Issue link: https://iconnect007.uberflip.com/i/1259453
64 PCB007 MAGAZINE I JUNE 2020 • Should/may – Non-critical – Non-compliance would not jeopardize operation – Leaves room for external circumstances • Examples – "Bath pH shall be verified and logged onto form 203-004 every two hours." – "Workplace should be kept clean on a continual basis." Further, always use the term "designee." For example: • Don't: "The molding supervisor shall review and sign-off on the daily SPC results." • Do: "The molding supervisor, or his/her designee, shall review and sign-off on the daily SPC results." Tip 4: Intelligent Conventions If you are certified to an international QMS standard, such as ISO 9001 or AS9100, now that the powers that be have "harmonized" the standards, it is a great idea to number your sys- tem to align with the standard. For example, procedures, work instructions, forms, and at- tachments are numbered using the following number scheme with the prefix representing the type of document: • QM: Quality manual • QP: QMS procedure • XX: Manufacturing work instruction (XX=department abbreviation) • F=Form • A=Attachment Some examples include: • The internal audit procedure that relates to section 9.2 is numbered as QP-920 • F-920-1 is the first form for the internal audit procedure QP-920 • Work instructions can start with WI, a three-digit department code, and a sequential number (e.g., WI-DRL-1=first work instruction for the drill department) • Same format for forms (WI-DRL-1-1=first form for WI-DRL) This makes it easy to identify all forms as- sociated with each procedure or work instruc- tion. Also, try to avoid an automatic sequential numbering scheme (QP 102345C) and large procedure numbers. Tip 5: Reference Documents Add a "reference documents" section to ev- ery procedure: • Easy form maintenance • Facilitates training • Do not include form revision • Reduces time-to-retrieval • Assists in revision purge • Helps maintain system integrity Tip 6: Purge Control Develop a control mechanism for revision purges. Don't take a "hands-off" approach and assume individual departments will effectively purge. Tip 7: Keep Six Months of Quality Records at the Work Source Have posted procedures at the work source (paper or electronic). For instance, a 3" binder will easily hold 180 pages (six months). This allows quick and easy access and retrieval, cal- ibrates with six-month surveillance audits, and provides finite history to verify. Tip 8: 'Outlaw' White-Out Do not allow White-Out in the facility. You can write exceptions into document control procedures for correspondence if absolutely necessary. Have a "controlled substance" men- tality; it's a simple matter of discipline. Teach "line, sign, date" (LSD) and audit to it inter- nally Tip 9: Eliminate Blanks Issue edict: No forms shall have blanks. If a form has a section no longer used, remove it and revise the form. For instance: • Infrequent non-use, line through, or "N/A": Write clause into the document control procedure