of the document designed to meet this requirement, the location of the document, and the document's owner. The format of the table is as follows:
Technical File for Product:____________________
Content Requirement(s) | Documentation Responsibility | Document Location | Document Owner |
---|---|---|---|
| Design engineering group | Exact file area | Specify individual |
| Customer support group | Exact file area | Specify individual |
| Customer support group | Exact file area | Specify individual |
| Continuous engineering group | Online files | Specify engineering, IT, and document control team |
| Operations | Online files | Specify IT and manufacturing team |
| Quality assurance and regulatory affairs (QA &RA) | Exact file areas and online files | Specify operations and quality assurance team |
| QA&RA | Exact file area | Specify one individual |
| Document control | Exact file areas and online files | Specify individual |
| QA&RA | Exact file area | Specify individual |
| QA&RA | Exact file area | Specify individual |
| QA&RA | Exact file area | Specify individual |
| QA&RA and design and development (D&D) engineering | Exact file area | Specify team |
| QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA and D&D engineering | Exact file area | Specify team |
16. Labeling samples | QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA | Exact file area | Specify individual |
| QA&RA | Exact file area | Specify individual |
| QA&RA and D&D engineering | Exact file area | Specify team |
| QA&RA and marketing and sales | Exact file area | Specify team |
| QA&RA | Exact file area | Specify individual |
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Specifically, the manual is the most difficult ISO 9000 system document to write. Of all the ISO 9000 documents, it must appeal to the widest set of readers. As a result, the purpose of the manual must be carefully couched in terms of its users. We can classify the potential readers of the manual as follows (see Table 5.19).
Potential Readers | Includes | Reader Decision Needs |
---|---|---|
Customers/clients/partners | Executives Purchasing agents Quality assurance managers Operations managers Distributors Sales representatives Investors Interdivisional organizations | To audit or not to audit To buy or not to buy To invest or not to invest Initially based on the scope and completeness of the quality manual |
Employees | Executives Managers at all levels Engineers Supervisors Technicians Assemblers Buyers Marketing and sales personnel Internal quality auditors | Is the organization really committed to quality? How can I participate? What is expected of me as a quality person? What are the quality rules of the house? |
Subsuppliers | Subcontractors Vendors Interdivisional organizations | What level of quality is required? How will I be measured? What type of supplier audit can I expect? Will I be rewarded for my work? |
Third-party ISO 9000 evaluators | Assessors Registrars Accreditation boards Third-party experts | Degree of compliance to SHALLS Dedication of top management Potential for continual improvement and effectiveness of the quality system The extent to which quantitative methods are used to measure effectiveness |
As can be seen from Table 5.19, the potential readership for the manual is extremely diverse and must comply with an ever-expanding set of user needs.
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