8.3 The Records Master List

An excellent rule that can be used to form the records master list is to first list all of the forms used by the organization. Invariably, most of those forms will be kept by someone in their files as a record of their acceptance, rejection, verification, identification, and categorization of their activities. Then, add in the more subtle records, such as management reviews, design reviews, responses to requests for proposals and quotes, and preventive action reviews.

8.3.1 Specific Records

As discussed previously, the Standard does call out a specific number of required records. However, as we saw, the classification is generic. As a result, it was necessary to interpret the spirit of the requirement. The shock on the faces of the records steward when the assessor asks to see a list of documents contained in the contract review files is not necessary.

Just remember that an assessor cannot assume what belongs in those files. The assessor must audit against what has been declared by the supplier as a quality record. The declarations can be challenged if they do not comply with the Standard or it is discovered that many documents are kept as records but are not included in the master records list. Organizations often keep more records than are specified in the Standard, and such records need to be listed because they are an integral part of the QMS.

Table 8.3 illustrates how a single chart can be used to clearly define organizational records. The chart indicates the key parameters of process recorded, type, responsibility, location, and retention time.

Table 8.3: Partial Master Records List of Typical Records
Business Process	Record(s) Description (Form Used—A Few Samples)	Retained by (Primary Copy)...	Location [Online or Hard Copy (HC)]	Retention Time
Executive	Quarterly management review minutes (FE-001) Business plan (FE-002) Quality policy (FE-003)	ISO 9000 management representative President ISO 9000 management representative	Online Online HC (posted)	Current plus one (C + 1) year C + 3 years Current version
Executive	In-house publications Market analysis	Executive assistant Vice president of sales and marketing	HC Online	C + 1 year C + 3 years
Marketing and sales	Quotes (FS-001) RFQs and RFPs Catalog price lists (FS-002) Sales orders (FS-003) Sales Acknowledgments Purchase orders	Sales administrator	HC HC Online HC HC HC	C + 5 years C + 5 years Current version C + 5 years C + 5 years C + 5 years
Engineering	Engineering change requests and notices List of Standards Technical files Design review minutes Risk and hazard analysis Device master record	Engineering document control manager	HC Online HC Online Online HC	5 years after life of device
Operations	Preventive maintenance reports Shelf life records ESD records Receiving records Training records Purchase orders Approved vendor List	Plant engineer Warehouse manager Production manager Warehouse manager Vice president of operations Purchasing manager Purchasing manger	HC HC HC HC Online HC Online	C + 2 years C + 2 years C + 1 year C + 3 years End of employment C + 3 years C + 1 year
Quality assurance (QA) and regulatory affairs	Nonconforming material reports Device history record Supplier certificates of compliance and analysis Corrective action reports Preventive action reports Master document lists	QA document control supervisor	HC HC HC Online Online Online	5 years after life of device C + 1 year C + 1 year C + 1 year C + 1 year
Servicing	Return material authorizations Service reports	Administrative assistant	HC HC	C + 1 year C + 3 years

Notice that the category "master list" is included. Such lists are normally locally controlled documents that require a name and a date. However, they also contain information (e.g., current revision level, the location of the document, and who it is signed out to) that the assessor requires for objective evidence of, in this case, document control. This puts them into the category of a record.

8.3.2 Records Quantity

The number of records maintained by an organization is always a "bone of contention" with top management. Unfortunately, the harder you push to remove records, the more you will find. People need them to do their jobs—just make sure they are useful. I have witnessed an exercise in which an executive committee sat down to decrease the number of forms used by the company. Out of about 130 forms they removed nine … but added 16 more.

Scrap paper and computer transfer notes are not records. It is important to know when a form is maintained for a significant reason because many forms are really scrap paper and need not be controlled.

A good example of this is in a basically online system where raw data is taken daily and fed into a computer database at the end of the day. The form used to collect the raw data could have been just a notebook page, and, as a result, raw data sheets can be discarded. In this case, the record is controlled on electronic media.