|
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.
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.
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 |
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.
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.
|