Standard Operating Procedure DOCUMENT CONTROL

Transcription

1 Standard Operating Procedure DOCUMENT CONTROL STATISTIC AND QUALITY ENGINEERING LABORATORY Universitas Brawijaya Malang 2017

2 IDENTIFICATION SHEET UNIVERSITAS BRAWIJAYA DOCUMENT CONTROL UN10/F07/88/HK a/002 November 17 th Page i from 6 DOCUMENT CONTROL Process Person in Charge Name Position Signature Date 1. Arranged Fachrezy Pangestu Widi Assistant Coordinator November 17 th Corrected Debrina Puspita Andriani, ST., M.Eng. 3. Approved Ishardita Pambudi Tama ST., MT., Ph.D. 4. Determined Dr. Ir. Pitojo Tri Juwono, MT. 5. Controlled Dr. Ir. Surjono, MTP. Head of Head of the Department of Industrial Engineering Dean of The Faculty of Engineering Vice Dean for Academic Affair November 17 th 2017 November 20 th 2017 November 20 th 2017 November 20 th 2017 Page i

3 TABLE OF CONTENTS IDENTIFICATION SHEET i TABLE OF CONTENTS ii A. Objective B. Scope and Related Units C. Related Quality Standard D. Terms and Definition E. Sequence of Procedures F. Flowchart G. Reference H. Attachment Page ii

4 A. Objective The objective of established laboratory document control are: 1. Establish, maintain, and restrict the system to control all documents and records related to the organization s quality system. 2. Ensure that all documents related quality has been assessed and approved adequately. B. Scope and Related Units Scope of document control are all quality documents, such as Manual Procedures (MP), Work Instruction (WI), Organization Structures (OS), Job description of each divition, and all document related to the external standard of quality. Related parties to document control SQE are head of Statistic and Quality Engineering Industrial engineering Universitas Brawijaya, along with the entire SQE laboratory assistant responsible for entering data, process data and distribute information, as well as archive footage print (hardcopy) in accordance with the validity period of the document. C. Related Quality Standard Related quality standards of laboratory document control are information management standards and data that received and owned by Statistic and Quality Engineering. And in the management of archiving print records according to the validity period of the document is stored. D. Terms and Definition The terms and definition in laboratory document control are: 1. Quality Audit Document is a document that used as a tool to run Internal Quality Assurance System. Quality document include SOP, WI, Recording Forms, and Documents. All documents must meet the standards of the quality system. 2. Standard Operating Procedure (SOP) is a document that contains the procedures to execute a process. SOP described as a step by step flow of activities in a process carried out by each person in charge, along with an explanation for the procedures for its implementation. 3. Work Instruction is a document that explains the technical implementation of an activity that support the service procedure. Page 1

5 4. Documents are information and media supporters (can be paper, electronic files/digital, compact disc/cd, etc). Document Statistics and Quality Engineering are divided into (a) internal document, (b) external documents, (c) recording. 5. Recording or work program accountability report is a document that stating results achieved or providing evidence of activities performed. 6. Supporting documents are other documents as reference in operational activities. E. Sequence of Procedures 1. Document Control Procedures A. The responsible for work program, all assistant and Head of Statistic and Quality Engineering give information to administrative division to make letter document that required. B. Administrative division make the letter corresponding to the number of letters. C. Letters printed out already consulted with the Assistant Coordinator, and the case of revisions, administrative division shall correct it. D. Outgoing mail has been consulted and approved by the Coordinator of Chief Assistant subsequently endorsed by signing the signature column is prepared, and if necessary approval from the Head of the Department, the letter must be signed in advance by the Head of Department. E. The letter has been signed by the parties agree, given the stamp of laboratory and stamp majors with blue ink. F. The letter, which is already stamped duplicated and scanned as archives laboratory. G. File scan mail stored in a special folder on Computer Server SQE and duplicated mail archives stored in folders with labels mail archives. H. Letter distributed by the person responsible to the intended party. I. Incoming mail or from outsiders who aimed to recorded and stored on incoming mail folder and duplicated as an archive. 2. Audit Document or Quality Document Control Procedures A. Division of Quality Assurance create Work Instructions, Standard Operating Procedure, Forms Record and coordinate all the assistants to prepare all the necessary documents for the audit. B. If the application linking another division, then the document should be reviewed by the relevant division, and if necessary with the part of the user documents, in order to reach an agreement. Page 2

6 C. Division of Quality Assurance and other divisions author of the document must give identity to the following documents. Title/Name Number Publication Date Approval authorities Status change (revision) for the SOP document D. The quality documents that has been made must be consulted to the Head of SQE then Head of authorize or approve the quality documents. E. Division of Quality Assurance kept all quality documents by grouping them according to clause in accordance with the relevant documents.. F. Division of Quality Assurance shall be responsible for updating the SOP if there is a change. 3. Records Control Procedures A. Every person in charge for any work program must save all documentation of activities. B. Person in charge for the work program make the accountability report containing the objectives of the activities, the results of the achievements that have been achieved and the constraints faced and documentation activities C. Person in charge for the work program provide any record documents or accountability report to the Quality Assurance division to be consulted to the Head of the. D. Once it being approved and signed by the Head of, the record documents is saved by the QA division to make an audit or archive. 4. Supported Document Control Procedures A. Each person in charge of the entire operation as well as the assistant must keep all documents relevant to the activities of the work program in the folder are set apart with a given label. B. For Practicum document, every person in charge of the module are obliged to keep all documents practicum in a special folder module concerned. C. Administrative division is responsible for printing and saving documents meeting Presence assistant and head of the are stored based on semester. Page 3

7 F. Flowchart 1. Flowchart of Letter Document Control Start Assistant in charge and Administration Division Related parties gave information to administration division to create required letter. (1 day) Administration Division Administration Division made letter corresponding to the number of letter (1 day) Letter Documents Assistant coordinator and assistant of laboratory Consult the letter documents to assistant coordinator and assistant coordinator signed the letter documents. (1 day) Head of and laboratory Consult the letter documents to Head of and Head of signed the letter documents. (1 day) Stamped the the letter documents that have been signed (1 day) Duplicate stamped letter documents (1 day) Copied letter documents Scan Scanned letter document file Distribute letter to the related parties (1-2 days) Copied letter documents are stored in hardcopy and softcopy as an archive (1 day) Finish Page 4

8 2. Flowchart of Audit Document Control Procedures Start (Quality Assurance Division) Entire related Assisant Create SOP, WI, Record Form Documents (1 month) SOP, WI, Record Form Documents (Quality Assurance Division) Head of Consult the created documents to Head of (1 month) (Quality Assurance Division) Stored the SOP, WI, and Record Form Documents ( 1 month) (Quality Assurance Division) Head of Updates the documents if it necessary (3 months) Finished 3. Supported Document Control Flowchart Start Assistant in charge of documents Storage all work program documents by given the label (7 days) Work program documents Practicum Coordinator and Administration Division Storage all practicum documents in practicum folder (6 months) Practicum documents Administration Division Print presence document and store them in presence folder (1 day) Presence and practicum documents Finish Page 5

9 G. Reference 1. Manual Quality Guide Industrial Engineering Department Universitas Brawijaya 2. Standar Nasional Indonesia (SNI) Quality Management System Requirements ISO 9001:2008, National Standardization Agency H. Attachment 1. Result of Meeting Work Instruction 2. Practicum Report Archiving and Extermination Work Instruction 3. Making of Letters Out Work Instruction 4. Acceptance of Letters In Work Instruction Page 6

10 ATTACHMENT 1 : Result of Meeting Work Instruction A. Objectives 1. To explain operational and the result of laboratory meeting at Statisic and Quality Engineering. 2. To ease the steps on storage the result of laboratory meeting by using systematic procedure. B. Scope and Related Parties Scope for the making of result laboratory meeting are all results of meetings conducted by the laboratory are recorded and recorded along with news events or list of attendance of the laboratory parties. Related parties of the making of result laboratory meeting are Head of Statistic and Quality Engineering and entire assistant of SQE. C. Definition Result of laboratory meeting is a record result of the discussion at the meeting activities carried out whether by the laboratory assistant with head of laboratory or meetings that were attended only by the laboratory assistants to discusss all the laboratorium work program that will be held. D. Write Down Result of Meeting Work Instruction Procedures 1. the administrative division record all results of the discussion in the meeting held by the laboratory to the result of laboratory meeting book. 2. the administrative divisions copy the result of laboratory meeting by re-typing on the computer. 3. the administrative division save the result of laboratory meeting in the file storage on server computer in the of Statistics and Quality Engineering. 4. the administrative division print the result of laboratory meeting. 5. administrative divisions store print-out of the meeting along with the news event into a specific folder for the result of laboratory meeting and news event.

11 E. Write Down Result of Meeting Flowchart Start administrative division Record all results of the discussion in the meeting held by the laboratory (1 day) Meeting Book administrative division Copied the result of laboratory meeting by re-typing on the computer (1 day) administrative division Saving the result of laboratory meeting in the file storage on server computer (1 hour) administrative division Print the result of laboratory meeting (1 hour) Print-Out of Result of Meeting Document administrative division Store print-out of the meeting along with the news event into a specific folder (1 day) Finish

12 ATTACHMENT 2 : Practicum Report Archiving and Extermination Work Instruction A. Objectives 1. To explain the procedures of practicum report archiving and extermination which exists in the Statistics and Quality Engineering. 2. To ease the steps of practicum report archiving and extermination from the equipments available with a systematically organized procedures. B. Scope and Related Parties This practicum report archiving and extermination procedures is addressed to the equipments available in Statistics and Quality Engineering. Practicum report consist of Industrial Statistics Practicum Report and Integrated Practicum II report. Here are the related parties of practicum report archiving and extermination: 1. Statistics and Quality Engineering 2. Practicum applicants 3. Relevant Lecturers C. Definition Practicum report is a report that contains about the module material that is the background to the conclusion. The Industrial Statistics Practicum Report consists of modules 1-3 which address issues concerning industry statistics, probabilities, and anova tests. The Integrated Practicum II Model consists of 4 modules covering market segmentation, product specification, selection development and concept testing, and product design. At the end of the deadline, the practitioners are required to compile their practical reports as evidence that they have practiced. D. Practicum Report Archiving and Extermination Procedures The Procedures of practicum report archiving and extermination will be explained here. This extermination process will be committed only for the previous 1 generations by transferring them from the laboratory. One example if there is a report from generation 2005 until 2015, therefore they will

13 exterminate report from generation 2005 and 2014 only however they will take 5 report each from every generation for safe keeping. Meanwhile the report from generation 2015 will be kept. Here are the steps of practicum report archiving and extermination: 1. Check how many practical reports from which generation that have been kept. 2. There are 7 generations, then the previous 6 generations practice report will be exterminated, but 5 report from each generation will kept as a history. 3. The practicum report from new generations will be archived in the laboratory. administrative division stored results of meeting files in server computer to specific folder of Statistic and Quality Engineering. E. Report Archiving and Extermination Flowchart Start Check how many the existing report practicum generation (1 day) No Is there 5 generations? Yes The previous generations practice report will be exterminated, but 5 report from each generation will kept as a history ( 1 day) 5 practicum report of each generation The practice report from the newest generations will be conserved in laboratory ( 1 day) Newest generation practicum report Finish

14 ATTACHMENT 3 : Making of Letters Out Work Instruction A. Objectives Explain the work instructions of a letter out laboratory devoted to external laboratory. B. Scope and Related Parties Work instructions making of letters out this laboratory is intended as a reference laboratory assistants to make the lab a letter to parties outside the laboratory. Here are related parties of the making of letters out: 1. Head of Statistics and Quality Engineering 2. Statistics and Quality Engineering 3. Outside parties intended C. Definition Letters out is the letter that is created by the laboratory devoted to outside parties of laboratory solicitations over something that is needed by the laboratory so that it can support a work program which is held by laboratory. D. Making of Letters Out Work Instruction Procedures 1. Head of the laboratory and the assistant who needs a letter out informing the administrative division assistant to make the required letter. 2. Administrative division assistant make the required letter. 3. Assistant administrative divisions consult letter to the assistant coordinator and requested signature assistant coordinators. 4. Assistant coordinator consult letter to the head of the laboratory and requested signature head of the laboratory. 5. Assistant provides laboratory inked stamp on the signature blue on the head of the laboratory signature. 6. assistant ask for signature of other parties concerned if any. 7. assistant in the form of soft copy files by clicking on the scan and in hard files with photocopying the letter that has been signed and stamped by all parties is needed. 8. Assistants deploy a letter to the intended party.

15 E. Making of Letters Out Flowchart Start Head of Inform the administrative division to make a letter (1 day) administrative division Make the corresponding letter (1 day) Letters out administrative division Head of Consult letter to the assistant coordinator and requested assistant coordinator signature (1 day) Consult letter to the Head of and requested for Head of signature (1 day) Providing laboratory inked stamp on the signature blue coordinator assistant and head of the laboratory (1 day) Request signatures of other parties concerned if any (1 day) Copy in the form of soft file with updating the scan and in the form of hard file by posting a copy of the letter (1 day) Spread the letters to the parties intended (1-2 days) Finished

16 ATTACHMENT 4 : Acceptance of Letters In Work Instruction A. Objectives 1. Describes work instructions laboratory receipt of letters in from outside parties aimed at laboratory. 2. Describes work instructions storage of letters in addressed to laboratories from outside parties. B. Scope and Related Parties Scope letters in work instructions are entire assistants of SQE that intended as a reference for the assistants to receive and store the letters from outside parties aimed at laboratory. Here are the related parties of the acceptance of letters in at SQE : 1. Head of Statistics and Quality Engineering 2. Statistics and Quality Engineering 3. Outside parties intended C. Definition Letters in are letter that is created by an outside party laboratory devoted to the internal laboratory as apply to something that is needed by outside laboratories so as to support the work program held by outsiders laboratory. D. Acceptance of Letters In Work Instruction Procedures 1) Head of the laboratory receives letter addressed from outside the laboratory. 2) Head of the laboratory give letter to the assistant of laboratory 3) Head of the laboratory to confirm the request of letter and instructed assistants to meet the request for letters 4) meet the request of letter 5) store letters in a special folder that contains the letter addressed to the laboratory.

17 E. Letters In Flowchart Start Head of laboratory Head of laboratory receices letter addressed from outside the laboratory (1 day) Letters in from outside parties Head of Head of laboratory give letter to the assistant of laboratory (1 day) Head of Head of the laboratory to confirm the request of letter and instructed assistants to meet the request for Letters (1 day) laboratory meet the rewuest of letter (1 day) Stored letters in a specific folder (1 day) Finished

18 TIMELINE OF DOCUMENT CONTROL 2017 January MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY SUNDAY Memberika informasi ke divisi administrasi terkait surat Div.administrasi membuat surat yang bersangkutan Mengkonsultasikan dokumen ke koordinator asisten Mengkonsultasikan dokumen ke kepala laboratorium Memberikan stempel laboratorium Menggandakan dokumen surat Pendistribusian surat pada pihak terkait Penggandaan dokumen surat Penyimpanan seluruh dokumen program kerja Penyimpanan seluruh dokumen program kerja Penyimpanan seluruh dokumen program kerja Penyimpanan seluruh dokumen program kerja Penyimpanan seluruh dokumen program kerja Penyimpanan seluruh dokumen program kerja Penyimpanan seluruh dokumen program kerja Notes: Pengendalian Dokumen Surat bersifat kondisional; Penyimpanan seluruh dokumen diletakkan di map= 6 bulan