6.3 ISO 9000 Quality Plans - Optional

6.3 ISO 9000 Quality Plans—Optional

The optional requirement for quality plans is stated as a note in ISO 9001:2000, 7.1: Planning of Product Realization, and its definition was discussed previously. About 40 years ago, quality plans were very common in MIL-Q-9858 quality-control systems and consisted of bubble flow charts with all of the associated documentation affixed to the chart. Today, quality plans vary greatly and are an integral part of the QS-9000 requirements ^[1], and are discussed in some detail in ISO 10005:1995(E) ^[2].

6.3.1 Sounds Like a Process

A quality plan sure sounds like a process, and indeed it is (i.e., it is a description of a set of interrelated or interacting activities that transform inputs into outputs). As a result, the old bubble chart configuration is as true today as it was 40 years ago and is a very useful rule in the creation of a quality plan graphic (see Figure 6.4).

Figure 6.4: Quality plan to build an electronic device. Process flow with documentation = quality plan (when documentation stipulates resources required).

We have termed the quality plan as optional because the Standard uses the term as a note and notes are informative (guideline) as opposed to normative (required).

Quality or control plans are useful in all types of organizations. Table 6.5 is the first page of a quality plan that could be used for a general contractor. Notice that the documentation requirements are separated into operational and quality-control references.

Table 6.5: Quality Control Plan for the New Construction Project (Sample Page)

Stage	Step	On-Site Activity (Refer to Project Management Procedures)	Operational Documents	Quality and Safety Control Activities	QC Documents/Standards
Job files	1.0	Set up site office files	Project management procedures stage II	Site preparation	Site preparation checklist
	2.0	Superintendent files
	3.0	Prepare for receipt of contract
Mobilization and start up	1.0	Develop site utilization plan and mobilize temporary facilities	Project management procedures stage IV	Site preparation Post Occupational Health and Safety Association (OHSA) poster Hard hat required sign Location of MSDS sheets	Site preparation checklist Form S.3.4
	2.0	Post required signs
	3.0	Review building requirements
	4.0	Establish charge accounts
	5.0	Arrange for equipment delivery
	6.0	Establish safety procedures		Hazard communication engineering MSDS sheets Company safety program OSHA form no. 200 First-aid equipment. Protective gear GFI protection requirements	See Appendix S: Safety Reports and Forms in the Project Management Procedure
	7.0	Complete site checklist: Company policy Safety program Substance abuse program Hazard communication program	SITEPREP Form R.8
	8.0	Prepare access to job site	NSC change order	Crossing required	Railroad rules
Design and engineering	1.0	Subcontractors provide applicable drawings	Final design package	Design package reviewed by engineering	Plans and specs
	2.0	Survey and stake out areas	Plans	Check for accuracy of the layout Field notes	Owner bench marks and baselines are used
	3.0	Locate structures and lines	Plans	Check for accuracy of the layout Field notes
Note: Based on the work of the Robinson Construction Co., 215 N. West Street, Perryville, MO 63775, General Contractors.

6.3.2 Device Master Record Technique

Another technique used to create a quality plan is to form a device master record (DMR) that either contains or sends the reader to the following ^[3]:

• Device/system specifications;

• Total manufacturing process specifications;

• Quality-assurance procedures and specifications;

• Packaging specifications;

• Labeling specifications;

• Installation procedures and methods;

• Maintenance procedures and methods;

• Servicing procedures and methods.

It is necessary to make a clear statement in the manual that indeed the quality plan for a given product is formed by the DMR. The DMR is complete when you can prove that the required device can be completely built and shipped to its performance specifications based on only the DMR protocols.

For this medical device protocol, the actual performance of the device throughout its life cycle is captured in the device history record (DHR). The design phases are maintained in the design history file (DHF). The manner in which the device meets its compliance requirements is kept in a technical file. The higher-level documentation is maintained in the quality system record (QSR)—that is, documents not specific to a particular device such as management reviews and metrology procedures. The technique is readily expandable to any organizational product structure and can be termed, for example, the systems master record (SMR), the systems history record (SHR), and so forth.

^[1]See, for example, Advanced Product Quality Planning (APQP), Reference Manual, from AIAG, June 1994, tel: [phone].

^[2]ISO 10005:1995(E) presents several typical quality plan configurations that include plans for service organizations, manufactured product, processed material, and a software life cycle.

^[3]21 CFR Part 820 Quality System Regulation, FDA/CGMP Sec. 820.181, October 7, 1996.