J
JoHannah
Hi, Cove people.
I have been searching the “Documentation Systems, Forms, and Templates” thread as time permits. Thank you all for what you do. I’ve learned a lot. Sorry for this long post:
I need help. The government test lab where I work is seeking ISO 17025 accreditation. Some of our customers provide us with e-mail messages and attachments that contain time-sensitive information about their specifications: test methods, procedures, and related instructions and forms. Three or four people in the lab will receive the same e-mail and attachments, then I get a copy of the e-mail from one of them. Most, but not all of the documents have effective dates or revision levels on them. Effective date is always in the body of the e-mail. Most of the documents we get via e-mail from these customers are posted on their Internet Web sites, usually within a day or two of when we get the e-mail. Not that big of a deal, if nothing goes wrong. But there's a lot of room for error and what looks to me like a nightmare of copies of records to properly dispose.
When I get the e-mail, I ask my boss who should get hard copies. I print the relevant messages and attachments, stamp them controlled, and distribute the copies. I log the distribution information on that customer's master list. The customers usually provide doc numbers; when they don't, I give them a "CustomerProject-001." If there's no revision number or effective date on it, I just log the effective date they give in the e-mail. I keep each project in a ring binder: all project procedures and work instructions. Other correspondence related to the project is kept in a separate file.
Does this meet section 4.3 of ISO 17025 (which is just one of the standards related to documentation and record keeping that we have to meet)? Is there a better way to identify, on a master list or distribution lists, the current revision status and distribution of test methods, procedures, and forms that are printable from the World Wide Web? Paper copies, stamped "Controlled," of all the instructions are distributed to workers in the affected area and replaced as necessary, but the e-mails and attachments go who knows where; the Internet version is available to everyone at all times. There's nothing to prevent outdated versions of e-mail attachments or Web content from floating around the lab as hard copy or Adobe pdf. So that means for Customer-SOP-123 we have (for example):
-2 paper copies in identifiable physical locations
-3 or more identical electronic copies that came as e-mail attachments that are (maybe) stored in identifiable locations
-1 Adobe pdf on the Web at an identifiable URL to which all lab staff have access
-An unknown number of paper and electronic copies of the e-mail attachments
-An unknown number of paper and electronic copies that have been downloaded from the Web site.
How do you provide accurate distribution information for these things on the master list? What are the fields? How could you make a distribution list that shows this information? I guess we could just have a policy that says, “all paper copies are uncontrolled,” but that to me wouldn’t meet the spirit of the standard since it is often the paper copy -- not the electronic version on the other side of the room -- that actually guides the data-producing activity. If someone in the lab runs samples using a copy of a method that was printed from the Internet two days ago, and the copy is now obsolete, the data will not meet customer requirements. Not only that but…. And if someone has a printed version of an Internet download or e-mail attachment that IS the current version, don’t we still have to account for that instance of distribution, even if it is only for two days or whatever? How else could we know that the guy who ran the test had a copy of the correct version of the method at the time the samples were run?
I’m relatively new at this place (newer by years than the lab’s 17025 aspirations) and have recently become responsible for our “document control system,” which consists of a written procedure that addresses only internally-generated paper documents. I don't have any authority; my only power is the power of suggestion. There are less than 100 people in the lab. We use documents in paper, electronic, or both formats. People need and tend to want hard copies of methods and other instructions, but also refer to editable electronic versions that have been copied to myriad locations all over the share directory. This is what I inherited. Hostility to all things ISO and resistance to change are deep. We have made some progress by starting a master list of internal documents and master lists of documents we get from customers. We have also begun distributing internal documents electronically as locked PDF files (not editable Word files). To get even this far has been like pulling teeth. Are we pulling the right teeth? I would welcome any advice from Cove contributors. Thanks for all you have already done.
I have been searching the “Documentation Systems, Forms, and Templates” thread as time permits. Thank you all for what you do. I’ve learned a lot. Sorry for this long post:
I need help. The government test lab where I work is seeking ISO 17025 accreditation. Some of our customers provide us with e-mail messages and attachments that contain time-sensitive information about their specifications: test methods, procedures, and related instructions and forms. Three or four people in the lab will receive the same e-mail and attachments, then I get a copy of the e-mail from one of them. Most, but not all of the documents have effective dates or revision levels on them. Effective date is always in the body of the e-mail. Most of the documents we get via e-mail from these customers are posted on their Internet Web sites, usually within a day or two of when we get the e-mail. Not that big of a deal, if nothing goes wrong. But there's a lot of room for error and what looks to me like a nightmare of copies of records to properly dispose.
When I get the e-mail, I ask my boss who should get hard copies. I print the relevant messages and attachments, stamp them controlled, and distribute the copies. I log the distribution information on that customer's master list. The customers usually provide doc numbers; when they don't, I give them a "CustomerProject-001." If there's no revision number or effective date on it, I just log the effective date they give in the e-mail. I keep each project in a ring binder: all project procedures and work instructions. Other correspondence related to the project is kept in a separate file.
Does this meet section 4.3 of ISO 17025 (which is just one of the standards related to documentation and record keeping that we have to meet)? Is there a better way to identify, on a master list or distribution lists, the current revision status and distribution of test methods, procedures, and forms that are printable from the World Wide Web? Paper copies, stamped "Controlled," of all the instructions are distributed to workers in the affected area and replaced as necessary, but the e-mails and attachments go who knows where; the Internet version is available to everyone at all times. There's nothing to prevent outdated versions of e-mail attachments or Web content from floating around the lab as hard copy or Adobe pdf. So that means for Customer-SOP-123 we have (for example):
-2 paper copies in identifiable physical locations
-3 or more identical electronic copies that came as e-mail attachments that are (maybe) stored in identifiable locations
-1 Adobe pdf on the Web at an identifiable URL to which all lab staff have access
-An unknown number of paper and electronic copies of the e-mail attachments
-An unknown number of paper and electronic copies that have been downloaded from the Web site.
How do you provide accurate distribution information for these things on the master list? What are the fields? How could you make a distribution list that shows this information? I guess we could just have a policy that says, “all paper copies are uncontrolled,” but that to me wouldn’t meet the spirit of the standard since it is often the paper copy -- not the electronic version on the other side of the room -- that actually guides the data-producing activity. If someone in the lab runs samples using a copy of a method that was printed from the Internet two days ago, and the copy is now obsolete, the data will not meet customer requirements. Not only that but…. And if someone has a printed version of an Internet download or e-mail attachment that IS the current version, don’t we still have to account for that instance of distribution, even if it is only for two days or whatever? How else could we know that the guy who ran the test had a copy of the correct version of the method at the time the samples were run?
I’m relatively new at this place (newer by years than the lab’s 17025 aspirations) and have recently become responsible for our “document control system,” which consists of a written procedure that addresses only internally-generated paper documents. I don't have any authority; my only power is the power of suggestion. There are less than 100 people in the lab. We use documents in paper, electronic, or both formats. People need and tend to want hard copies of methods and other instructions, but also refer to editable electronic versions that have been copied to myriad locations all over the share directory. This is what I inherited. Hostility to all things ISO and resistance to change are deep. We have made some progress by starting a master list of internal documents and master lists of documents we get from customers. We have also begun distributing internal documents electronically as locked PDF files (not editable Word files). To get even this far has been like pulling teeth. Are we pulling the right teeth? I would welcome any advice from Cove contributors. Thanks for all you have already done.