Difference between revisions of "MDCCD Data Warehouse Data Dictionary"
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| Line 22: | Line 22: | ||
|No | |No | ||
|NULL | |NULL | ||
| − | | | + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
|This is the unique record identifier for the inspection. | |This is the unique record identifier for the inspection. | ||
| | | | ||
| Line 31: | Line 31: | ||
|No | |No | ||
|NULL | |NULL | ||
| − | | | + | |00070-QUART HEALTHCARE INC. |
|This is the inspection number. | |This is the inspection number. | ||
| | | | ||
| Line 40: | Line 40: | ||
|No | |No | ||
|NULL | |NULL | ||
| − | | | + | |7b06cddd-12d5-ee11-904d-002248b0a560 |
|This is the unique record identifier for the company inspected. | |This is the unique record identifier for the company inspected. | ||
| | | | ||
| Line 49: | Line 49: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |QUART HEALTHCARE INC. |
|This is the name of the company insepcted. | |This is the name of the company insepcted. | ||
| | | | ||
| Line 58: | Line 58: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |2027 |
|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 67: | Line 67: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |107232 |
|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 76: | Line 76: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |HC6-61-123/IM |
|This is the internal program based file identifier. | |This is the internal program based file identifier. | ||
| | | | ||
| Line 85: | Line 85: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |East |
|This is the operational centre assigned to the inspection in English. | |This is the operational centre assigned to the inspection in English. | ||
| | | | ||
| Line 94: | Line 94: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Est |
|This is the operational centre assigned to the inspection in French. | |This is the operational centre assigned to the inspection in French. | ||
| | | | ||
| Line 103: | Line 103: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Domestic - New - Onsite |
|This is the type of inspection in English. | |This is the type of inspection in English. | ||
| | | | ||
| Line 112: | Line 112: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Domestique - Nouvelle - Sur place |
|This is the type of inspection in French. | |This is the type of inspection in French. | ||
| | | | ||
| Line 121: | Line 121: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |0bb101ab-5009-ee11-8f6e-000d3ae86452 |
|This is the unique record identifier of the lead inspector. | |This is the unique record identifier of the lead inspector. | ||
| | | | ||
| Line 130: | Line 130: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Vanessa Toussaint |
|This is the name of the lead inspector. | |This is the name of the lead inspector. | ||
| | | | ||
| Line 139: | Line 139: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |54355335 |
|This is the badge number of the lead inspector. | |This is the badge number of the lead inspector. | ||
| | | | ||
| Line 148: | Line 148: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |ed91a4cf-777a-ee11-8179-002248b32010 |
|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 157: | Line 157: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Ada Lai |
|This is the name of the supervisor for the inspection. | |This is the name of the supervisor for the inspection. | ||
| | | | ||
| Line 166: | Line 166: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Open |
|This is the status of the inspection in English. | |This is the status of the inspection in English. | ||
| | | | ||
| Line 175: | Line 175: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Ouvert |
|This is the status of the inspection in French. | |This is the status of the inspection in French. | ||
| | | | ||
| Line 184: | Line 184: | ||
|Yes | |Yes | ||
|NULL | |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. | |This is the compliance standard that the site was inspected against in English. Either the FDA or MDR. | ||
| | | | ||
| Line 193: | Line 193: | ||
|Yes | |Yes | ||
|NULL | |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. | |This is the compliance standard that the site was inspected against in French. Either the FDA or MDR. | ||
| | | | ||
| Line 202: | Line 202: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Compliant |
|This is the draft inspection rating in English. | |This is the draft inspection rating in English. | ||
| | | | ||
| Line 211: | Line 211: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Conforme |
|This is the draft inspection rating in French. | |This is the draft inspection rating in French. | ||
| | | | ||
| Line 220: | Line 220: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |24-03-21 |
|This is the date that the draft inspection rating was issued. | |This is the date that the draft inspection rating was issued. | ||
| | | | ||
| Line 229: | Line 229: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Compliant |
|This is the final inspection rating in English. | |This is the final inspection rating in English. | ||
| | | | ||
| Line 238: | Line 238: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Conforme |
|This is the final inspection rating in French. | |This is the final inspection rating in French. | ||
| | | | ||
| Line 247: | Line 247: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |24-03-21 |
|This is the date that the final inspection rating was issued. | |This is the date that the final inspection rating was issued. | ||
| | | | ||
| Line 256: | Line 256: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |24-03-22 |
|This is the date that an amended inspection report was issued to the company. | |This is the date that an amended inspection report was issued to the company. | ||
| | | | ||
| Line 265: | Line 265: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |None |
|This indicates if any samples were taken during the inspection. | |This indicates if any samples were taken during the inspection. | ||
| | | | ||
| Line 274: | Line 274: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |24-01-30 |
|This indicates when the inspection was started. | |This indicates when the inspection was started. | ||
|Use this to calculate the number of inspections per month for the dashboard. | |Use this to calculate the number of inspections per month for the dashboard. | ||
| Line 283: | Line 283: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |24-01-30 |
|This indicates when the inspection was finished. | |This indicates when the inspection was finished. | ||
|Use this to calculate the number of completed inspections per month/quarterly compliance ratings for the dashboard. | |Use this to calculate the number of completed inspections per month/quarterly compliance ratings for the dashboard. | ||
| Line 292: | Line 292: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |23-11-15 | ||
| + | |This indicates when the inspector had the closing meeting with the company. | ||
| | | | ||
| − | |||
|- | |- | ||
|NEXT_INSPECTION_DATE | |NEXT_INSPECTION_DATE | ||
| Line 300: | Line 301: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |24-03-15 | ||
| + | |This indicates when the company is due for its next inspection | ||
| | | | ||
| − | |||
|- | |- | ||
|AMENDED_CD_EN | |AMENDED_CD_EN | ||
| Line 308: | Line 310: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |Yes | ||
| + | |This indicates whether the inspection report has been amended in English. | ||
| | | | ||
| − | |||
|- | |- | ||
|AMENDED_CD_FR | |AMENDED_CD_FR | ||
| Line 316: | Line 319: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |Oui | ||
| + | |This indicates whether the inspection report has been amended in French. | ||
| | | | ||
| − | |||
|- | |- | ||
|AMENDED_BY | |AMENDED_BY | ||
| Line 324: | Line 328: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |Vanessa Toussaint | ||
| + | |This indicates who amended the inspection. | ||
| | | | ||
| − | |||
|- | |- | ||
|AMENDED_DATE | |AMENDED_DATE | ||
| Line 332: | Line 337: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |24-03-01 | ||
| + | |This indicates when the report was amended. | ||
| | | | ||
| − | |||
|- | |- | ||
|FIRST_COMM_DATE | |FIRST_COMM_DATE | ||
| Line 340: | Line 346: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |24-02-21 | ||
| + | |This is the date the inspector first communicated with the company for the inspection. | ||
| | | | ||
| − | |||
|- | |- | ||
|FIRST_COMM_MODE | |FIRST_COMM_MODE | ||
| Line 348: | Line 355: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |E-mail | ||
| + | |This is how the inspector first communicated with the company for the inspection. | ||
| | | | ||
| − | |||
|- | |- | ||
|FIRST_COMM_MODE_EN | |FIRST_COMM_MODE_EN | ||
| Line 358: | Line 366: | ||
| | | | ||
|This is how the inspector first communicated with the company for the inspection in English. | |This is how the inspector first communicated with the company for the inspection in English. | ||
| + | | | ||
|- | |- | ||
|FIRST_COMM_MODE_FR | |FIRST_COMM_MODE_FR | ||
| Line 366: | Line 375: | ||
| | | | ||
|This is how the inspector first communicated with the company for the inspection in French. | |This is how the inspector first communicated with the company for the inspection in French. | ||
| + | | | ||
|- | |- | ||
|EMERGENCY_CONTACT_NAME | |EMERGENCY_CONTACT_NAME | ||
| Line 372: | Line 382: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |John Smith | ||
| + | |This is the name of the emergency contact for the company at the time of inspection. | ||
| | | | ||
| − | |||
|- | |- | ||
|EMERGENCY_CONTACT_PHONE | |EMERGENCY_CONTACT_PHONE | ||
| Line 380: | Line 391: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |514-123-4566 | ||
| + | |This is the phone number of the emergency contact for the company at the time of inspection. | ||
| | | | ||
| − | |||
|- | |- | ||
|SENIOR_OFFICIAL_OFFICIAL_ID | |SENIOR_OFFICIAL_OFFICIAL_ID | ||
| Line 388: | Line 400: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |31175da9-efdf-ee11-904c-000d3a847fce | ||
| + | |This is the unique record identifier of the senior official of the company at the time of insepction. | ||
| | | | ||
| − | |||
|- | |- | ||
|SENIOR_OFFICIAL_NAME | |SENIOR_OFFICIAL_NAME | ||
| Line 396: | Line 409: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| + | |SVEN LILLEDRU | ||
| + | |This is the name of the senior official for the company at the time of inspection. | ||
| | | | ||
| − | |||
|- | |- | ||
|SENIOR_OFFICIAL_TITLE | |SENIOR_OFFICIAL_TITLE | ||
| Line 404: | Line 418: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |G.M. |
|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 412: | Line 426: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |c1d2e077-eddf-ee11-904d-002248b0ad37 |
|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 421: | Line 435: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |SVEN LILLEORU |
|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 430: | Line 444: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |MANAGER, COMMERCIAL QUALITY & REG EU & CAN |
|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 439: | Line 453: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |416-765-0345 |
|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 447: | Line 461: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |514-123-4567 |
|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 456: | Line 470: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |sven@quarthealthcare.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 465: | Line 479: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |36 NORTHLINE ROAD, SUITE 9 |
|This is the address of the company being inspected. | |This is the address of the company being inspected. | ||
| | | | ||
| Line 474: | Line 488: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Suite 101 |
|This is secondary the address of the company being inspected. | |This is secondary the address of the company being inspected. | ||
| | | | ||
| Line 492: | Line 506: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |TORONTO |
|This is the city of the company being inspected. | |This is the city of the company being inspected. | ||
|- | |- | ||
| Line 500: | Line 514: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |ON |
|This is the province of the company being inspected. | |This is the province of the company being inspected. | ||
| | | | ||
| Line 509: | Line 523: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |M4B 3E2 |
|This is the postal code of the company being inspected. | |This is the postal code of the company being inspected. | ||
| | | | ||
| Line 518: | Line 532: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |CANADA |
|This is the country of the company being inspected. | |This is the country of the company being inspected. | ||
| | | | ||
| Line 527: | Line 541: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |La réunion d'ouverture a eu lieu le 29 mars 2023 à distance (via VidCruiter) en présence de Éric Simard (Vice-Président et Secrétaire Trésorier de 1164250921 Quebec Inc Dba Kasla Entreprise Inc.) et My Din Phan (Inspecteur de Santé Canada). |
|This is the inspectors summary of the inspection. | |This is the inspectors summary of the inspection. | ||
| | | | ||
| Line 536: | Line 550: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |c7e5bef2-ecdf-ee11-904c-6045bd60a7a2 |
|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 545: | Line 559: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |MARILU ALEJANDRA VALERIANO |
|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 554: | Line 568: | ||
|Yes | |Yes | ||
|NULL | |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. | |This is the date that Health Canada is expecting a response from the company about information captured in the final inspection report. | ||
| | | | ||
| Line 563: | Line 577: | ||
|Yes | |Yes | ||
|NULL | |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. | |This is the inspector's internal comments and recommendations after the completion of the inspection. | ||
| | | | ||
| Line 572: | Line 586: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Change in Regulatory affairs department. Ms. Pace 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 581: | Line 595: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |In Progress |
|This indicates the status of the IID in English. | |This indicates the status of the IID in English. | ||
|DHPID Transparency IID | |DHPID Transparency IID | ||
| Line 590: | Line 604: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |En cours |
|This indicates the status of the IID in French. | |This indicates the status of the IID in French. | ||
|DHPID Transparency IID | |DHPID Transparency IID | ||
| Line 599: | Line 613: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |24-03-15 |
|This indicates the status date of the IID. | |This indicates the status date of the IID. | ||
|DHPID Transparency IID | |DHPID Transparency IID | ||
| Line 608: | Line 622: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Updated deficiency. |
|This indicates any revisions carried out to the IID. | |This indicates any revisions carried out to the IID. | ||
|DHPID Transparency IID | |DHPID Transparency IID | ||
| Line 617: | Line 631: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |IRC Ready For Publication |
|This indicates the status of the IRC in English. | |This indicates the status of the IRC in English. | ||
|DHPID Transparency IRC | |DHPID Transparency IRC | ||
| Line 626: | Line 640: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |IRC prêt pour la publication |
|This indicates the status of the IRC in French. | |This indicates the status of the IRC in French. | ||
|DHPID Transparency IRC | |DHPID Transparency IRC | ||
| Line 635: | Line 649: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Compliant |
|This indicates the final inspection report rating for the IRC in English. | |This indicates the final inspection report rating for the IRC in English. | ||
| − | |DHPID Transparency IRC. Matches the FINAL_REPORT_RATING_EN value. | + | |DHPID Transparency IRC. |
| + | Matches the FINAL_REPORT_RATING_EN value. | ||
|- | |- | ||
|INSP_RATING_FR | |INSP_RATING_FR | ||
| Line 644: | Line 659: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Conforme |
|This indicates the final inspection report rating for the IRC in French. | |This indicates the final inspection report rating for the IRC in French. | ||
| − | |DHPID Transparency IRC. Matches the FINAL_REPORT_RATING_FR value. | + | |DHPID Transparency IRC. |
| + | Matches the FINAL_REPORT_RATING_FR value. | ||
|- | |- | ||
|INSP_OUTCOME_EN | |INSP_OUTCOME_EN | ||
| Line 653: | Line 669: | ||
|Yes | |Yes | ||
|NULL | |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. | |This is a standard line related to the INSP_RATING_EN value. | ||
|DHPID Transparency IRC | |DHPID Transparency IRC | ||
| Line 662: | Line 678: | ||
|Yes | |Yes | ||
|NULL | |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. | |This is a standard line related to the INSP_RATING_FR value. | ||
|DHPID Transparency IRC | |DHPID Transparency IRC | ||
| Line 671: | Line 687: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Jeff Tyndall |
|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 680: | Line 696: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |23-11-27 |
|This is the date the inspector sent the inspection report for approval in the recocrd log. | |This is the date the inspector sent the inspection report for approval in the recocrd log. | ||
| | | | ||
| Line 689: | Line 705: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Vanessa Toussaint |
|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 698: | Line 714: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |23-11-27 |
|This is the date the supervisor approved the inspection report in the record log. | |This is the date the supervisor approved the inspection report in the record log. | ||
| | | | ||
| Line 707: | Line 723: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Jeff Tyndall |
|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 715: | Line 731: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |23-11-29 |
|This is the date the inspector sent the inspection report for closure in the record log. | |This is the date the inspector sent the inspection report for closure in the record log. | ||
| | | | ||
| Line 724: | Line 740: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Vanessa Toussaint |
|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 733: | Line 749: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |23-11-29 |
|This is the date the supervisor approved the inspection for closure in the record log. | |This is the date the supervisor approved the inspection for closure in the record log. | ||
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|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Vanessa Toussaint |
|This identifies the resource that created the record. | |This identifies the resource that created the record. | ||
| | | | ||
| Line 751: | Line 767: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |23-08-14 |
|This identifies the date that record was created. | |This identifies the date that record was created. | ||
| | | | ||
| Line 760: | Line 776: | ||
|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |Vanessa Toussaint |
|This identifies the resource that las modified the record. | |This identifies the resource that las modified the record. | ||
| | | | ||
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|Yes | |Yes | ||
|NULL | |NULL | ||
| − | | | + | |23-12-25 |
|This identifies the date that record was last modified. | |This identifies the date that record was last modified. | ||
| | | | ||
Revision as of 15:58, 23 May 2024
Overview
This page provides a data dictionary for each table that is held within the MDCCD Data Warehouse.
Medical Devices
MD_INS_CASE
This table holds the main inspection information.
| Column Name | Key Type | DataType | 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 | VARCHAR2(200 CHAR) | No | NULL | 00070-QUART HEALTHCARE INC. | This is the inspection number. | ||
| SITE_ID | Foreign | VARCHAR2(36 CHAR) | No | NULL | 7b06cddd-12d5-ee11-904d-002248b0a560 | This is the unique record identifier for the company inspected. | |
| SITE_NAME | VARCHAR2(160 CHAR) | Yes | NULL | QUART HEALTHCARE INC. | This is the name of the company insepcted. | ||
| LICENCE_NO | Foreign | NUMBER(6,0) | Yes | NULL | 2027 | 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 | 107232 | 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 | HC6-61-123/IM | 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 | Vanessa Toussaint | This is the name of the lead inspector. | ||
| LEAD_INSPECTOR_BADGE | VARCHAR2(50 BYTE) | Yes | NULL | 54355335 | This is the badge number of the lead inspector. | ||
| SUPERVISOR_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | ed91a4cf-777a-ee11-8179-002248b32010 | This is the unique record identifier of the supervisor for the inspection. | |
| SUPERVISOR | VARCHAR2(200 CHAR) | Yes | NULL | Ada Lai | 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 | Vanessa Toussaint | 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 | 514-123-4566 | 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 | 31175da9-efdf-ee11-904c-000d3a847fce | 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 | SVEN LILLEDRU | This is the name of the senior official for the company at the time of inspection. | ||
| SENIOR_OFFICIAL_TITLE | VARCHAR2(100 CHAR) | Yes | NULL | G.M. | 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 | c1d2e077-eddf-ee11-904d-002248b0ad37 | 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 | SVEN LILLEORU | This is the name of the contact of the company at the time of inspection. | ||
| SITE_CONTACT_TITLE | VARCHAR2(100 CHAR) | Yes | NULL | MANAGER, COMMERCIAL QUALITY & REG EU & CAN | This is the job title of the contact of the company at the time of inspection. | ||
| SITE_CONTACT_PHONE | VARCHAR2(100 CHAR) | Yes | NULL | 416-765-0345 | This is the phone number of the contact of the company at the time of inspection. | ||
| SITE_CONTACT_FAX | VARCHAR2(100 CHAR) | Yes | NULL | 514-123-4567 | This is the fax of the contact of the company at the time of inspection. | ||
| SITE_CONTACT_EMAIL | VARCHAR2(100 CHAR) | Yes | NULL | sven@quarthealthcare.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 | 36 NORTHLINE ROAD, SUITE 9 | 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 | TORONTO | 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 | M4B 3E2 | 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 | La réunion d'ouverture a eu lieu le 29 mars 2023 à distance (via VidCruiter) en présence de Éric Simard (Vice-Président et Secrétaire Trésorier de 1164250921 Quebec Inc Dba Kasla Entreprise Inc.) et My Din Phan (Inspecteur de Santé Canada). | This is the inspectors summary of the inspection. | ||
| REPORT_DELIVERED_TO_ID | Foreign | VARCHAR2(36 CHAR) | Yes | NULL | c7e5bef2-ecdf-ee11-904c-6045bd60a7a2 | 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 | MARILU ALEJANDRA VALERIANO | 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. Ms. Pace 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 | Jeff Tyndall | 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 | Vanessa Toussaint | 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 | Jeff Tyndall | 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 | Vanessa Toussaint | 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 | Vanessa Toussaint | 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 | Vanessa Toussaint | This identifies the resource that las 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 | Data Type | Key Type | Nullable | Data Default | Example Data | Description | Comments |
|---|---|---|---|---|---|---|---|
| CAPA_ID | VARCHAR2(36 CHAR) | Primary | No | NULL | ad5e55f6-8b21-ee11-9966-000d3ae86452 | This is the unique record identifier for the CAPA. | |
| INSP_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 3d7a309e-ce46-40c5-a6c2-f3ea80971d48 | 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 | 00086-BENEMAX DBA. BENEMAX HEALTH AND WELLNESS | This is the parent inspection number. | ||
| OBS_ID | VARCHAR2(36 CHAR) | Foreign | No | NULL | 07244e35-fbf1-ee11-a1fe-6045bd6005cc | 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 inspector sent follow-up letter to address Physio-controls response--the manufacturer can have more than one ID on the label as long as it clearly marks what the device identifier is and that this identifier matches what is in the MDALL. March 6, 2024 The company sent follow-up from manufacturer. The manufacturer has sent in a fax back to Health Canada to include the device ID (11141-000165) under their license. This adequately addresses the observation. | This is the CAPA as inputted by the inspector. | ||
| CREATEDBYNAME | VARCHAR2(100 CHAR) | Yes | NULL | Jeff Tyndall | 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 | Jeff Tyndall | This identifies the resource that las modified the record. | ||
| MODIFIEDON | DATE | Yes | NULL | 22-08-26 | This identifies the date that record was last modified. |
