Difference between revisions of "MDCCD Data Warehouse Data Dictionary"
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+ | {{Delete|reason=Moved to internal Health Canada wiki. Internal database structure should not be public.}} | ||
== Overview == | == Overview == | ||
This page provides a data dictionary for each table that is held within the [[MDCCD Data Warehouse]]. | This page provides a data dictionary for each table that is held within the [[MDCCD Data Warehouse]]. | ||
+ | |||
+ | '''DISCLAIMER''': All data in the "Example Data" column is fictitious and does not represent parties authorized under the ''Food and Drugs Act'' and/or the ''Medical Device Regulations''. | ||
== Medical Devices == | == Medical Devices == | ||
Line 8: | Line 11: | ||
This table holds the main inspection information. | This table holds the main inspection information. | ||
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 33: | Line 36: | ||
|No | |No | ||
|NULL | |NULL | ||
− | |00070- | + | |00070-MDCCD HEALTHCARE INC |
|This is the inspection number. | |This is the inspection number. | ||
| | | | ||
Line 42: | Line 45: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the company inspected. | |This is the unique record identifier for the company inspected. | ||
| | | | ||
Line 51: | Line 54: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |MDCCD HEALTHCARE INC |
|This is the name of the company insepcted. | |This is the name of the company insepcted. | ||
| | | | ||
Line 60: | Line 63: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | 1234 |
|This is the establishment licence number of the company inspected. | |This is the establishment licence number of the company inspected. | ||
|Use to join with MDS table ESTABLISHMENT.ESTABLISHMENT_ID. | |Use to join with MDS table ESTABLISHMENT.ESTABLISHMENT_ID. | ||
Line 69: | Line 72: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |123456 |
|This is the internal Health Canada company identifier. | |This is the internal Health Canada company identifier. | ||
|Use to join with MDS table ESTABLISHMENT.COMPANY_ID or COMPANY.COMPANY_ID. | |Use to join with MDS table ESTABLISHMENT.COMPANY_ID or COMPANY.COMPANY_ID. | ||
Line 78: | Line 81: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |HC1-11-11IM |
|This is the internal program based file identifier. | |This is the internal program based file identifier. | ||
| | | | ||
Line 132: | Line 135: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This is the name of the lead inspector. | |This is the name of the lead inspector. | ||
| | | | ||
Line 141: | Line 144: | ||
|Yes | |Yes | ||
| NULL | | NULL | ||
− | | | + | |9988776 |
|This is the badge number of the lead inspector. | |This is the badge number of the lead inspector. | ||
| | | | ||
Line 150: | Line 153: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier of the supervisor for the inspection. | |This is the unique record identifier of the supervisor for the inspection. | ||
| | | | ||
Line 159: | Line 162: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This is the name of the supervisor for the inspection. | |This is the name of the supervisor for the inspection. | ||
| | | | ||
Line 330: | Line 333: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This indicates who amended the inspection. | |This indicates who amended the inspection. | ||
| | | | ||
Line 393: | Line 396: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |613-123-4567 |
|This is the phone number of the emergency contact for the company at the time of inspection. | |This is the phone number of the emergency contact for the company at the time of inspection. | ||
| | | | ||
Line 402: | Line 405: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier of the senior official of the company at the time of insepction. | |This is the unique record identifier of the senior official of the company at the time of insepction. | ||
| | | | ||
Line 411: | Line 414: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
| This is the name of the senior official for the company at the time of inspection. | | This is the name of the senior official for the company at the time of inspection. | ||
| | | | ||
Line 420: | Line 423: | ||
|Yes | |Yes | ||
| NULL | | NULL | ||
− | | | + | |General Manager |
|This is the job title of the senior official for the company at the time of inspection. | |This is the job title of the senior official for the company at the time of inspection. | ||
|- | |- | ||
Line 428: | Line 431: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier of the contact of the company at the time of inspection. | |This is the unique record identifier of the contact of the company at the time of inspection. | ||
| | | | ||
Line 437: | Line 440: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This is the name of the contact of the company at the time of inspection. | |This is the name of the contact of the company at the time of inspection. | ||
| | | | ||
Line 446: | Line 449: | ||
| Yes | | Yes | ||
|NULL | |NULL | ||
− | | | + | |Manger, Quality Assurance |
|This is the job title of the contact of the company at the time of inspection. | |This is the job title of the contact of the company at the time of inspection. | ||
| | | | ||
Line 455: | Line 458: | ||
|Yes | |Yes | ||
| NULL | | NULL | ||
− | | | + | |613-123-4567 |
|This is the phone number of the contact of the company at the time of inspection. | |This is the phone number of the contact of the company at the time of inspection. | ||
|- | |- | ||
Line 463: | Line 466: | ||
| Yes | | Yes | ||
|NULL | |NULL | ||
− | | | + | | 613-123-4567 |
|This is the fax of the contact of the company at the time of inspection. | |This is the fax of the contact of the company at the time of inspection. | ||
| | | | ||
Line 472: | Line 475: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |john@mdccdhealthcare.com |
|This is the e-mail of the contact of the company at the time of inspection. | |This is the e-mail of the contact of the company at the time of inspection. | ||
| | | | ||
Line 481: | Line 484: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | 123 Main St |
|This is the address of the company being inspected. | |This is the address of the company being inspected. | ||
| | | | ||
Line 508: | Line 511: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |OTTAWA |
|This is the city of the company being inspected. | |This is the city of the company being inspected. | ||
|- | |- | ||
Line 525: | Line 528: | ||
|Yes | |Yes | ||
| NULL | | NULL | ||
− | | | + | |A1B 2C3 |
|This is the postal code of the company being inspected. | |This is the postal code of the company being inspected. | ||
| | | | ||
Line 543: | Line 546: | ||
| Yes | | Yes | ||
|NULL | |NULL | ||
− | | | + | |The meeting occured on March 1, 1994 with John Smith (Manager at MDCCD Healthcare and Mohamed Ali (Inspector at Health Canada) |
|This is the inspectors summary of the inspection. | |This is the inspectors summary of the inspection. | ||
| | | | ||
Line 552: | Line 555: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier of the contact of the company who received the final inspection report. | |This is the unique record identifier of the contact of the company who received the final inspection report. | ||
| | | | ||
Line 561: | Line 564: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | Mohamed Ali |
|This is the name of the contact of the company who received the final inspection report. | |This is the name of the contact of the company who received the final inspection report. | ||
| | | | ||
Line 579: | Line 582: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | |20230406 Inspector spoke with company to schedule inspection. Follow-up email sent to company | + | |20230406 Inspector spoke with company to schedule inspection. Follow-up email sent to company. |
|This is the inspector's internal comments and recommendations after the completion of the inspection. | |This is the inspector's internal comments and recommendations after the completion of the inspection. | ||
| | | | ||
Line 588: | Line 591: | ||
|Yes | |Yes | ||
| NULL | | NULL | ||
− | |Change in Regulatory | + | |Change in Regulatory Affairs department. Mr. Smith now in charge of complaint handling. |
|This indicates any personnel changes at the company inspected since their previous inspection. | |This indicates any personnel changes at the company inspected since their previous inspection. | ||
| | | | ||
Line 689: | Line 692: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This is the inspector's name who sent the inspection report for approval in the record log. | |This is the inspector's name who sent the inspection report for approval in the record log. | ||
| | | | ||
Line 707: | Line 710: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This is the supervisor's name who approved the inspection report in the record log. | |This is the supervisor's name who approved the inspection report in the record log. | ||
| | | | ||
Line 725: | Line 728: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This is the inspector's name who sent the inspection for closure in the record log. | |This is the inspector's name who sent the inspection for closure in the record log. | ||
|- | |- | ||
Line 742: | Line 745: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This is the supervisor's name who approved the inspection for closure in the record log. | |This is the supervisor's name who approved the inspection for closure in the record log. | ||
| | | | ||
Line 760: | Line 763: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
Line 778: | Line 781: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
| This identifies the resource that last modified the record. | | This identifies the resource that last modified the record. | ||
| | | | ||
Line 796: | Line 799: | ||
This table holds information about the corrective action plan for an inspection observation. | This table holds information about the corrective action plan for an inspection observation. | ||
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 812: | Line 815: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the CAPA. | |This is the unique record identifier for the CAPA. | ||
| | | | ||
Line 821: | Line 824: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the parent inspection. | |This is the unique record identifier for the parent inspection. | ||
|Use to join with MD_INS_CASE.INSP_ID. | |Use to join with MD_INS_CASE.INSP_ID. | ||
Line 830: | Line 833: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |00070-MDCCD HEALTHCARE INC |
|This is the parent inspection number. | |This is the parent inspection number. | ||
| | | | ||
Line 839: | Line 842: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the parent observation the CAPA is linked to. | |This is the unique record identifier for the parent observation the CAPA is linked to. | ||
| | | | ||
Line 857: | Line 860: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | |The | + | |The manufacturer sent an email to the inspector to indicate that the program has been solved. |
|This is the CAPA as inputted by the inspector. | |This is the CAPA as inputted by the inspector. | ||
| | | | ||
Line 866: | Line 869: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
Line 884: | Line 887: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
| This identifies the resource that last modified the record. | | This identifies the resource that last modified the record. | ||
| | | | ||
Line 902: | Line 905: | ||
This table holds information that categorizes or "tags" an inspection. These are flexible codes used to capture information if a designated field does not exist. | This table holds information that categorizes or "tags" an inspection. These are flexible codes used to capture information if a designated field does not exist. | ||
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 918: | Line 921: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the designation. | |This is the unique record identifier for the designation. | ||
| | | | ||
Line 927: | Line 930: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the parent inspection. | |This is the unique record identifier for the parent inspection. | ||
|Use to join with MD_INS_CASE.INSP_ID. | |Use to join with MD_INS_CASE.INSP_ID. | ||
Line 936: | Line 939: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | 00070- | + | | 00070-MDCCD HEALTHCARE INC |
|This is the parent inspection number. | |This is the parent inspection number. | ||
| | | | ||
Line 945: | Line 948: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the designation code. | |This is the unique record identifier for the designation code. | ||
| | | | ||
Line 989: | Line 992: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
Line 1,007: | Line 1,010: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
| This identifies the resource that last modified the record. | | This identifies the resource that last modified the record. | ||
| | | | ||
Line 1,025: | Line 1,028: | ||
This table holds information on the activities conducted by the company at the time of the inspection as recorded by the inspector. | This table holds information on the activities conducted by the company at the time of the inspection as recorded by the inspector. | ||
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 1,041: | Line 1,044: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the establishment activity. | |This is the unique record identifier for the establishment activity. | ||
| | | | ||
Line 1,050: | Line 1,053: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the parent inspection. | |This is the unique record identifier for the parent inspection. | ||
|Use to join with MD_INS_CASE.INSP_ID. | |Use to join with MD_INS_CASE.INSP_ID. | ||
Line 1,059: | Line 1,062: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |00070-MDCCD HEALTHCARE INC |
|This is the parent inspection number. | |This is the parent inspection number. | ||
| | | | ||
Line 1,068: | Line 1,071: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the activity value. | |This is the unique record identifier for the activity value. | ||
| | | | ||
Line 1,104: | Line 1,107: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
Line 1,122: | Line 1,125: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
| This identifies the resource that last modified the record. | | This identifies the resource that last modified the record. | ||
| | | | ||
Line 1,140: | Line 1,143: | ||
This table holds a listing of inspectors assigned to an inspection. | This table holds a listing of inspectors assigned to an inspection. | ||
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 1,156: | Line 1,159: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the inspector listing. | |This is the unique record identifier for the inspector listing. | ||
| | | | ||
Line 1,165: | Line 1,168: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the parent inspection. | |This is the unique record identifier for the parent inspection. | ||
|Use to join with MD_INS_CASE.INSP_ID. | |Use to join with MD_INS_CASE.INSP_ID. | ||
Line 1,174: | Line 1,177: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |00070-MDCCD HEALTHCARE INC |
|This is the parent inspection number. | |This is the parent inspection number. | ||
| | | | ||
Line 1,183: | Line 1,186: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | |John Smith |
|This is the name of the inspector. | |This is the name of the inspector. | ||
| | | | ||
Line 1,246: | Line 1,249: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
Line 1,264: | Line 1,267: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
| This identifies the resource that last modified the record. | | This identifies the resource that last modified the record. | ||
| | | | ||
Line 1,282: | Line 1,285: | ||
This table holds notes related to the inspection. | This table holds notes related to the inspection. | ||
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 1,298: | Line 1,301: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the note. | |This is the unique record identifier for the note. | ||
| | | | ||
Line 1,307: | Line 1,310: | ||
|No | |No | ||
|NULL | |NULL | ||
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the parent inspection. | |This is the unique record identifier for the parent inspection. | ||
|Use to join with MD_INS_CASE.INSP_ID. | |Use to join with MD_INS_CASE.INSP_ID. | ||
Line 1,316: | Line 1,319: | ||
|No | |No | ||
| NULL | | NULL | ||
− | | | + | |00070-MDCCD HEALTHCARE INC |
|This is the parent inspection number. | |This is the parent inspection number. | ||
| | | | ||
Line 1,343: | Line 1,346: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
Line 1,361: | Line 1,364: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
− | | | + | | John Smith |
| This identifies the resource that last modified the record. | | This identifies the resource that last modified the record. | ||
| | | | ||
Line 1,378: | Line 1,381: | ||
[[MDCCD Data Warehouse|Return to Home Page.]] | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
− | This table holds information | + | This table holds information about the observations for an inspection. |
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
Line 1,390: | Line 1,393: | ||
! scope="col" style="width: 350px;" |Comments | ! scope="col" style="width: 350px;" |Comments | ||
|- | |- | ||
+ | |OBS_ID | ||
+ | |VARCHAR2(36 CHAR) | ||
+ | |Primary | ||
+ | |No | ||
+ | |NULL | ||
+ | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | ||
+ | |This is the unique record identifier for the observation. | ||
| | | | ||
+ | |- | ||
+ | |OBS_NUM | ||
+ | |VARCHAR2(200 CHAR) | ||
| | | | ||
+ | |No | ||
+ | |NULL | ||
+ | |00070-MDCCD HEALTHCARE INC -obs0001132 | ||
+ | |This is the observation number. | ||
| | | | ||
+ | |- | ||
+ | |INSP_ID | ||
+ | |VARCHAR2(36 CHAR) | ||
+ | |Foreign | ||
+ | |No | ||
+ | |NULL | ||
+ | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | ||
+ | |This is the unique record identifier for the parent inspection. | ||
+ | |Use to join with MD_INS_CASE.INSP_ID. | ||
+ | |- | ||
+ | |INSP_NUM | ||
+ | |VARCHAR2(200 CHAR) | ||
+ | |Foreign | ||
+ | |No | ||
+ | |NULL | ||
+ | |00070-MDCCD HEALTHCARE INC | ||
+ | |This is the parent inspection number. | ||
+ | |- | ||
+ | |OBS_TYPE_EN | ||
+ | |VARCHAR2(200 CHAR) | ||
| | | | ||
− | | | + | |Yes |
− | | | + | |NULL |
+ | |MDR - Establishment licence | ||
+ | |This identifies the overall category of the Medical Device Regulations that the observation is cited under in English. | ||
| | | | ||
|- | |- | ||
+ | |OBS_TYPE_FR | ||
+ | |VARCHAR2(200 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |RIM - Licence d’établissement | ||
+ | |This identifies the overall category of the Medical Device Regulations that the observation is cited under in French. | ||
| | | | ||
+ | |- | ||
+ | |REG_SECTION_EN | ||
+ | |VARCHAR2(150 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |s.45 (f) Device classes | ||
+ | |This identifies the specific section/subsection of the Medical Device Regulations that the observation is cited under in English. | ||
| | | | ||
+ | |- | ||
+ | |REG_SECTION_FR | ||
+ | |VARCHAR2(150 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |MDR s.45 (f) Classes des instruments | ||
+ | |This identifies the specific section/subsection of the Medical Device Regulations that the observation is cited under in French. | ||
| | | | ||
+ | |- | ||
+ | |OBS_RISK | ||
+ | |NUMBER(1,0) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |1 | ||
+ | |This identifies the risk level of the observation. | ||
+ | |Scale 1-3. Risk 1 is the highest and risk 3 is the lowest. | ||
|- | |- | ||
+ | |OBS_REPEAT_EN | ||
+ | |VARCHAR2(30 CHAR) | ||
+ | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Repeat Observation | ||
+ | |This indicates if the observation has occurred before on a previous inspection with the company in English. | ||
| | | | ||
+ | |- | ||
+ | |OBS_REPEAT_FR | ||
+ | |VARCHAR2(30 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Observation répétée | ||
+ | |This indicates if the observation has occurred before on a previous inspection with the company in French. | ||
| | | | ||
+ | |- | ||
+ | |OBS_STATUS_EN | ||
+ | |VARCHAR2(50 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Open | ||
+ | |This indicates the status of the observation in English. | ||
+ | |- | ||
+ | |OBS_STATUS_FR | ||
+ | |VARCHAR2(50 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Ouvert | ||
+ | |This indicates the status of the observation in French. | ||
| | | | ||
+ | |- | ||
+ | |OBS_INCLUDEREPORT_EN | ||
+ | |VARCHAR2(3 CHAR) | ||
+ | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Yes | ||
+ | |This indicates whether the observation is included on the inspection report in English. | ||
| | | | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
+ | |OBS_INCLUDEREPORT_FR | ||
+ | |VARCHAR2(3 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Oui | ||
+ | |This indicates whether the observation is included on the inspection report in French. | ||
| | | | ||
+ | |- | ||
+ | |OBS_SEQ_NUM | ||
+ | |NUMBER(3,0) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |1 | ||
+ | |This indicates the order that the observations will print on the inspection report. | ||
| | | | ||
+ | |- | ||
+ | |OBS_STDLINE_EN | ||
+ | |VARCHAR2(1000 CHAR) | ||
| | | | ||
− | | | + | |Yes |
+ | |NULL | ||
+ | |A written procedure was not provided. | ||
+ | |This is a standard line related to the section of the regulation cited in English. | ||
| | | | ||
|- | |- | ||
+ | |OBS_STDLINE_FR | ||
+ | |VARCHAR2(1000 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Une procédure écrite n'avait pas été fournie | ||
+ | |This is a standard line related to the section of the regulation cited in French. | ||
| | | | ||
+ | |- | ||
+ | |OBS_NARRATIVE | ||
+ | |VARCHAR2(4000 CHAR) | ||
| | | | ||
− | | | + | |Yes |
− | | | + | |NULL |
− | | | + | |/*A written procedure was not provided. */ |
+ | |||
+ | |||
+ | The company did not have a written procedure in place for complaint handling. | ||
+ | |This is the inspector's narrative related to the observation. | ||
| | | | ||
|- | |- | ||
+ | |OBS_SUMMARY | ||
+ | |VARCHAR2(2000 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Observation #: 01 | ||
+ | |||
+ | Status / Statut : Open / Ouvert | ||
+ | |||
+ | Risk / Risque : 1 | ||
+ | |||
+ | MDR - Establishment licence / RIM - Licence d’établissement | ||
+ | |||
+ | MDR s.45 (f) Device classes / MDR s.45 (f) Classes des instruments | ||
+ | |||
+ | |||
+ | /*A written procedure was not provided. */ | ||
+ | |||
+ | |||
+ | The company did not have a written procedure in place for complaint handling. | ||
+ | |This is the overall summary of the observation that built from the above columns. | ||
| | | | ||
+ | |- | ||
+ | |CREATEDBYNAME | ||
+ | |VARCHAR2(100 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |John Smith | ||
+ | |This identifies the resource that created the record. | ||
+ | |- | ||
+ | |CREATEDON | ||
+ | |DATE | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |22-08-26 | ||
+ | |This identifies the date that record was created. | ||
| | | | ||
+ | |- | ||
+ | |MODIFIEDBYNAME | ||
+ | |VARCHAR2(100 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |John Smith | ||
+ | |This identifies the resource that last modified the record. | ||
| | | | ||
− | |} | + | |- |
+ | |MODIFIEDON | ||
+ | |DATE | ||
+ | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |22-08-26 | ||
+ | |This identifies the date that record was last modified. | ||
+ | | | ||
+ | |} | ||
− | === | + | ===MD_INS_INS_CASE_WORKFLOW=== |
[[MDCCD Data Warehouse|Return to Home Page.]] | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
− | This table holds information | + | This table holds information about the workflow of the inspection. |
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
! scope="col" style="width: 100px;" |DataType | ! scope="col" style="width: 100px;" |DataType | ||
− | ! scope="col" style="width: 50px;" |Key Type | + | ! scope="col" style="width: 50px;" | Key Type |
! scope="col" style="width: 50px;" |Nullable | ! scope="col" style="width: 50px;" |Nullable | ||
! scope="col" style="width: 50px;" |Data Default | ! scope="col" style="width: 50px;" |Data Default | ||
! scope="col" style="width: 500px;" |Example Data | ! scope="col" style="width: 500px;" |Example Data | ||
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
! scope="col" style="width: 350px;" |Comments | ! scope="col" style="width: 350px;" |Comments | ||
|- | |- | ||
− | | | + | |WF_ID |
− | | | + | |VARCHAR2(36 CHAR) |
− | | | + | |Primary |
− | | | + | |No |
− | | | + | |NULL |
− | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
+ | |This is the unique record identifier for the workflow. | ||
| | | | ||
|- | |- | ||
+ | |WF_NAME | ||
+ | |VARCHAR2(50 BYTE) | ||
| | | | ||
− | | | + | |Yes |
− | | | + | |NULL |
− | | | + | |Inspection Business Process |
− | | | + | |This is the name of the workflow. |
− | |||
| | | | ||
|- | |- | ||
+ | |INSP_ID | ||
+ | |VARCHAR2(36 CHAR) | ||
+ | |Foreign | ||
+ | |No | ||
+ | |NULL | ||
+ | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | ||
+ | |This is the unique record identifier for the parent inspection. | ||
+ | |Use to join with MD_INS_CASE.INSP_ID. | ||
+ | |- | ||
+ | |INSP_NUM | ||
+ | |VARCHAR2(200 CHAR) | ||
+ | | | ||
+ | |No | ||
+ | |NULL | ||
+ | |00070-MDCCD HEALTHCARE INC | ||
+ | |This is the parent inspection number. | ||
+ | | | ||
+ | |- | ||
+ | |ACTIVESTAGEID | ||
+ | |VARCHAR2(36 CHAR) | ||
| | | | ||
+ | |No | ||
+ | |NULL | ||
+ | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | ||
+ | |This is the unique record identifier for the current stage of the workflow. | ||
| | | | ||
+ | |- | ||
+ | |STAGE_NAME_EN | ||
+ | |VARCHAR2(50 BYTE) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Start Of Inspection | ||
+ | |This is the name of the current workflow stage in English. | ||
| | | | ||
+ | |- | ||
+ | |STAGE_NAME_FR | ||
+ | |VARCHAR2(50 BYTE) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |Début de l'inspection | ||
+ | |This is the name of the current workflow stage in French. | ||
| | | | ||
+ | |- | ||
+ | |STAGE_START_DATE | ||
+ | |DATE | ||
| | | | ||
− | | | + | |Yes |
− | + | |NULL | |
− | + | |23-11-09 | |
− | + | |This is the date that the current workflow stage was started. | |
− | |||
− | This | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
| | | | ||
+ | |- | ||
+ | |WF_COMPLETE_DATE | ||
+ | |DATE | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |23-11-09 | ||
+ | |This is the date the workflow was completed. | ||
| | | | ||
+ | |- | ||
+ | |WF_DURATION | ||
+ | |NUMBER(4,0) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |42 | ||
+ | |This identifies how many days the workflow was active. | ||
| | | | ||
|- | |- | ||
+ | |CREATEDBYNAME | ||
+ | |VARCHAR2(100 CHAR) | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |John Smith | ||
+ | |This identifies the resource that created the record. | ||
| | | | ||
+ | |- | ||
+ | |CREATEDON | ||
+ | |DATE | ||
| | | | ||
+ | |Yes | ||
+ | |NULL | ||
+ | |22-08-26 | ||
+ | |This identifies the date that record was created. | ||
+ | |- | ||
+ | |MODIFIEDBYNAME | ||
+ | |VARCHAR2(100 CHAR) | ||
| | | | ||
− | | | + | |Yes |
− | | | + | |NULL |
+ | |John Smith | ||
+ | |This identifies the resource that last modified the record. | ||
| | | | ||
|- | |- | ||
+ | |MODIFIEDON | ||
+ | |DATE | ||
| | | | ||
− | | | + | |Yes |
− | | | + | |NULL |
− | | | + | |22-08-26 |
− | | | + | |This identifies the date that record was last modified. |
− | |||
| | | | ||
|} | |} | ||
− | === | + | |
+ | ===MD_INS_INS_IID=== | ||
[[MDCCD Data Warehouse|Return to Home Page.]] | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
− | This table holds information | + | This table holds the Initial Inspection Deficiency information for an inspection that is posted on the DHPID. |
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
|+ | |+ | ||
! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
! scope="col" style="width: 100px;" |DataType | ! scope="col" style="width: 100px;" |DataType | ||
− | ! scope="col" style="width: 50px;" |Key Type | + | ! scope="col" style="width: 50px;" | Key Type |
! scope="col" style="width: 50px;" |Nullable | ! scope="col" style="width: 50px;" |Nullable | ||
! scope="col" style="width: 50px;" |Data Default | ! scope="col" style="width: 50px;" |Data Default | ||
! scope="col" style="width: 500px;" |Example Data | ! scope="col" style="width: 500px;" |Example Data | ||
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
! scope="col" style="width: 350px;" |Comments | ! scope="col" style="width: 350px;" |Comments | ||
|- | |- | ||
Line 1,573: | Line 1,804: | ||
| | | | ||
| | | | ||
− | | | + | | |
− | + | |- | |
− | + | | | |
− | + | | | |
− | + | | | |
− | + | | | |
− | + | | | |
− | + | | | |
− | + | | | |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
| | | | ||
Line 1,613: | Line 1,837: | ||
| | | | ||
| | | | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
| | | | ||
Line 1,651: | Line 1,859: | ||
| | | | ||
| | | | ||
− | | | + | | |
− | | | + | | |
− | |} | + | |- |
− | + | | | |
− | === MD_INS_INS_SITE=== | + | | |
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |} | ||
+ | |||
+ | ===MD_INS_INS_INSPECTORLIST=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds a list of inspectors within the system. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" | Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" | Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" |Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |} | ||
+ | |||
+ | ===MD_INS_INS_IRC_ENFORCEMENT=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds the list of enforcement actions taken by Health Canada for the Inspection Report Card posted on the DHPID. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" | Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" | Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" |Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |} | ||
+ | |||
+ | ===MD_INS_INS_IRC_MEASURES=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds the list of corrective measures taken by Health Canada for the Inspection Report Card posted on the DHPID. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" | Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" | Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" |Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |} | ||
+ | |||
+ | ===MD_INS_INS_IRC_OBSERVATIONS=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds the list of observations for the Inspection Report Card posted on the DHPID. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" | Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" | Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" |Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | |- | ||
+ | | | ||
+ | | | ||
+ | | | ||
+ | | | ||
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+ | |} | ||
+ | |||
+ | ===MD_INS_INS_SITE=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds the site/company dictionary. This information is migrated from MDS. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" | Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" | Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" |Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
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+ | |} | ||
+ | |||
+ | ===MD_INS_INS_SITE_CONTACT=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds the site/company contact listing. This information is partially migrated from MDS. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" |Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" |Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" |Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
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+ | |} | ||
+ | |||
+ | ===MD_INS_INS_LICENCE=== | ||
+ | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
+ | |||
+ | This table holds the establishment licence dictionary. This information is migrated from MDS. | ||
+ | {| class="wikitable sortable mw-collapsible" | ||
+ | |+ | ||
+ | ! scope="col" style="width: 350px;" | Column Name | ||
+ | ! scope="col" style="width: 100px;" |DataType | ||
+ | ! scope="col" style="width: 50px;" | Key Type | ||
+ | ! scope="col" style="width: 50px;" |Nullable | ||
+ | ! scope="col" style="width: 50px;" |Data Default | ||
+ | ! scope="col" style="width: 500px;" |Example Data | ||
+ | ! scope="col" style="width: 350px;" | Description | ||
+ | ! scope="col" style="width: 350px;" |Comments | ||
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+ | |||
+ | ===MD_INS_INS_SITELICENCEACTIVITY=== | ||
[[MDCCD Data Warehouse|Return to Home Page.]] | [[MDCCD Data Warehouse|Return to Home Page.]] | ||
− | This table holds information | + | This table holds the establishment licence activity dictionary. This information is migrated from MDS. |
− | {| class="wikitable sortable" | + | {| class="wikitable sortable mw-collapsible" |
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! scope="col" style="width: 350px;" | Column Name | ! scope="col" style="width: 350px;" | Column Name | ||
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! scope="col" style="width: 50px;" |Data Default | ! scope="col" style="width: 50px;" |Data Default | ||
! scope="col" style="width: 500px;" |Example Data | ! scope="col" style="width: 500px;" |Example Data | ||
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
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Latest revision as of 14:10, 28 August 2024
This page has been highlighted as a candidate for deletion. Please see the discussion. Reason: Moved to internal Health Canada wiki. Internal database structure should not be public. |
Overview
This page provides a data dictionary for each table that is held within the MDCCD Data Warehouse.
DISCLAIMER: All data in the "Example Data" column is fictitious and does not represent parties authorized under the Food and Drugs Act and/or the Medical Device Regulations.
Medical Devices
MD_INS_CASE
This table holds the main inspection information.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
INSP_ID | Primary | VARCHAR2(36 CHAR) | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the inspection. | |
INSP_NUM | Foreign | VARCHAR2(200 CHAR) | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the inspection number. | |
SITE_ID | Foreign | VARCHAR2(36 CHAR) | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the company inspected. | |
SITE_NAME | VARCHAR2(160 CHAR) | Yes | NULL | MDCCD HEALTHCARE INC | This is the name of the company insepcted. | ||
LICENCE_NO | Foreign | NUMBER(6,0) | Yes | NULL | 1234 | This is the establishment licence number of the company inspected. | Use to join with MDS table ESTABLISHMENT.ESTABLISHMENT_ID. |
COMPANY_ID | Foreign | NUMBER(6,0) | Yes | NULL | 123456 | This is the internal Health Canada company identifier. | Use to join with MDS table ESTABLISHMENT.COMPANY_ID or COMPANY.COMPANY_ID. |
REG_FILE_NUMBER | VARCHAR2(250 BYTE) | Yes | NULL | HC1-11-11IM | This is the internal program based file identifier. | ||
REGION_CD_EN | VARCHAR2(50 CHAR) | Yes | NULL | East | This is the operational centre assigned to the inspection in English. | ||
REGION_CD_FR | VARCHAR2(50 CHAR) | Yes | NULL | Est | This is the operational centre assigned to the inspection in French. | ||
INSP_TYPE_EN | VARCHAR2(100 CHAR) | Yes | NULL | Domestic - New - Onsite | This is the type of inspection in English. | ||
INSP_TYPE_FR | VARCHAR2(100 CHAR) | Yes | NULL | Domestique - Nouvelle - Sur place | This is the type of inspection in French. | ||
LEAD_INSPECTOR_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | 0bb101ab-5009-ee11-8f6e-000d3ae86452 | This is the unique record identifier of the lead inspector. | |
LEAD_INSPECTOR | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the name of the lead inspector. | ||
LEAD_INSPECTOR_BADGE | VARCHAR2(50 BYTE) | Yes | NULL | 9988776 | This is the badge number of the lead inspector. | ||
SUPERVISOR_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier of the supervisor for the inspection. | |
SUPERVISOR | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the name of the supervisor for the inspection. | ||
INSP_STATUS_EN | VARCHAR2(100 CHAR) | Yes | NULL | Open | This is the status of the inspection in English. | ||
INSP_STATUS_FR | VARCHAR2(100 CHAR) | Yes | NULL | Ouvert | This is the status of the inspection in French. | ||
COMP_STANDARD_EN | VARCHAR2(100 CHAR) | Yes | NULL | Food & Drugs Act, Medical Device Regulations | This is the compliance standard that the site was inspected against in English. Either the FDA or MDR. | ||
COMP_STANDARD_FR | VARCHAR2(100 CHAR) | Yes | NULL | Loi sur les aliments et drogues, Règlement sur les instruments médicaux | This is the compliance standard that the site was inspected against in French. Either the FDA or MDR. | ||
DRAFT_REPORT_RATING_EN | VARCHAR2(100 CHAR) | Yes | NULL | Compliant | This is the draft inspection rating in English. | ||
DRAFT_REPORT_RATING_FR | VARCHAR2(100 CHAR) | Yes | NULL | Conforme | This is the draft inspection rating in French. | ||
DRAFT_REPORT_ISSUE_DATE | DATE | Yes | NULL | 24-03-21 | This is the date that the draft inspection rating was issued. | ||
FINAL_REPORT_RATING_EN | VARCHAR2(100 CHAR) | Yes | NULL | Compliant | This is the final inspection rating in English. | ||
FINAL_REPORT_RATING_FR | VARCHAR2(100 CHAR) | Yes | NULL | Conforme | This is the final inspection rating in French. | ||
FINAL_REPORT_ISSUE_DATE | DATE | Yes | NULL | 24-03-21 | This is the date that the final inspection rating was issued. | ||
AMENDED_REPORT_ISSUE_DATE | DATE | Yes | NULL | 24-03-22 | This is the date that an amended inspection report was issued to the company. | ||
SAMPLES_TAKEN | VARCHAR2(2000 CHAR) | Yes | NULL | None | This indicates if any samples were taken during the inspection. | ||
INSP_START_DATE | DATE | Yes | NULL | 24-01-30 | This indicates when the inspection was started. | Use this to calculate the number of inspections per month for the dashboard. | |
INSP_END_DATE | DATE | Yes | NULL | 24-01-30 | This indicates when the inspection was finished. | Use this to calculate the number of completed inspections per month/quarterly compliance ratings for the dashboard. | |
CLOSING_MEETING_DATE | DATE | Yes | NULL | 23-11-15 | This indicates when the inspector had the closing meeting with the company. | ||
NEXT_INSPECTION_DATE | DATE | Yes | NULL | 24-03-15 | This indicates when the company is due for its next inspection | ||
AMENDED_CD_EN | VARCHAR2(5 CHAR) | Yes | NULL | Yes | This indicates whether the inspection report has been amended in English. | ||
AMENDED_CD_FR | VARCHAR2(5 CHAR) | Yes | NULL | Oui | This indicates whether the inspection report has been amended in French. | ||
AMENDED_BY | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This indicates who amended the inspection. | ||
AMENDED_DATE | DATE | Yes | NULL | 24-03-01 | This indicates when the report was amended. | ||
FIRST_COMM_DATE | DATE | Yes | NULL | 24-02-21 | This is the date the inspector first communicated with the company for the inspection. | ||
FIRST_COMM_MODE | VARCHAR2(100 CHAR) | Yes | NULL | This is how the inspector first communicated with the company for the inspection. | |||
FIRST_COMM_MODE_EN | VARCHAR2(100 CHAR) | Yes | NULL | This is how the inspector first communicated with the company for the inspection in English. | |||
FIRST_COMM_MODE_FR | VARCHAR2(100 CHAR) | Yes | NULL | This is how the inspector first communicated with the company for the inspection in French. | |||
EMERGENCY_CONTACT_NAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This is the name of the emergency contact for the company at the time of inspection. | ||
EMERGENCY_CONTACT_PHONE | VARCHAR2(100 CHAR) | Yes | NULL | 613-123-4567 | This is the phone number of the emergency contact for the company at the time of inspection. | ||
SENIOR_OFFICIAL_OFFICIAL_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier of the senior official of the company at the time of insepction. | |
SENIOR_OFFICIAL_NAME | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the name of the senior official for the company at the time of inspection. | ||
SENIOR_OFFICIAL_TITLE | VARCHAR2(100 CHAR) | Yes | NULL | General Manager | This is the job title of the senior official for the company at the time of inspection. | ||
SITE_CONTACT_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier of the contact of the company at the time of inspection. | |
SITE_CONTACT_NAME | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the name of the contact of the company at the time of inspection. | ||
SITE_CONTACT_TITLE | VARCHAR2(100 CHAR) | Yes | NULL | Manger, Quality Assurance | This is the job title of the contact of the company at the time of inspection. | ||
SITE_CONTACT_PHONE | VARCHAR2(100 CHAR) | Yes | NULL | 613-123-4567 | This is the phone number of the contact of the company at the time of inspection. | ||
SITE_CONTACT_FAX | VARCHAR2(100 CHAR) | Yes | NULL | 613-123-4567 | This is the fax of the contact of the company at the time of inspection. | ||
SITE_CONTACT_EMAIL | VARCHAR2(100 CHAR) | Yes | NULL | john@mdccdhealthcare.com | This is the e-mail of the contact of the company at the time of inspection. | ||
SITE_ADDRESS_1 | VARCHAR2(250 CHAR) | Yes | NULL | 123 Main St | This is the address of the company being inspected. | ||
SITE_ADDRESS_2 | VARCHAR2(250 CHAR) | Yes | NULL | Suite 101 | This is secondary the address of the company being inspected. | ||
SITE_ADDRESS_3 | VARCHAR2(250 CHAR) | Yes | NULL | This is the tertiary address of the company being inspected. | |||
SITE_CITY | VARCHAR2(80 CHAR) | Yes | NULL | OTTAWA | This is the city of the company being inspected. | ||
SITE_PROVINCE | VARCHAR2(50 CHAR) | Yes | NULL | ON | This is the province of the company being inspected. | ||
SITE_POSTALCODE | VARCHAR2(20 CHAR) | Yes | NULL | A1B 2C3 | This is the postal code of the company being inspected. | ||
SITE_COUNTRY | VARCHAR2(80 CHAR) | Yes | NULL | CANADA | This is the country of the company being inspected. | ||
INSPECTION_SUMMARY | CLOB | Yes | NULL | The meeting occured on March 1, 1994 with John Smith (Manager at MDCCD Healthcare and Mohamed Ali (Inspector at Health Canada) | This is the inspectors summary of the inspection. | ||
REPORT_DELIVERED_TO_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier of the contact of the company who received the final inspection report. | |
REPORT_DELIVERED_TO | VARCHAR2(200 CHAR) | Yes | NULL | Mohamed Ali | This is the name of the contact of the company who received the final inspection report. | ||
RESPONSE_EXPECTED_DATE | DATE | Yes | NULL | 24-02-28 | This is the date that Health Canada is expecting a response from the company about information captured in the final inspection report. | ||
INTERNAL_CLOSING_COMMENTS | CLOB | Yes | NULL | 20230406 Inspector spoke with company to schedule inspection. Follow-up email sent to company. | This is the inspector's internal comments and recommendations after the completion of the inspection. | ||
PERSONNEL_CHANGES | VARCHAR2(2000 BYTE) | Yes | NULL | Change in Regulatory Affairs department. Mr. Smith now in charge of complaint handling. | This indicates any personnel changes at the company inspected since their previous inspection. | ||
IID_STATUS_EN | VARCHAR2(50 CHAR) | Yes | NULL | In Progress | This indicates the status of the IID in English. | DHPID Transparency IID | |
IID_STATUS_FR | VARCHAR2(50 CHAR) | Yes | NULL | En cours | This indicates the status of the IID in French. | DHPID Transparency IID | |
IID_STATUS_DATE | DATE | Yes | NULL | 24-03-15 | This indicates the status date of the IID. | DHPID Transparency IID | |
IID_REVISION_LOG | VARCHAR2(2000 CHAR) | Yes | NULL | Updated deficiency. | This indicates any revisions carried out to the IID. | DHPID Transparency IID | |
IRC_STATUS_EN | VARCHAR2(50 CHAR) | Yes | NULL | IRC Ready For Publication | This indicates the status of the IRC in English. | DHPID Transparency IRC | |
IRC_STATUS_FR | VARCHAR2(50 CHAR) | Yes | NULL | IRC prêt pour la publication | This indicates the status of the IRC in French. | DHPID Transparency IRC | |
INSP_RATING_EN | VARCHAR2(100 CHAR) | Yes | NULL | Compliant | This indicates the final inspection report rating for the IRC in English. | DHPID Transparency IRC.
Matches the FINAL_REPORT_RATING_EN value. | |
INSP_RATING_FR | VARCHAR2(100 CHAR) | Yes | NULL | Conforme | This indicates the final inspection report rating for the IRC in French. | DHPID Transparency IRC.
Matches the FINAL_REPORT_RATING_FR value. | |
INSP_OUTCOME_EN | VARCHAR2(2000 CHAR) | Yes | NULL | The inspection resulted in a ‘compliant’ inspection rating. A compliant inspection rating allows a company to keep their licence and continue conducting business. A compliant rating does not mean that there were no observations during the inspection. If a company receives a compliant inspection rating and if observations were noted, the company is required to develop a plan to correct the observations to prevent them from occurring again. | This is a standard line related to the INSP_RATING_EN value. | DHPID Transparency IRC | |
INSP_OUTCOME_FR | VARCHAR2(2000 CHAR) | Yes | NULL | Une cote « conforme » a été émise aux termes de l’inspection. \r\n\r\nUne cote d’inspection « conforme » permet à une entreprise de conserver sa licence et de poursuivre ses activités. Une cote « conforme » ne signifie toutefois pas qu’aucune observation n’a été relevée pendant l’inspection. Si une entreprise reçoit une cote d’inspection « conforme » et si des observations ont été relevées, elle doit élaborer un plan pour corriger ces observations et éviter qu’elles ne se reproduisent | This is a standard line related to the INSP_RATING_FR value. | DHPID Transparency IRC | |
INSP_REPORT_WAITING | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the inspector's name who sent the inspection report for approval in the record log. | ||
INSP_REPORT_WAITING_DATE | DATE | Yes | NULL | 23-11-27 | This is the date the inspector sent the inspection report for approval in the recocrd log. | ||
INSP_REPORT_APPROVED_BY | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the supervisor's name who approved the inspection report in the record log. | ||
INSP_REPORT_APPROVED_BY_DATE | DATE | Yes | NULL | 23-11-27 | This is the date the supervisor approved the inspection report in the record log. | ||
INSP_CLOSED_WAITING | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the inspector's name who sent the inspection for closure in the record log. | ||
INSP_CLOSED_WAITING_DATE | DATE | Yes | NULL | 23-11-29 | This is the date the inspector sent the inspection report for closure in the record log. | ||
INSP_CLOSED_APPROVED | VARCHAR2(200 CHAR) | Yes | NULL | John Smith | This is the supervisor's name who approved the inspection for closure in the record log. | ||
INSP_CLOSED_APPROVED_DATE | DATE | Yes | NULL | 23-11-29 | This is the date the supervisor approved the inspection for closure in the record log. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 23-08-14 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 23-12-25 | This identifies the date that record was last modified. |
MD_INS_CASE_CAPA
This table holds information about the corrective action plan for an inspection observation.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
CAPA_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the CAPA. | |
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | Foreign | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | |
OBS_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent observation the CAPA is linked to. | |
CAPA_TYPE | VARCHAR2(100 CHAR) | Yes | NULL | Follow Up Plan | This is a free text field used to identify the type of CAPA. | ||
CAPA_PLAN | VARCHAR2(2000 CHAR) | Yes | NULL | The manufacturer sent an email to the inspector to indicate that the program has been solved. | This is the CAPA as inputted by the inspector. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_CASE_DESIGNATION
This table holds information that categorizes or "tags" an inspection. These are flexible codes used to capture information if a designated field does not exist.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
INSP_DESIGNATION_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the designation. | |
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | Foreign | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | |
DESIGNATION_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the designation code. | |
DESIGNATION_CODE | VARCHAR2(100 CHAR) | Yes | NULL | 5006 | This is the designation code. | ||
DESIGNATION_NAME | VARCHAR2(250 CHAR) | Yes | NULL | Covid | This is the name of the designation code. | ||
DESIGNATION_DECODE_EN | VARCHAR2(100 CHAR) | Yes | NULL | Covid | This is the name of the designation code in English. | ||
DESIGNATION_DECODE_FR | VARCHAR2(100 CHAR) | Yes | NULL | Covid | This is the name of the designation code in French. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_CASE_ESTACTIVITY
This table holds information on the activities conducted by the company at the time of the inspection as recorded by the inspector.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
INSP_ACTIVITY_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the establishment activity. | |
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | Foreign | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | |
ACTIVITY_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the activity value. | |
ACTIVITY_NAME | VARCHAR2(205 CHAR) | Yes | NULL | Importateur - Classe 2 | This is the establishment activity. | ||
ACTIVITY_DECODE_EN | VARCHAR2(100 CHAR) | Yes | NULL | Importer - Class 2 | This is the name of the establishment activity in English. | ||
ACTIVITY_DECODE_FR | VARCHAR2(100 CHAR) | Yes | NULL | Importateur - Classe 2 | This is the name of the establishment activity in French. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_CASE_INSPECTORS
This table holds a listing of inspectors assigned to an inspection.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
BK_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the inspector listing. | |
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | Foreign | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | |
INSPECTOR_NAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This is the name of the inspector. | ||
LEADINSPECTOR_EN | VARCHAR2(3 CHAR) | Yes | NULL | Yes | This indicates if the inspector is the lead inspector on the inspection in English. | ||
LEADINSPECTOR_FR | VARCHAR2(3 CHAR) | Yes | NULL | Oui | This indicates if the inspector is the lead inspector on the inspection in French. | ||
ASSIGNSTATUS_EN | VARCHAR2(100 CHAR) | Yes | NULL | Scheduled | **Not used by program.** | Contains default system information. | |
ASSIGNSTATUS_FR | VARCHAR2(100 CHAR) | Yes | NULL | **Not used by program.** | Contains default system information. | ||
STARTTIME | DATE | Yes | NULL | 23-10-20 | **Not used by program.** | Contains default system information. | |
ENDTIME | DATE | Yes | NULL | 23-10-20 | **Not used by program.** | Contains default system information. | |
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_CASE_NOTES
This table holds notes related to the inspection.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
ANNOTATION_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the note. | |
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | Foreign | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | |
SUBJECT | VARCHAR2(500 CHAR) | Yes | NULL | Talked to client and set out inspection plan. | This is the subject of the note. | ||
NOTETEXT | CLOB | Yes | NULL | Communication with company on 2023-09-01. | This is the body of the note. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_CASE_OBSERVATIONS
This table holds information about the observations for an inspection.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
OBS_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the observation. | |
OBS_NUM | VARCHAR2(200 CHAR) | No | NULL | 00070-MDCCD HEALTHCARE INC -obs0001132 | This is the observation number. | ||
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | Foreign | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | |
OBS_TYPE_EN | VARCHAR2(200 CHAR) | Yes | NULL | MDR - Establishment licence | This identifies the overall category of the Medical Device Regulations that the observation is cited under in English. | ||
OBS_TYPE_FR | VARCHAR2(200 CHAR) | Yes | NULL | RIM - Licence d’établissement | This identifies the overall category of the Medical Device Regulations that the observation is cited under in French. | ||
REG_SECTION_EN | VARCHAR2(150 CHAR) | Yes | NULL | s.45 (f) Device classes | This identifies the specific section/subsection of the Medical Device Regulations that the observation is cited under in English. | ||
REG_SECTION_FR | VARCHAR2(150 CHAR) | Yes | NULL | MDR s.45 (f) Classes des instruments | This identifies the specific section/subsection of the Medical Device Regulations that the observation is cited under in French. | ||
OBS_RISK | NUMBER(1,0) | Yes | NULL | 1 | This identifies the risk level of the observation. | Scale 1-3. Risk 1 is the highest and risk 3 is the lowest. | |
OBS_REPEAT_EN | VARCHAR2(30 CHAR) | Yes | NULL | Repeat Observation | This indicates if the observation has occurred before on a previous inspection with the company in English. | ||
OBS_REPEAT_FR | VARCHAR2(30 CHAR) | Yes | NULL | Observation répétée | This indicates if the observation has occurred before on a previous inspection with the company in French. | ||
OBS_STATUS_EN | VARCHAR2(50 CHAR) | Yes | NULL | Open | This indicates the status of the observation in English. | ||
OBS_STATUS_FR | VARCHAR2(50 CHAR) | Yes | NULL | Ouvert | This indicates the status of the observation in French. | ||
OBS_INCLUDEREPORT_EN | VARCHAR2(3 CHAR) | Yes | NULL | Yes | This indicates whether the observation is included on the inspection report in English. | ||
OBS_INCLUDEREPORT_FR | VARCHAR2(3 CHAR) | Yes | NULL | Oui | This indicates whether the observation is included on the inspection report in French. | ||
OBS_SEQ_NUM | NUMBER(3,0) | Yes | NULL | 1 | This indicates the order that the observations will print on the inspection report. | ||
OBS_STDLINE_EN | VARCHAR2(1000 CHAR) | Yes | NULL | A written procedure was not provided. | This is a standard line related to the section of the regulation cited in English. | ||
OBS_STDLINE_FR | VARCHAR2(1000 CHAR) | Yes | NULL | Une procédure écrite n'avait pas été fournie | This is a standard line related to the section of the regulation cited in French. | ||
OBS_NARRATIVE | VARCHAR2(4000 CHAR) | Yes | NULL | /*A written procedure was not provided. */
|
This is the inspector's narrative related to the observation. | ||
OBS_SUMMARY | VARCHAR2(2000 CHAR) | Yes | NULL | Observation #: 01
Status / Statut : Open / Ouvert Risk / Risque : 1 MDR - Establishment licence / RIM - Licence d’établissement MDR s.45 (f) Device classes / MDR s.45 (f) Classes des instruments
|
This is the overall summary of the observation that built from the above columns. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_INS_CASE_WORKFLOW
This table holds information about the workflow of the inspection.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
WF_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the workflow. | |
WF_NAME | VARCHAR2(50 BYTE) | Yes | NULL | Inspection Business Process | This is the name of the workflow. | ||
INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the parent inspection. | Use to join with MD_INS_CASE.INSP_ID. |
INSP_NUM | VARCHAR2(200 CHAR) | No | NULL | 00070-MDCCD HEALTHCARE INC | This is the parent inspection number. | ||
ACTIVESTAGEID | VARCHAR2(36 CHAR) | No | NULL | 5c6afa3c-3f8a-4641-8da4-9588ec7769d7 | This is the unique record identifier for the current stage of the workflow. | ||
STAGE_NAME_EN | VARCHAR2(50 BYTE) | Yes | NULL | Start Of Inspection | This is the name of the current workflow stage in English. | ||
STAGE_NAME_FR | VARCHAR2(50 BYTE) | Yes | NULL | Début de l'inspection | This is the name of the current workflow stage in French. | ||
STAGE_START_DATE | DATE | Yes | NULL | 23-11-09 | This is the date that the current workflow stage was started. | ||
WF_COMPLETE_DATE | DATE | Yes | NULL | 23-11-09 | This is the date the workflow was completed. | ||
WF_DURATION | NUMBER(4,0) | Yes | NULL | 42 | This identifies how many days the workflow was active. | ||
CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that created the record. | ||
CREATEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was created. | ||
MODIFIEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | John Smith | This identifies the resource that last modified the record. | ||
MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
MD_INS_INS_IID
This table holds the Initial Inspection Deficiency information for an inspection that is posted on the DHPID.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_INSPECTORLIST
This table holds a list of inspectors within the system.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_IRC_ENFORCEMENT
This table holds the list of enforcement actions taken by Health Canada for the Inspection Report Card posted on the DHPID.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_IRC_MEASURES
This table holds the list of corrective measures taken by Health Canada for the Inspection Report Card posted on the DHPID.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_IRC_OBSERVATIONS
This table holds the list of observations for the Inspection Report Card posted on the DHPID.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_SITE
This table holds the site/company dictionary. This information is migrated from MDS.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_SITE_CONTACT
This table holds the site/company contact listing. This information is partially migrated from MDS.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_LICENCE
This table holds the establishment licence dictionary. This information is migrated from MDS.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|
MD_INS_INS_SITELICENCEACTIVITY
This table holds the establishment licence activity dictionary. This information is migrated from MDS.
Column Name | DataType | Key Type | Nullable | Data Default | Example Data | Description | Comments |
---|---|---|---|---|---|---|---|