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5.16 Potential Manual Readership

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.

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
Complete product specifications	Design engineering group	Exact file area	Specify individual
Installation process manual	Customer support group	Exact file area	Specify individual
Servicing process manual	Customer support group	Exact file area	Specify individual
Description of device with variants	Continuous engineering group	Online files	Specify engineering, IT, and document control team
Manufacturing process document	Operations	Online files	Specify IT and manufacturing team
Quality assurance process manual	Quality assurance and regulatory affairs (QA &RA)	Exact file areas and online files	Specify operations and quality assurance team
Master list of Standards	QA&RA	Exact file area	Specify one individual
Master list of all documents with QMS	Document control	Exact file areas and online files	Specify individual
Declaration of conformity	QA&RA	Exact file area	Specify individual
Purpose and objective of file	QA&RA	Exact file area	Specify individual
Intended use, classification, and rules	QA&RA	Exact file area	Specify individual
Essential requirements	QA&RA and design and development (D&D) engineering	Exact file area	Specify team
Risk analysis	QA&RA and D&D engineering	Exact file area	Specify team
Clinical data	QA&RA and D&D engineering	Exact file area	Specify team
Justify choice of materials with packaging	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
Clinical data	QA&RA and D&D engineering	Exact file area	Specify team
Sterility methods	QA&RA and D&D engineering	Exact file area	Specify team
Repeatability Methods	QA&RA and D&D engineering	Exact file area	Specify team
Method to notify the notified body on changes	QA&RA	Exact file area	Specify individual
Medical device reporting processes	QA&RA	Exact file area	Specify individual
Pertinent test data	QA&RA and D&D engineering	Exact file area	Specify team
Marketing literature	QA&RA and marketing and sales	Exact file area	Specify team
Authorized European representative	QA&RA	Exact file area	Specify individual

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).

Table 5.19: Classification of Potential Manual Readers
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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