Scan this QR Code with your phone and get bonus info on use­ful doc­u­men­ta­tion that comes with being an ISO 17025 lab

In a series of posts, I am going to intro­duce the reader to the exis­tence of ISO 17025 and its impor­tance.  I am going to intro­duce it in bite-sized bits for easy diges­tion.  Just like all mat­ters of learn­ing, knowl­edge is incre­men­tal over time and builds upon pre­vi­ous exposure.

In our first post we answered the ques­tion:  What is ISO 17025?

The next post we answered the ques­tion:  Why do we need stan­dards? Why ISO 17025 and pol­icy, pro­ce­dures and instruc­tions matter.

Then we answered the ques­tion:  Why is ISO 17025 so impor­tant to us in foren­sic science?

Just two days ago, we asked and answered:  Why should the crim­i­nal defense com­mu­nity care about ISO 17025?

A lit­tle while ago we exam­ined how ISO 17025 pro­vides a sim­ple method to develop themes to cross-examine experts.

One of the major ben­e­fits to the crim­i­nal prac­ti­tioner to the imple­men­ta­tion of ISO 17025 is the adop­tion of uni­ver­sal nomen­cla­ture. This will help us out demon­stra­bly with respect to dis­cov­ery. For exam­ple, I am sure in the past that when you have requested cer­tain doc­u­ments that we know must exist there is a tremen­dous amount of “hide the ball” wherein a request for a spec­i­fied item  is made, but because we did not use the par­tic­u­lar sui generis lan­guage of that par­tic­u­lar crime lab­o­ra­tory on that par­tic­u­lar day, the crime lab­o­ra­tory feigns igno­rance and reports that there is no such document.

Some crime labs play “hide the ball”

It is not so much that the con­cept behind the doc­u­ment request or the data behind the doc­u­ment does not exist, but rather through our under­stand­able igno­rance, we do not know the proper nomen­cla­ture for what to request.

The solu­tion for this can be found in ISO 17025 and in par­tic­u­lar sub­part 4.3 (Doc­u­ment Con­trol). Per 4.3, there is a clear delin­eation between con­trolled and uncon­trolled documents.

• Con­trolled doc­u­ments can be char­ac­ter­ized as those doc­u­ments which once the lab­o­ra­tory dis­sem­i­nates them, it becomes the respon­si­bil­ity of that lab­o­ra­tory to seek out those who have a copy of them, col­lect the old doc­u­ments and replace them with the new, most recent doc­u­ments in order to assure that the most cur­rent doc­u­ments are in use. There­fore, it would be extremely use­ful for a crim­i­nal prac­ti­tioner, for exam­ple, to obtain a con­trolled copy of the Pol­icy, Pro­ce­dure and Instruc­tions for par­tic­u­lar type of test. There­fore, in the fre­quent event that new doc­u­ments are adopted, it becomes incum­bent upon the lab­o­ra­tory, in order for it to keep its accred­i­ta­tion, to seek you out and replace your copy with the most cur­rent one.
• Uncon­trolled doc­u­ments are copies of the Poli­cies, Pro­ce­dures and Instruc­tions that exist at a finite point in time, but may not be the cur­rent ones in place and in use. A lab has no oblig­a­tion to update uncon­trolled documents.

Sec­tion 4.3 in con­junc­tion with Sec­tions 4.13 and 5.4.7 makes a very fine dis­tinc­tion between doc­u­ments and records. This dis­tinc­tion between doc­u­ments and records is crucial.

• “Doc­u­ments” include such writ­ings specif­i­cally labeled as “Poli­cies”, “Pro­ce­dures”, and “Instructions.”
• “Records”, on the other hand, are those which are gen­er­ated dur­ing the ana­lyt­i­cal process unique to the test on the sam­ple itself such as the chain of cus­tody, the par­tic­u­lar notes of the ana­lyst as well as the ana­lyt­i­cal device out­put in its raw form and finally the con­clu­sory opin­ion let­ter that is gen­er­ated that goes to the “cus­tomer” called the “Test Report”.

ISO 17025 in its attempt to employ uni­ver­sal nomen­cla­ture estab­lishes a clear dis­tinc­tion within the “Doc­u­ment” des­ig­na­tion.  The sub­sets of types of “Doc­u­ments” are: “Poli­cies”, “Pro­ce­dures”, and “Instructions”.

• “Poli­cies” answer the orga­ni­za­tional ques­tion of why. Why do we do this? Why is this impor­tant? As one can glean from this descrip­tion of what is con­tained in a well for­mu­lated pol­icy per ISO 17025, if one were to receive the pol­icy, for exam­ple, in pre-consumption (solid) drug dose exam­i­na­tion, this pol­icy could include some very use­ful lan­guage that has to do with the impor­tance of accu­racy, pre­ci­sion, reli­a­bil­ity, robust­ness, and the need to fol­low the pro­ce­dures and instruc­tions in order to obtain a valid result. The “Pol­icy” also answers the large insti­tu­tional ques­tion of who has con­trol over the lab­o­ra­tory. In the “Pol­icy”, who has con­trol of the devel­op­ment of the sci­ence is defined. Who devel­ops, imple­ments and mon­i­tors the under­ly­ing “Pro­ce­dure” and “Instruc­tions” is also defined. This could be most use­ful in order to show bias of the lab­o­ra­tory at an insti­tu­tional level.
• On the other hand, “Pro­ce­dures” are best clas­si­fied as answer­ing the ques­tions of who, what, where, and when. Who in gen­eral does the test­ing? Who has con­trol over the test­ing? What test­ing is to be per­formed? Where is test­ing to be per­formed? On what instru­ments is the test­ing to be per­formed? When is it to be per­formed? Under what cir­cum­stances are spec­i­mens to be tested?  What pri­or­i­ties are set in terms of scarce resources?
• Finally there are the “Instruc­tions”. This is where we find the tech­ni­cal aspects answer­ing the ques­tion how do I, as a bench tech­ni­cian, per­form this test specif­i­cally in my lab­o­ra­tory using the resources and equip­ment that are avail­able to me right now.

The addi­tional advan­tage to the crim­i­nal prac­ti­tioner is in the neces­sity to uni­formly doc­u­ment cer­tain parts of the ana­lyt­i­cal process as well as the method­ol­ogy and its val­i­da­tion that hereto­fore may not have been doc­u­mented at all in a crime lab­o­ra­tory. This is par­tic­u­larly true in the event of such test­ing agen­cies as the DEA. If one has “dealt” with a par­tic­u­lar regional lab­o­ra­tory of the DEA and attempted to dis­cover how a par­tic­u­lar ana­lyst ana­lyzes any pre-consumption (solid) drug dose sam­ple by request­ing the Stan­dard Oper­at­ing Pro­ce­dures (SOPs), it is a fre­quent occur­rence that the DEA will respond that there is no such SOP[i].

Under ISO 17025 Sec­tion 4.3, if one knows now the proper ter­mi­nol­ogy used in ISO 17025 , one will know to request not only the par­tic­u­lar instruc­tions of the analy­sis, but also the pro­ce­dures and the pol­icy. As such, the DEA will no longer be able to claim its pre­vi­ous posi­tion that they do not exist truth­fully in court.

As one can see that if one asks for the “Stan­dard Oper­at­ing Pro­ce­dures” for the lab­o­ra­tory expect­ing to get infor­ma­tion that is best answered per ISO 17025 nomen­cla­ture by request­ing the “Instruc­tions” of the test, a prac­ti­tioner will be sor­row­fully dis­ap­pointed in the result and will pos­si­bly not obtain the infor­ma­tion that is included in the “Instruc­tions.” Hence, the uni­form nomen­cla­ture is key and nec­es­sary to understand.

As men­tioned pre­vi­ously the impor­tant dis­tinc­tion of what con­sti­tutes a “Record” can be found in sec­tion 4.13 (Con­trol of Records) and is dif­fer­ent from Sec­tion 4.3, which deals exclu­sively with doc­u­ments. Again, “Records” are out­put from the ana­lyt­i­cal process as defined supra. Sec­tion 4.13.1.1 very specif­i­cally out­lines that, not only “Records” of the par­tic­u­lar ana­lyt­i­cal tests are to be kept, but also the entirety of the “Records” from the qual­ity con­trol mea­sures as well as the qual­ity assur­ance aspects of the process lead­ing up to the pro­duc­tion of the “Records” of the par­tic­u­lar ana­lyt­i­cal test­ing being pre­formed. This is impor­tant in that some lab­o­ra­to­ries in the past have dis­carded cal­i­bra­tion curves or the raw data that gen­er­ates cal­i­bra­tion curves. Now this will not be a pos­si­bil­ity under ISO 17025 pro­ce­dures. In addi­tion, per Sec­tion 4.13.1.2, not only are these items to be pre­served but also they are to be stored and retained in such a way that they are “read­ily retriev­able.” This should end the games­man­ship that the requested items are but a “nee­dle in a haystack” as has been undoubt­edly asserted in the past by lab­o­ra­to­ries as an excuse to not com­ply with dis­cov­ery demands or orders.

Addi­tion­ally, per 4.13.2.1, we will now be able to insist upon receiv­ing the raw data that is gen­er­ated as a result of any test­ing and to try to defin­i­tively estab­lish com­plete com­pli­ance with Melendez-Diaz and to make sure that “dry lab­bing[ii]” did not occur as the pro­vi­sion reads:

The lab­o­ra­tory shall retain records of orig­i­nal obser­va­tions, derived data and suf­fi­cient infor­ma­tion to estab­lish an audit trail, cal­i­bra­tion records, staff records and a copy of each test report or cal­i­bra­tion cer­tifi­cate issued, for a defined period. The records for each test or cal­i­bra­tion shall con­tain suf­fi­cient infor­ma­tion to facil­i­tate, if pos­si­ble, iden­ti­fi­ca­tion of fac­tors affect­ing the uncer­tainty and to enable the test or cal­i­bra­tion to be repeated under con­di­tions as close as pos­si­ble to the orig­i­nal. The records shall include the iden­tity of per­son­nel respon­si­ble for the sam­pling, per­for­mance of each test and/or cal­i­bra­tion and check­ing of results.

Fur­ther Note 2[iii] of this sub­sec­tion includes a pre­ferred def­i­n­i­tion of “Tech­ni­cal records” as the accu­mu­la­tions of data that may include such items as “forms, con­tracts, work sheets, work books, check sheets, work notes, con­trol graphs, exter­nal and inter­nal test reports and cal­i­bra­tion cer­tifi­cates, cus­tomers’ notes, papers and feedback”.

Finally, sec­tion 4.13.2.2 requires that obser­va­tions, data and cal­cu­la­tions shall be recorded at the time they are made, not later.

Turn­ing towards the specifics of a par­tic­u­lar test and a technician’s spe­cific per­for­mance, inter­nal audit­ing is addressed in Sec­tion 4.14.1 and in 4.14.2 requires that when error or devi­a­tions are dis­cov­ered that the lab­o­ra­tory shall notify its cus­tomers in writ­ing.  This could be very use­ful for obvi­ous reasons.

[i] This for­mer clumsy request can now be eas­ily iden­ti­fied as “Pro­ce­dure” and “Instructions”.

[ii] Dry Lab­bing is the act of gen­er­at­ing a con­clu­sory report or “Test Report” when no actual analy­sis occurs.

[iii] It is impor­tant to under­stand that per Sec­tion 1.3 “Notes” that appear after the require­ments are not require­ments, but they do pro­vide impor­tant clar­i­fi­ca­tion of the text and guid­ance for best practices.